Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial

January 16, 2025 updated by: National Cancer Institute (NCI)

RAndomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial

This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase II) II. To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase III)

SECONDARY OBJECTIVES:

I. To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm.

II. To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and > 3 visible tumors.

III. To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease ("complete consolidation") and patients who do not receive consolidation radiation to all visible disease ("incomplete consolidation").

EXPLORATORY OBJECTIVE:

I. To assess the association between pre-treatment tumor burden (determined by central radiographic assessment, using both tumor number and tumor volume), and PFS and OS benefit.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive atezolizumab intravenously (IV) over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive atezolizumab IV over 30 minutes +/- 10 minutes. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only.

Patients undergo positron emission tomography and computed tomography (PET/CT) scan, computed tomography (CT), and magnetic resonance imaging (MRI) throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham Cancer Center
    • Alaska
    • Arizona
      • Phoenix, Arizona, United States, 85004
      • Phoenix, Arizona, United States, 85054
        • Active, not recruiting
        • Mayo Clinic Hospital in Arizona
      • Scottsdale, Arizona, United States, 85259
        • Active, not recruiting
        • Mayo Clinic in Arizona
      • Tucson, Arizona, United States, 85719
        • Active, not recruiting
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, United States, 85719
        • Active, not recruiting
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
        • Contact:
        • Principal Investigator:
          • Philip E. Lammers
    • California
      • Irvine, California, United States, 92612
        • Recruiting
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Contact:
        • Principal Investigator:
          • Jeremy P. Harris
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Jeremy P. Harris
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center-Pacific Campus
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Suspended
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80907
        • Suspended
        • Rocky Mountain Cancer Centers-Penrose
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central
        • Contact:
          • Site Public Contact
          • Phone Number: 719-365-2406
        • Principal Investigator:
          • Robert J. Hoyer
      • Colorado Springs, Colorado, United States, 80920
        • Recruiting
        • Memorial Hospital North
        • Contact:
          • Site Public Contact
          • Phone Number: 719-364-6700
        • Principal Investigator:
          • Robert J. Hoyer
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • Poudre Valley Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 970-297-6150
        • Principal Investigator:
          • Robert J. Hoyer
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Cancer Care and Hematology-Fort Collins
        • Contact:
        • Principal Investigator:
          • Robert J. Hoyer
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • UCHealth Greeley Hospital
        • Contact:
        • Principal Investigator:
          • Robert J. Hoyer
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Contact:
          • Site Public Contact
          • Phone Number: 970-203-7083
        • Principal Investigator:
          • Robert J. Hoyer
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Recruiting
        • Smilow Cancer Hospital Care Center-Fairfield
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • Greenwich, Connecticut, United States, 06830
        • Recruiting
        • Smilow Cancer Hospital Care Center at Greenwich
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • Guilford, Connecticut, United States, 06437
        • Recruiting
        • Smilow Cancer Hospital Care Center - Guilford
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • Hamden, Connecticut, United States, 06518
        • Recruiting
        • Smilow Cancer Hospital-Hamden Care Center
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • North Haven, Connecticut, United States, 06473
        • Recruiting
        • Yale-New Haven Hospital North Haven Medical Center
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • Stamford, Connecticut, United States, 06902
        • Recruiting
        • Smilow Cancer Hospital Care Center at Long Ridge
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • Torrington, Connecticut, United States, 06790
        • Recruiting
        • Smilow Cancer Hospital-Torrington Care Center
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • Trumbull, Connecticut, United States, 06611
        • Recruiting
        • Smilow Cancer Hospital Care Center-Trumbull
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • Waterbury, Connecticut, United States, 06708
        • Recruiting
        • Smilow Cancer Hospital-Waterbury Care Center
        • Contact:
        • Principal Investigator:
          • Henry S. Park
      • Waterford, Connecticut, United States, 06385
        • Recruiting
        • Smilow Cancer Hospital Care Center - Waterford
        • Contact:
        • Principal Investigator:
          • Henry S. Park
    • Delaware
      • Millville, Delaware, United States, 19967
        • Recruiting
        • Beebe South Coastal Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Helen F Graham Cancer Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Medical Oncology Hematology Consultants PA
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
    • Florida
      • Aventura, Florida, United States, 33180
        • Active, not recruiting
        • Mount Sinai Comprehensive Cancer Center at Aventura
      • Coral Gables, Florida, United States, 33146
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Alan Libardi Dal Pra
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Alan Libardi Dal Pra
      • Jacksonville, Florida, United States, 32224-9980
        • Withdrawn
        • Mayo Clinic in Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 305-243-2647
        • Principal Investigator:
          • Alan Libardi Dal Pra
      • Miami Beach, Florida, United States, 33140
        • Active, not recruiting
        • Mount Sinai Medical Center
      • Orlando, Florida, United States, 32806
      • Weston, Florida, United States, 33331
        • Active, not recruiting
        • Cleveland Clinic-Weston
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Sibo Tian
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
          • Site Public Contact
          • Phone Number: 404-489-9164
        • Principal Investigator:
          • Sibo Tian
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Sibo Tian
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Sibo Tian
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • CTCA at Southeastern Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 770-400-6629
        • Principal Investigator:
          • Kristin A. Higgins
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial Health University Medical Center
        • Contact:
        • Principal Investigator:
          • Michael D. Hasselle
      • Savannah, Georgia, United States, 31405
        • Active, not recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Active, not recruiting
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, United States, 96701
        • Active, not recruiting
        • Hawaii Cancer Care - Westridge
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • Active, not recruiting
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Active, not recruiting
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, United States, 96817
        • Active, not recruiting
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96817
        • Active, not recruiting
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96826
        • Active, not recruiting
        • Kapiolani Medical Center for Women and Children
      • Lihue, Hawaii, United States, 96766
        • Active, not recruiting
        • Wilcox Memorial Hospital and Kauai Medical Clinic
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Boise, Idaho, United States, 83712
        • Suspended
        • Saint Luke's Cancer Institute - Boise
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Fruitland, Idaho, United States, 83619
        • Suspended
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, United States, 83642
        • Suspended
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Nampa, Idaho, United States, 83687
        • Suspended
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, United States, 83301
        • Suspended
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Active, not recruiting
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Active, not recruiting
        • Illinois CancerCare-Canton
      • Carthage, Illinois, United States, 62321
        • Active, not recruiting
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Suspended
        • Centralia Oncology Clinic
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Matthew Koshy
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Suspended
        • Cancer Care Specialists of Illinois - Decatur
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • Elmhurst Memorial Hospital
        • Principal Investigator:
          • Maria I. Quejada
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Active, not recruiting
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Active, not recruiting
        • Illinois CancerCare-Galesburg
      • Galesburg, Illinois, United States, 61401
        • Active, not recruiting
        • Western Illinois Cancer Treatment Center
      • Kewanee, Illinois, United States, 61443
        • Active, not recruiting
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Active, not recruiting
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • Edward Hospital/Cancer Center
        • Principal Investigator:
          • Maria I. Quejada
        • Contact:
          • Site Public Contact
          • Phone Number: 630-646-6075
      • O'Fallon, Illinois, United States, 62269
        • Suspended
        • Cancer Care Center of O'Fallon
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • HSHS Saint Elizabeth's Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Active, not recruiting
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Active, not recruiting
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61615
        • Active, not recruiting
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61636
        • Active, not recruiting
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, United States, 61637
        • Active, not recruiting
        • OSF Saint Francis Medical Center
      • Peru, Illinois, United States, 61354
        • Active, not recruiting
        • Illinois CancerCare-Peru
      • Plainfield, Illinois, United States, 60585
        • Recruiting
        • Edward Hospital/Cancer Center?Plainfield
        • Principal Investigator:
          • Maria I. Quejada
        • Contact:
      • Princeton, Illinois, United States, 61356
        • Active, not recruiting
        • Illinois CancerCare-Princeton
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • UW Health Carbone Cancer Center Rockford
        • Contact:
        • Principal Investigator:
          • Fahrettin Covut
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Springfield, Illinois, United States, 62702
        • Suspended
        • Springfield Clinic
      • Springfield, Illinois, United States, 62702
        • Suspended
        • Southern Illinois University School of Medicine
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Urbana, Illinois, United States, 61801
        • Suspended
        • The Carle Foundation Hospital
      • Washington, Illinois, United States, 61571
        • Active, not recruiting
        • Illinois CancerCare - Washington
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • Mission Cancer and Blood - Ankeny
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Cedar Rapids, Iowa, United States, 52402
        • Recruiting
        • Physicians' Clinic of Iowa PC
        • Contact:
          • Site Public Contact
          • Phone Number: 319-297-2900
        • Principal Investigator:
          • Bharat Jenigiri
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mercy Cancer Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Mission Cancer and Blood - West Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Heartland Oncology and Hematology LLP
        • Contact:
          • Site Public Contact
          • Phone Number: 712-322-4136
        • Principal Investigator:
          • Tien-Shew W. Huang
      • Council Bluffs, Iowa, United States, 51503
        • Recruiting
        • Methodist Jennie Edmundson Hospital
        • Principal Investigator:
          • Tien-Shew W. Huang
        • Contact:
      • Creston, Iowa, United States, 50801
        • Recruiting
        • Greater Regional Medical Center
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Broadlawns Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2200
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mercy Medical Center - Des Moines
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mission Cancer and Blood - Laurel
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50316
        • Suspended
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
        • Principal Investigator:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Mission Cancer and Blood - Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Seema Harichand-Herdt
      • West Des Moines, Iowa, United States, 50266-7700
        • Suspended
        • Methodist West Hospital
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Mercy Medical Center-West Lakes
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Ascension Via Christi Hospitals Wichita
        • Contact:
        • Principal Investigator:
          • Dennis F. Moore
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Health Louisville
        • Principal Investigator:
          • Wangjian Zhong
        • Contact:
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The James Graham Brown Cancer Center at University of Louisville
        • Contact:
          • Site Public Contact
          • Phone Number: 502-562-3429
        • Principal Investigator:
          • Neal E. Dunlap
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Norton Hospital Pavilion and Medical Campus
      • Louisville, Kentucky, United States, 40217
        • Active, not recruiting
        • Norton Audubon Hospital and Medical Campus
      • Louisville, Kentucky, United States, 40241
        • Active, not recruiting
        • Norton Brownsboro Hospital and Medical Campus
      • Louisville, Kentucky, United States, 40245
        • Recruiting
        • UofL Health Medical Center Northeast
        • Principal Investigator:
          • Neal E. Dunlap
        • Contact:
    • Maine
      • Bath, Maine, United States, 04530
        • Recruiting
        • MaineHealth Coastal Cancer Treatment Center
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
      • Portland, Maine, United States, 04102
        • Recruiting
        • Maine Medical Center-Bramhall Campus
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
          • Site Public Contact
          • Phone Number: 207-885-7565
      • Sanford, Maine, United States, 04073
        • Recruiting
        • MaineHealth Cancer Care Center of York County
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
          • Site Public Contact
          • Phone Number: 207-459-1600
      • Scarborough, Maine, United States, 04074
        • Recruiting
        • Maine Medical Center- Scarborough Campus
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
          • Site Public Contact
          • Phone Number: 207-396-8090
          • Email: wrighd@mmc.org
      • South Portland, Maine, United States, 04106
        • Recruiting
        • Maine Medical Partners - South Portland
        • Principal Investigator:
          • Vatche Tchekmedyian
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Active, not recruiting
        • University of Maryland/Greenebaum Cancer Center
      • Bel Air, Maryland, United States, 21014
        • Active, not recruiting
        • UM Upper Chesapeake Medical Center
      • Columbia, Maryland, United States, 21044
        • Active, not recruiting
        • Central Maryland Radiation Oncology in Howard County
      • Glen Burnie, Maryland, United States, 21061
        • Active, not recruiting
        • UM Baltimore Washington Medical Center/Tate Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 617-638-8265
        • Principal Investigator:
          • Umit Tapan
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Memorial Medical Center - University Campus
        • Principal Investigator:
          • William V. Walsh
        • Contact:
    • Michigan
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health Medical Center - Brighton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Canton, Michigan, United States, 48188
        • Recruiting
        • Trinity Health Medical Center - Canton
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Chelsea, Michigan, United States, 48118
      • Clarkston, Michigan, United States, 48346
        • Recruiting
        • McLaren Cancer Institute-Clarkston
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University/Karmanos Cancer Institute
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Weisberg Cancer Treatment Center
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Genesys Hurley Cancer Institute
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Flint, Michigan, United States, 48503
        • Recruiting
        • Hurley Medical Center
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Flint, Michigan, United States, 48532
        • Recruiting
        • McLaren Cancer Institute-Flint
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49048
        • Suspended
        • Ascension Borgess Hospital
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Karmanos Cancer Institute at McLaren Greater Lansing
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • University of Michigan Health - Sparrow Lansing
        • Principal Investigator:
          • Tareq Al baghdadi
        • Contact:
      • Lapeer, Michigan, United States, 48446
        • Recruiting
        • McLaren Cancer Institute-Lapeer Region
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Livonia, Michigan, United States, 48154
        • Recruiting
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Midland, Michigan, United States, 48670
        • Active, not recruiting
        • MyMichigan Medical Center Midland
      • Mount Clemens, Michigan, United States, 48043
        • Recruiting
        • McLaren Cancer Institute-Macomb
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Novi, Michigan, United States, 48374
        • Suspended
        • Henry Ford Health Providence Novi Hospital
      • Port Huron, Michigan, United States, 48060
        • Recruiting
        • McLaren-Port Huron
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • Corewell Health William Beaumont University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
        • Principal Investigator:
          • Inga S. Grills
      • Saginaw, Michigan, United States, 48604
        • Recruiting
        • Oncology Hematology Associates of Saginaw Valley PC
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
      • Saginaw, Michigan, United States, 48601
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Henry Ford Health Providence Southfield Hospital
        • Principal Investigator:
          • Adam M. Forman
        • Contact:
      • Tawas City, Michigan, United States, 48764
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Corewell Health Beaumont Troy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
        • Principal Investigator:
          • Inga S. Grills
      • West Branch, Michigan, United States, 48661
        • Recruiting
        • Saint Mary's Oncology/Hematology Associates of West Branch
        • Contact:
        • Principal Investigator:
          • Tareq Al baghdadi
    • Minnesota
      • Albert Lea, Minnesota, United States, 56007
        • Withdrawn
        • Mayo Clinic Health System in Albert Lea
      • Bemidji, Minnesota, United States, 56601
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Saint Luke's Hospital of Duluth
        • Principal Investigator:
          • Steven R. Bonin
        • Contact:
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Charles Shideman
      • Rochester, Minnesota, United States, 55905
        • Withdrawn
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Principal Investigator:
          • Donald J. Jurgens
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Charles Shideman
    • Mississippi
      • Southhaven, Mississippi, United States, 38671
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Contact:
        • Principal Investigator:
          • Philip E. Lammers
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Columbia, Missouri, United States, 65212
        • Active, not recruiting
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • BJC Outpatient Center at Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
    • Montana
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
        • Contact:
          • Site Public Contact
          • Phone Number: 402-334-4773
        • Principal Investigator:
          • Tien-Shew W. Huang
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 402-354-5144
        • Principal Investigator:
          • Tien-Shew W. Huang
      • Omaha, Nebraska, United States, 68198
        • Active, not recruiting
        • University of Nebraska Medical Center
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Alexander D. Fuld
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Active, not recruiting
        • Cooper Hospital University Medical Center
      • Pennington, New Jersey, United States, 08534
        • Recruiting
        • Capital Health Medical Center-Hopewell
        • Contact:
        • Principal Investigator:
          • Nikhil Thaker
      • Voorhees, New Jersey, United States, 08043
        • Active, not recruiting
        • MD Anderson Cancer Center at Cooper-Voorhees
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Active, not recruiting
        • Lovelace Medical Center-Saint Joseph Square
      • Albuquerque, New Mexico, United States, 87109
        • Active, not recruiting
        • Lovelace Radiation Oncology
      • Albuquerque, New Mexico, United States, 87106
        • Active, not recruiting
        • University of New Mexico Cancer Center
    • New York
      • Bronx, New York, United States, 10461
        • Active, not recruiting
        • Montefiore Medical Center-Einstein Campus
      • Bronx, New York, United States, 10461
        • Active, not recruiting
        • Montefiore Medical Center-Weiler Hospital
      • Bronx, New York, United States, 10467
        • Active, not recruiting
        • Montefiore Medical Center - Moses Campus
      • Camillus, New York, United States, 13031
        • Recruiting
        • Hematology Oncology Associates of CNY at Camillus
        • Contact:
          • Site Public Contact
          • Phone Number: 315-472-7504
        • Principal Investigator:
          • Steven M. Duffy
      • Canandaigua, New York, United States, 14424
        • Active, not recruiting
        • Sands Cancer Center
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Hematology Oncology Associates of Central New York-East Syracuse
        • Contact:
          • Site Public Contact
          • Phone Number: 315-472-7504
        • Principal Investigator:
          • Steven M. Duffy
      • New York, New York, United States, 10029
        • Active, not recruiting
        • Mount Sinai Hospital
      • New York, New York, United States, 10019
        • Active, not recruiting
        • Mount Sinai West
      • New York, New York, United States, 10011
        • Active, not recruiting
        • Mount Sinai Chelsea
      • Rochester, New York, United States, 14642
        • Active, not recruiting
        • University of Rochester
      • Rochester, New York, United States, 14606
        • Active, not recruiting
        • Wilmot Cancer Institute Radiation Oncology at Greece
      • Stony Brook, New York, United States, 11794
        • Recruiting
        • Stony Brook University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-862-2215
        • Principal Investigator:
          • Mark Ashamalla
      • Syracuse, New York, United States, 13210
        • Recruiting
        • State University of New York Upstate Medical University
        • Contact:
          • Site Public Contact
          • Phone Number: 315-464-5476
        • Principal Investigator:
          • Michael D. Mix
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center
        • Contact:
        • Principal Investigator:
          • Aviva Berkowitz
    • North Carolina
      • Albemarle, North Carolina, United States, 28002
        • Recruiting
        • Atrium Health Stanly/LCI-Albemarle
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Benjamin J. Moeller
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Benjamin J. Moeller
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Atrium Health Pineville/LCI-Pineville
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
        • Principal Investigator:
          • Benjamin J. Moeller
      • Charlotte, North Carolina, United States, 28211
        • Recruiting
        • Levine Cancer Institute-SouthPark
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
        • Principal Investigator:
          • Benjamin J. Moeller
      • Charlotte, North Carolina, United States, 28262
        • Recruiting
        • Atrium Health University City/LCI-University
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Benjamin J. Moeller
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Levine Cancer Institute-Ballantyne
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Benjamin J. Moeller
      • Concord, North Carolina, United States, 28025
        • Recruiting
        • Atrium Health Cabarrus/LCI-Concord
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Benjamin J. Moeller
      • Forest City, North Carolina, United States, 28043
        • Recruiting
        • Levine Cancer Institute - Rutherford
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • John H. Heinzerling
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Levine Cancer Institute-Gaston
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Benjamin J. Moeller
      • Hendersonville, North Carolina, United States, 28791
      • Lincolnton, North Carolina, United States, 28092
        • Recruiting
        • Atrium Health Lincoln/LCI-Lincolnton
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Benjamin J. Moeller
      • Matthews, North Carolina, United States, 28104
        • Recruiting
        • Levine Cancer Institute - Union West
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-0600
        • Principal Investigator:
          • John H. Heinzerling
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Atrium Health Union/LCI-Union
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
        • Principal Investigator:
          • Benjamin J. Moeller
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Atrium Health Cleveland/LCI-Cleveland
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • John H. Heinzerling
      • Statesville, North Carolina, United States, 28677
        • Recruiting
        • Wake Forest Baptist Health - Hematology Oncology - Statesville
        • Contact:
          • Site Public Contact
          • Phone Number: 704-872-3630
        • Principal Investigator:
          • Michael K. Farris
      • Winston-Salem, North Carolina, United States, 27157
        • Active, not recruiting
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Akron, Ohio, United States, 44307
        • Recruiting
        • Cleveland Clinic Akron General
        • Contact:
        • Principal Investigator:
          • Praveen Pendyala
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Health Foundation
        • Principal Investigator:
          • Raza A. Khan
        • Contact:
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Contact:
        • Principal Investigator:
          • Emily C. Daugherty
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Gregory M. M. Videtic
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • MetroHealth Medical Center
        • Contact:
        • Principal Investigator:
          • Peter Xie
      • Cleveland, Ohio, United States, 44111
        • Recruiting
        • Cleveland Clinic Cancer Center/Fairview Hospital
        • Contact:
        • Principal Investigator:
          • Gregory M. M. Videtic
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Mount Carmel East Hospital
        • Contact:
        • Principal Investigator:
          • William A. Wilson
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • The Mark H Zangmeister Center
        • Contact:
        • Principal Investigator:
          • William A. Wilson
      • Columbus, Ohio, United States, 43222
        • Recruiting
        • Mount Carmel Health Center West
        • Contact:
        • Principal Investigator:
          • William A. Wilson
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Karl E. Haglund
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Premier Blood and Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 937-276-8320
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Physician LLC - Englewood
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Franklin, Ohio, United States, 45005-1066
        • Recruiting
        • Atrium Medical Center-Middletown Regional Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Miami Valley Cancer Care and Infusion
        • Principal Investigator:
          • Tarek M. Sabagh
        • Contact:
          • Site Public Contact
          • Phone Number: 937-569-7515
      • Independence, Ohio, United States, 44131
        • Recruiting
        • Cleveland Clinic Cancer Center Independence
        • Contact:
        • Principal Investigator:
          • Gregory M. M. Videtic
      • Mansfield, Ohio, United States, 44906
        • Recruiting
        • Cleveland Clinic Cancer Center Mansfield
        • Contact:
        • Principal Investigator:
          • Gregory M. M. Videtic
      • Mayfield Heights, Ohio, United States, 44124
        • Recruiting
        • Hillcrest Hospital Cancer Center
        • Contact:
        • Principal Investigator:
          • Gregory M. M. Videtic
      • Sandusky, Ohio, United States, 44870
        • Recruiting
        • North Coast Cancer Care
        • Contact:
        • Principal Investigator:
          • Gregory M. M. Videtic
      • Strongsville, Ohio, United States, 44136
        • Recruiting
        • Cleveland Clinic Cancer Center Strongsville
        • Contact:
        • Principal Investigator:
          • Gregory M. M. Videtic
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Upper Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • West Chester, Ohio, United States, 45069
        • Recruiting
        • University of Cincinnati Cancer Center-West Chester
        • Contact:
        • Principal Investigator:
          • Emily C. Daugherty
      • Westerville, Ohio, United States, 43081
        • Recruiting
        • Saint Ann's Hospital
        • Contact:
        • Principal Investigator:
          • William A. Wilson
      • Wooster, Ohio, United States, 44691
        • Recruiting
        • Cleveland Clinic Wooster Family Health and Surgery Center
        • Contact:
        • Principal Investigator:
          • Gregory M. M. Videtic
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System Cancer Care Center
        • Contact:
        • Principal Investigator:
          • William A. Wilson
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Recruiting
        • Cancer Centers of Southwest Oklahoma Research
        • Contact:
          • Site Public Contact
          • Phone Number: 877-231-4440
        • Principal Investigator:
          • Tyler Gunter
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Tyler Gunter
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Suspended
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Providence Cancer Institute Clackamas Clinic
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Gresham, Oregon, United States, 97030
        • Active, not recruiting
        • Legacy Mount Hood Medical Center
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Principal Investigator:
          • Dan S. Zuckerman
        • Contact:
      • Portland, Oregon, United States, 97210
        • Active, not recruiting
        • Legacy Good Samaritan Hospital and Medical Center
      • Tualatin, Oregon, United States, 97062
        • Active, not recruiting
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
        • Recruiting
        • UPMC-Heritage Valley Health System Beaver
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Broomall, Pennsylvania, United States, 19008
        • Recruiting
        • Crozer-Keystone Regional Cancer Center at Broomall
        • Contact:
        • Principal Investigator:
          • Benjamin E. Jacobs
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Recruiting
        • Bryn Mawr Hospital
        • Contact:
        • Principal Investigator:
          • Paul B. Gilman
      • Carlisle, Pennsylvania, United States, 17015
        • Recruiting
        • Carlisle Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Chambersburg, Pennsylvania, United States, 17201
        • Recruiting
        • Chambersburg Hospital
        • Contact:
        • Principal Investigator:
          • Sherif F. Yacoub
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Ephrata, Pennsylvania, United States, 17522
        • Recruiting
        • Ephrata Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 717-721-4840
        • Principal Investigator:
          • Sherif F. Yacoub
      • Erie, Pennsylvania, United States, 16505
        • Recruiting
        • UPMC Hillman Cancer Center Erie
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Erie, Pennsylvania, United States, 16544
        • Active, not recruiting
        • Saint Vincent Hospital
      • Farrell, Pennsylvania, United States, 16121
        • Recruiting
        • UPMC Cancer Center at UPMC Horizon
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Gettysburg, Pennsylvania, United States, 17325
        • Recruiting
        • Adams Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
        • Principal Investigator:
          • Sherif F. Yacoub
      • Glen Mills, Pennsylvania, United States, 19342
        • Recruiting
        • Crozer Regional Cancer Center at Brinton Lake
        • Contact:
          • Site Public Contact
          • Phone Number: 610-284-8237
        • Principal Investigator:
          • Benjamin E. Jacobs
      • Greensburg, Pennsylvania, United States, 15601
        • Recruiting
        • UPMC Cancer Centers - Arnold Palmer Pavilion
        • Contact:
          • Site Public Contact
          • Phone Number: 724-838-1900
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Greenville, Pennsylvania, United States, 16125
        • Recruiting
        • UPMC Hillman Cancer Center in Greenville/UPMC Horizon
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Harrisburg, Pennsylvania, United States, 17109
        • Recruiting
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Hershey, Pennsylvania, United States, 17033-0850
        • Recruiting
        • Penn State Milton S Hershey Medical Center
        • Contact:
        • Principal Investigator:
          • Mitchell Machtay
      • Indiana, Pennsylvania, United States, 15701
        • Recruiting
        • IRMC Cancer Center
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Jefferson Hills, Pennsylvania, United States, 15025
        • Active, not recruiting
        • Jefferson Hospital
      • Lebanon, Pennsylvania, United States, 17042
        • Recruiting
        • Sechler Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Sherif F. Yacoub
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Mechanicsburg, Pennsylvania, United States, 17050
        • Recruiting
        • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Media, Pennsylvania, United States, 19063
        • Recruiting
        • Riddle Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Paul B. Gilman
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Hillman Cancer Center - Monroeville
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Monroeville, Pennsylvania, United States, 15146
        • Recruiting
        • UPMC Cancer Center - Monroeville
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Monroeville, Pennsylvania, United States, 15146
        • Active, not recruiting
        • Forbes Hospital
      • Natrona Heights, Pennsylvania, United States, 15065
        • Active, not recruiting
        • Allegheny Valley Hospital
      • New Castle, Pennsylvania, United States, 16105
        • Recruiting
        • UPMC Hillman Cancer Center - New Castle
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Paoli, Pennsylvania, United States, 19301
        • Recruiting
        • Paoli Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Paul B. Gilman
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Principal Investigator:
          • Ida Micaily
      • Philadelphia, Pennsylvania, United States, 19114
        • Recruiting
        • Jefferson Torresdale Hospital
        • Contact:
        • Principal Investigator:
          • Ida Micaily
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Pittsburgh, Pennsylvania, United States, 15215
        • Recruiting
        • UPMC-Saint Margaret
        • Contact:
          • Site Public Contact
          • Phone Number: 412-784-4900
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Pittsburgh, Pennsylvania, United States, 15237
        • Recruiting
        • UPMC-Passavant Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-367-6454
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Pittsburgh, Pennsylvania, United States, 15243
        • Recruiting
        • UPMC-Saint Clair Hospital Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 412-502-3920
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Pittsburgh, Pennsylvania, United States, 15224
        • Active, not recruiting
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, United States, 15212
        • Active, not recruiting
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC-Shadyside Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 412-621-2334
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Sayre, Pennsylvania, United States, 18840
        • Recruiting
        • Guthrie Medical Group PC-Robert Packer Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 800-836-0388
        • Principal Investigator:
          • Joyson Poulose
      • Washington, Pennsylvania, United States, 15301
        • Recruiting
        • UPMC Cancer Center-Washington
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Washington, Pennsylvania, United States, 15301
        • Recruiting
        • UPMC Washington Hospital Radiation Oncology
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Wexford, Pennsylvania, United States, 15090
        • Active, not recruiting
        • Wexford Health and Wellness Pavilion
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Williamsport, Pennsylvania, United States, 17754
        • Recruiting
        • Divine Providence Hospital
        • Contact:
        • Principal Investigator:
          • Uzoma K. Iheagwara
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Contact:
        • Principal Investigator:
          • Paul B. Gilman
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health-York Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
        • Principal Investigator:
          • Sherif F. Yacoub
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health-York Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
        • Principal Investigator:
          • Sherif F. Yacoub
      • York, Pennsylvania, United States, 17408
        • Recruiting
        • UPMC Memorial
        • Contact:
          • Site Public Contact
          • Phone Number: 717-724-6760
        • Principal Investigator:
          • Uzoma K. Iheagwara
    • Rhode Island
      • Westerly, Rhode Island, United States, 02891
        • Recruiting
        • Smilow Cancer Hospital Care Center - Westerly
        • Contact:
        • Principal Investigator:
          • Henry S. Park
    • South Carolina
      • Bluffton, South Carolina, United States, 29910
        • Active, not recruiting
        • Saint Joseph's/Candler - Bluffton Campus
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Mariam Alexander
      • Gaffney, South Carolina, United States, 29341
        • Suspended
        • Gibbs Cancer Center-Gaffney
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • Saint Francis Hospital
        • Contact:
        • Principal Investigator:
          • Alex X. Yang
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Saint Francis Cancer Center
        • Contact:
        • Principal Investigator:
          • Alex X. Yang
      • Greenville, South Carolina, United States, 29605
        • Active, not recruiting
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, United States, 29615
        • Active, not recruiting
        • Prisma Health Cancer Institute - Eastside
      • Greenwood, South Carolina, United States, 29646
        • Recruiting
        • Self Regional Healthcare
        • Principal Investigator:
          • Mariam Alexander
        • Contact:
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Greer, South Carolina, United States, 29650
        • Active, not recruiting
        • Prisma Health Cancer Institute - Greer
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Levine Cancer Institute-Rock Hill
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • Benjamin J. Moeller
      • Rock Hill, South Carolina, United States, 29730
        • Recruiting
        • Rock Hill Radiation Therapy Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • John H. Heinzerling
      • Seneca, South Carolina, United States, 29672
        • Active, not recruiting
        • Prisma Health Cancer Institute - Seneca
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Union, South Carolina, United States, 29379
        • Suspended
        • MGC Hematology Oncology-Union
    • South Dakota
      • Pierre, South Dakota, United States, 57501
        • Recruiting
        • Avera Cancer Institute at Pierre
        • Contact:
        • Principal Investigator:
          • Benjamin M. Solomon
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
        • Principal Investigator:
          • Benjamin M. Solomon
      • Yankton, South Dakota, United States, 57078
        • Recruiting
        • Avera Cancer Institute at Yankton
        • Contact:
        • Principal Investigator:
          • Benjamin M. Solomon
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Contact:
        • Principal Investigator:
          • Philip E. Lammers
    • Texas
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Contact:
        • Principal Investigator:
          • Saumil Gandhi
      • Flower Mound, Texas, United States, 75028
        • Suspended
        • Texas Oncology-Flower Mound
      • Fort Worth, Texas, United States, 76104
        • Suspended
        • Texas Oncology - Fort Worth Cancer Center
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Saumil Gandhi
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Contact:
        • Principal Investigator:
          • Saumil Gandhi
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Contact:
        • Principal Investigator:
          • Saumil Gandhi
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Texas Oncology-McKinney
        • Principal Investigator:
          • David A. Buck
        • Contact:
          • Site Public Contact
          • Phone Number: 972-542-8609
      • Plano, Texas, United States, 75093
        • Suspended
        • Texas Oncology-Plano West
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Contact:
        • Principal Investigator:
          • Saumil Gandhi
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Texas Oncology Cancer Center Sugar Land
        • Contact:
          • Site Public Contact
          • Phone Number: 281-277-5200
        • Principal Investigator:
          • David A. Buck
      • The Woodlands, Texas, United States, 77380
        • Recruiting
        • Texas Oncology-The Woodlands
        • Contact:
          • Site Public Contact
          • Phone Number: 888-864-4226
        • Principal Investigator:
          • David A. Buck
    • Utah
      • Farmington, Utah, United States, 84025
        • Active, not recruiting
        • Farmington Health Center
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Kristine E. Kokeny
      • Salt Lake City, Utah, United States, 84106
        • Suspended
        • University of Utah Sugarhouse Health Center
    • Vermont
      • Berlin, Vermont, United States, 05602
        • Recruiting
        • Central Vermont Medical Center/National Life Cancer Treatment
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 802-225-5400
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Principal Investigator:
          • Nataniel H. Lester-Coll
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
      • Saint Johnsbury, Vermont, United States, 05819
        • Recruiting
        • Dartmouth Cancer Center - North
        • Contact:
        • Principal Investigator:
          • Alexander D. Fuld
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • Inova Schar Cancer Institute
        • Contact:
        • Principal Investigator:
          • Christopher B. Johnson
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Contact:
        • Principal Investigator:
          • Elisabeth Weiss
      • Richmond, Virginia, United States, 23298
        • Active, not recruiting
        • Virginia Commonwealth University/Massey Cancer Center
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Oncology and Hematology Associates of Southwest Virginia
        • Contact:
        • Principal Investigator:
          • David A. Buck
    • Washington
      • Bellingham, Washington, United States, 98225
        • Suspended
        • PeaceHealth Saint Joseph Medical Center
      • Silverdale, Washington, United States, 98383
      • Vancouver, Washington, United States, 98686
        • Active, not recruiting
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, United States, 98684
        • Active, not recruiting
        • Legacy Cancer Institute Medical Oncology and Day Treatment
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Recruiting
        • West Virginia University Charleston Division
        • Contact:
          • Site Public Contact
          • Phone Number: 304-388-9944
        • Principal Investigator:
          • Ahmed A. Khalid
      • Wheeling, West Virginia, United States, 26003
        • Recruiting
        • Wheeling Hospital/Schiffler Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 304-243-6442
        • Principal Investigator:
          • Jondavid Pollock
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Christopher S. Platta
      • Eau Claire, Wisconsin, United States, 54701
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Collin D. Driscoll
      • La Crosse, Wisconsin, United States, 54601
        • Withdrawn
        • Mayo Clinic Health System-Franciscan Healthcare
      • Marshfield, Wisconsin, United States, 54449
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Principal Investigator:
          • Jonathan R. Thompson
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Jonathan R. Thompson
      • Minocqua, Wisconsin, United States, 54548
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Principal Investigator:
          • Jonathan R. Thompson
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
      • Rhinelander, Wisconsin, United States, 54501
        • Recruiting
        • Aspirus Cancer Care - James Beck Cancer Center
        • Contact:
        • Principal Investigator:
          • Christopher S. Platta
      • Rice Lake, Wisconsin, United States, 54868
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Stevens Point, Wisconsin, United States, 54482
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Aspirus Cancer Care - Stevens Point
        • Contact:
        • Principal Investigator:
          • Christopher S. Platta
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
        • Principal Investigator:
          • Christopher S. Platta
      • West Bend, Wisconsin, United States, 53095
        • Recruiting
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Principal Investigator:
          • Jonathan R. Thompson
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718
        • Principal Investigator:
          • Christopher S. Platta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases

  • Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans (positron emission tomography [PET]/computed tomography [CT] scan, diagnostic CT scan, magnetic resonance imaging [MRI] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide/platinum (if not receiving PCI) or 6 weeks from completion of prophylactic cranial irradiation (PCI)

    • NOTE: Patients must have at least 3 cycles of E/P plus atezolizumab. They can have one cycle of induction E/P without concurrent atezolizumab if unable to receive concurrent E/P combined with atezolizumab for all cycles of induction therapy
  • Patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment
  • At time of enrollment after induction E/P chemotherapy and atezolizumab, if there is a pleural effusion, patients will be eligible if thoracentesis is cytologically negative or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging

  • Appropriate stage for study entry based on the following diagnostic workup:

    • History/physical examination within 14 days prior to registration;

    • Imaging within 42 days prior to registration to include:

      • MRI brain with contrast or CT brain with contrast
      • CT chest, abdomen and pelvis or whole body PET/CT scan any time after the fourth cycle of chemotherapy and prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,000/cells/mm^3 (within 14 days prior to registration)
  • Platelets >= 75,000 cells/mm^3 (within 14 days prior to registration)
  • Hemoglobin >= 8 g/dL (within 14 days prior to registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN (AST and/or ALT =< 5 ULN for patients with liver involvement) (within 14 days prior to registration)
  • Alkaline phosphatase =< 2.5 x ULN (=< 5 ULN for patients with documented liver involvement or bone metastases) (within 14 days prior to registration)
  • Adequate renal function = Creatinine clearance >=40 mL/min by the Cockcroft-Gault (C-G) equation: (within 14 days prior to registration)
  • Upfront radiation therapy of symptomatic metastatic site is permissible if causing symptoms such as pain or impending fracture
  • Patients with brain metastases are eligible after receiving whole brain radiation before enrollment (anytime during induction systemic therapy). Whole brain radiation can be delivered with hippocampal sparing or 3-D conformal technique. Patients with irradiated brain metastases are eligible if they are clinically stable from a neurological standpoint after completing radiotherapy (e.g. not having uncontrolled seizures) and do not require use of steroids above a dose of 10 mg of prednisone daily

  • For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to registration.

    • Note: Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:

      • Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
      • Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
  • Patients positive for human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months and a stable regimen of highly active anti-retroviral (HAART) HIV-positive patients must have no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Exclusion Criteria:

  • Metastatic disease invading the liver (> 3 metastases), heart or > 10 metastatic sites detectable after induction systemic therapy. Each visible bone metastasis on radiographic scan counts as one site
  • Patients with a concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen with atezolizumab or radiation
  • Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet acceptable dose constraints for normal tissue

  • Active autoimmune disease, including, but not limited to: systemic lupus erythematosus; rheumatoid arthritis; inflammatory bowel disease (e.g. Crohn's, ulcerative colitis); vascular thrombosis associated with antiphospholipid syndrome; Wegener's granulomatosis; Sjogren's syndrome; Guillain-Barre syndrome; multiple sclerosis; vasculitis; or glomerulonephritis.

    • If the autoimmune disease is not active for over 3 years and the patient is not receiving immunosuppressive treatment such as methotrexate or steroids above a dose equivalent to 10 mg prednisone daily, the patient is eligible.
    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
    • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations are excluded only if they have active disease with acute exacerbation and on immunosuppressive medications within the 12 months prior to enrollment. They are eligible otherwise.

  • Severe, active co-morbidity defined as follows:

    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
    • Active tuberculosis;

    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease

      • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible
      • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test)
    • Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL);
    • Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary;
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months;
    • History of recent myocardial infarction within 6 months prior to registration.
    • Clinically significant interstitial lung disease
  • Pregnancy: Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Women who are breastfeeding and unwilling to discontinue
  • History of allogeneic organ transplant
  • Patients who have had immunotherapy-induced pneumonitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm I (atezolizumab)
Patients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Positron Emission Tomography
Undergo PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Drug: Atezolizumab
Given IV
Other Names:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL328OA
  • RG-7446
  • RG 7446
  • RO 5541267
  • RO-5541267
Procedure: Biospecimen Collection
Undergo blood and tissue collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Experimental: Arm II (atezolizumab, radiation therapy)
Patients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-5 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Radiation: Radiation Therapy
Undergo radiation therapy
Other Names:
  • Cancer Radiotherapy
  • ENERGY_TYPE
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiation
  • Radiation Therapy, NOS
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • Energy Type
Procedure: Positron Emission Tomography
Undergo PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
  • PT
  • Positron emission tomography (procedure)
Drug: Atezolizumab
Given IV
Other Names:
  • Tecentriq
  • MPDL3280A
  • RO5541267
  • RG7446
  • MPDL 3280A
  • MPDL 328OA
  • MPDL-3280A
  • MPDL328OA
  • RG-7446
  • RG 7446
  • RO 5541267
  • RO-5541267
Procedure: Biospecimen Collection
Undergo blood and tissue collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS) (Phase II)
Time Frame: From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 6 years
Will compare the distributions of PFS between treatment arms using a one-sided stratified log-rank test in all randomized eligible patients. The rates at various timepoints (e.g., every 6 months after randomization) and medians of PFS for each arm will be estimated using the Kaplan-Meier method. The associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Results from an unstratified analysis will also be provided.
From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 6 years
Overall survival (OS) (Phase III)
Time Frame: From randomization to the date of death due to any cause, assessed up to 6 years
Will compare arm I to arm 2 based on OS using a stratified log-rank test. Hazard ratios will be estimated using a stratified Cox regression model. Event rates over time will be estimated within each treatment group using the Kaplan-Meier method.
From randomization to the date of death due to any cause, assessed up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 6 years
For each patient, the maximum severity reported for both immune mediated and non-immune mediated adverse events will be used in the summaries. Adverse events will be summarized regardless of relationship to protocol treatment as assessed by the investigator. All adverse events, adverse events leading to withdrawal, interruption or modification of protocol treatment, grade >= 3 adverse events, and serious adverse events will be summarized. Deaths and cause of death will be summarized. The rate of treatment-related adverse events using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, version [v.]5.0) will be reported with the frequency and severity (e.g., type, grade, and attribution) by arm, the analysis will be performed at the time of both phase II and phase III (if applicable) primary endpoint analyses. All adverse events will be classified as either immune or non-immune mediated.
Up to 6 years
PFS (Phase III)
Time Frame: Up to 6 years
Assessed per Response Evaluation Criteria in Solid Tumors (RECIST). Will compare the distributions of PFS between treatment arms using a one-sided stratified log-rank test in all randomized eligible patients at 0.025 level. The rates at various timepoints (e.g., every 6 months after randomization) and medians of PFS for each arm will be estimated using the Kaplan-Meier method. The associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. If one stratum has less than 10 events, the stratification factor which contains the level with the smallest number of patients will be removed from the stratified analyses.
Up to 6 years
PFS in patients with 1-3 distinct visible tumors and > 3 distinct visible tumors
Time Frame: Up to 6 years
Will be similarly summarized and compared between experimental and control. The interaction between the treatment groups and tumor number groups will also be explored in Cox regression model.
Up to 6 years
OS in patients with 1-3 distinct visible tumors and > 3 distinct visible tumors
Time Frame: Up to 6 years
Will be similarly summarized and compared between experimental and control. The interaction between the treatment groups and tumor number groups will also be explored in Cox regression model.
Up to 6 years
PFS in patients receiving consolidation radiotherapy to all visible disease and patients who do not receive consolidation radiotherapy to all visible disease
Time Frame: Up to 6 years
Up to 6 years
OS in patients receiving consolidation radiotherapy to all visible disease and patients who do not receive consolidation radiotherapy to all visible disease
Time Frame: Up to 6 years
Up to 6 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor burden
Time Frame: Up to 6 years
Tumor burden determined by central radiographic assessment, using both tumor number and tumor volume will be associated with PFS and OS benefit. The PFS and OS will be similarly summarized and compared between experimental and control in the following subgroups: 1) high or low tumor burden, using >= 4, 5, or 6 metastases as a cutoff; 2) high or low tumor burden, using the median of centrally reviewed radiographic tumor volume as a cutoff.
Up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

NRG Oncology

Investigators

  • Principal Investigator: Quynh-Nhu Nguyen, NRG Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2021

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

April 30, 2027

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

May 22, 2020

First Posted (Actual)

May 27, 2020

Study Record Updates

Last Update Posted (Estimated)

January 17, 2025

Last Update Submitted That Met QC Criteria

January 16, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2020-03472 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NRG-LU007 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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