Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer

February 5, 2024 updated by: NRG Oncology

Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally Advanced Non-Small Cell Lung Cancer

This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy [IGRT] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Standard chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with inoperable non-small cell lung cancer than giving the standard treatment alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To compare the overall survival in patients with stage II-IIIC inoperable node-positive non-small cell lung cancer (NSCLC) after image guided, motion-managed conventional radiotherapy to the primary tumor and nodal metastases (arm 1) or after image guided, motion-managed stereotactic body radiation therapy (SBRT) to the primary tumor followed by conventionally fractionated radiotherapy to nodal metastases (arm 2) both given with concurrent platinum-based chemotherapy.

II. To compare progression-free survival between the experimental arm (arm 2) and control arm (arm 1).

SECONDARY OBJECTIVES:

I. To compare objective response rate (as defined by Response Evaluation Criteria in Solid Tumors [RECIST] version [v] 1.1) between the experimental arm and control arm.

II. To compare the rate of local control between the experimental arm and control arm.

III. To compare patterns of failure (primary, locoregional, or distant) between the experimental arm and control arm.

IV. To compare changes in pulmonary function (forced expiratory volume in 1 second [FEV1] and diffusion capacity of the lung for carbon monoxide [DLCO] assessed at randomization and at 6 and 12 months following completion of radiation therapy) between the experimental arm and control arm.

V. To compare changes in quality of life and patient-reported outcomes assessed from pre-treatment to 3 months following radiation therapy of each treatment arm.

VI. To determine acute and late toxicity profiles of each treatment arm as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v5.

EXPLORATORY OBJECTIVES:

I. To characterize and compare longitudinal quality of life and patient-reported outcomes of each treatment arm.

II. To collect biospecimens at baseline, after SBRT (for arm 2 patients), during last 2 weeks of chemoradiation, and after first dose of consolidation therapy, to allow for future analyses.

III. To collect 4-dimensional (4D) computed tomography (CT) planning scans and radiation dose to calculate regional lung ventilation and explore pre-treatment 4D-CT based ventilation to predict pulmonary toxicity.

IV. To characterize clinical outcomes, toxicities and changes in pulmonary function and quality of life among patients receiving proton and photon radiotherapy.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel intravenously (IV) and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or positron emission tomography (PET)/CT during follow up.

ARM II: Patients undergo SBRT and conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.

Study Type

Interventional

Enrollment (Estimated)

474

Phase

  • 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
    • Arizona
      • Phoenix, Arizona, United States, 85004
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • Banner University Medical Center - Tucson
        • Contact:
        • Principal Investigator:
          • Charles C. Hsu
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-North Campus
        • Contact:
        • Principal Investigator:
          • Charles C. Hsu
    • California
      • Bakersfield, California, United States, 93301
        • Recruiting
        • AIS Cancer Center at San Joaquin Community Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 661-323-4673
        • Principal Investigator:
          • Luis Mariscal
      • Burlingame, California, United States, 94010
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 323-865-0451
        • Principal Investigator:
          • Jason C. Ye
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Los Angeles General Medical Center
        • Principal Investigator:
          • Jason C. Ye
        • Contact:
      • Marysville, California, United States, 95901
        • Recruiting
        • Fremont - Rideout Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 530-749-4400
        • Principal Investigator:
          • Edward J. Kim
      • Roseville, California, United States, 95661
        • Recruiting
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
      • Roseville, California, United States, 95661
      • Sacramento, California, United States, 95816
      • San Francisco, California, United States, 94115
        • Recruiting
        • California Pacific Medical Center-Pacific Campus
        • Principal Investigator:
          • Christopher U. Jones
        • Contact:
      • San Mateo, California, United States, 94401
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • UCHealth University of Colorado Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
        • Principal Investigator:
          • Brian D. Kavanagh
      • Colorado Springs, Colorado, United States, 80909
        • Recruiting
        • UCHealth Memorial Hospital Central
        • Contact:
          • Site Public Contact
          • Phone Number: 719-365-2406
        • Principal Investigator:
          • Brian D. Kavanagh
      • Colorado Springs, Colorado, United States, 80920
        • Recruiting
        • Memorial Hospital North
        • Contact:
          • Site Public Contact
          • Phone Number: 719-364-6700
        • Principal Investigator:
          • Brian D. Kavanagh
      • Colorado Springs, Colorado, United States, 80907
        • Recruiting
        • Rocky Mountain Cancer Centers-Penrose
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Denver, Colorado, United States, 80206
        • Recruiting
        • UCHealth - Cherry Creek
        • Contact:
        • Principal Investigator:
          • Brian D. Kavanagh
      • Fort Collins, Colorado, United States, 80524
        • Recruiting
        • Poudre Valley Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 970-297-6150
        • Principal Investigator:
          • Brian D. Kavanagh
      • Fort Collins, Colorado, United States, 80528
        • Recruiting
        • Cancer Care and Hematology-Fort Collins
        • Contact:
        • Principal Investigator:
          • Brian D. Kavanagh
      • Greeley, Colorado, United States, 80631
        • Recruiting
        • UCHealth Greeley Hospital
        • Contact:
        • Principal Investigator:
          • Brian D. Kavanagh
      • Highlands Ranch, Colorado, United States, 80129
        • Recruiting
        • UCHealth Highlands Ranch Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
        • Principal Investigator:
          • Brian D. Kavanagh
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • UCHealth Lone Tree Health Center
        • Contact:
        • Principal Investigator:
          • Brian D. Kavanagh
      • Loveland, Colorado, United States, 80538
        • Recruiting
        • Medical Center of the Rockies
        • Contact:
          • Site Public Contact
          • Phone Number: 970-203-7083
        • Principal Investigator:
          • Brian D. Kavanagh
    • Delaware
      • 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:
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System-Christiana Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Morton Plant Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 855-314-8646
        • Principal Investigator:
          • Vijaya K. Gadiyaram
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Aparna Kesarwala
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
          • Site Public Contact
          • Phone Number: 404-489-9164
        • Principal Investigator:
          • Aparna Kesarwala
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Aparna Kesarwala
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Aparna Kesarwala
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory Proton Therapy Center
        • Contact:
        • Principal Investigator:
          • Aparna Kesarwala
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Recruiting
        • Pali Momi Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-486-6000
        • Principal Investigator:
          • Michael C. Roach
      • 'Aiea, Hawaii, United States, 96701
        • Recruiting
        • Hawaii Cancer Care - Westridge
        • Contact:
        • Principal Investigator:
          • Michael C. Roach
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Hawaii Cancer Care Inc - Waterfront Plaza
        • Contact:
        • Principal Investigator:
          • Michael C. Roach
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Cancer Cenrer - POB I
        • Contact:
          • Site Public Contact
          • Phone Number: 808-532-0315
        • Principal Investigator:
          • Michael C. Roach
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-545-8548
        • Principal Investigator:
          • Michael C. Roach
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Straub Clinic and Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 808-522-4333
        • Principal Investigator:
          • Michael C. Roach
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • University of Hawaii Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-586-2979
        • Principal Investigator:
          • Michael C. Roach
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Kuakini Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 808-547-9816
        • Principal Investigator:
          • Michael C. Roach
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Queen's Cancer Center - Kuakini
        • Contact:
          • Site Public Contact
          • Phone Number: 808-531-8521
        • Principal Investigator:
          • Michael C. Roach
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • The Cancer Center of Hawaii-Liliha
        • Contact:
          • Site Public Contact
          • Phone Number: 808-547-6881
        • Principal Investigator:
          • Michael C. Roach
    • Illinois
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Barrington, Illinois, United States, 60010
        • Recruiting
        • Advocate Good Shepherd Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-842-4847
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Bloomington, Illinois, United States, 61701
        • Recruiting
        • Saint Joseph Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Mohamed E. Abazeed
        • Contact:
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 773-296-5360
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Crystal Lake, Illinois, United States, 60014
        • Recruiting
        • AMG Crystal Lake - Oncology
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Principal Investigator:
          • Mohamed E. Abazeed
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • 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:
      • Elgin, Illinois, United States, 60123
        • Recruiting
        • Advocate Sherman Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-429-2907
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Geneva, Illinois, United States, 60134
        • Recruiting
        • Northwestern Medicine Cancer Center Delnor
        • Principal Investigator:
          • Mohamed E. Abazeed
        • Contact:
      • Hazel Crest, Illinois, United States, 60429
        • Recruiting
        • Advocate South Suburban Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 708-799-9995
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • AMG Libertyville - Oncology
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Libertyville, Illinois, United States, 60048
        • Recruiting
        • Condell Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Oak Lawn, Illinois, United States, 60453-2699
        • Recruiting
        • Advocate Christ Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-323-8622
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-384-3621
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Methodist Medical Center of Illinois
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Memorial Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Sinisa Stanic
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Principal Investigator:
          • Mohamed E. Abazeed
        • Contact:
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Ankeny, Iowa, United States, 50023
        • Recruiting
        • Mission Cancer and Blood - Ankeny
        • Principal Investigator:
          • Richard L. Deming
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2921
      • Clive, Iowa, United States, 50325
        • Recruiting
        • Medical Oncology and Hematology Associates-West Des Moines
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Medical Oncology and Hematology Associates-Des Moines
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Mission Cancer and Blood - Laurel
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
        • Principal Investigator:
          • Richard L. Deming
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Ascension Via Christi Hospitals Wichita
        • Contact:
        • Principal Investigator:
          • Dennis F. Moore
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky/Markey Cancer Center
        • Principal Investigator:
          • Ronald C. McGarry
        • Contact:
          • Site Public Contact
          • Phone Number: 859-257-3379
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Anne Arundel Medical Center
        • Principal Investigator:
          • Amar Rewari
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
      • Bay City, Michigan, United States, 48706
        • Recruiting
        • McLaren Cancer Institute-Bay City
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Brighton, Michigan, United States, 48114
      • Brighton, Michigan, United States, 48114
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Chelsea, Michigan, United States, 48118
      • Chelsea, Michigan, United States, 48118
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • 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, 48532
        • Recruiting
        • McLaren Cancer Institute-Flint
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • Sparrow Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 517-364-9400
        • Principal Investigator:
          • Samir Narayan
      • Lansing, Michigan, United States, 48910
        • Recruiting
        • Karmanos Cancer Institute at McLaren Greater Lansing
        • Principal Investigator:
          • Brian K. Yeh
        • 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:
          • Samir Narayan
      • Mount Clemens, Michigan, United States, 48043
        • Recruiting
        • McLaren Cancer Institute-Macomb
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Petoskey, Michigan, United States, 49770
        • Recruiting
        • McLaren Cancer Institute-Northern Michigan
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Pontiac, Michigan, United States, 48341
        • Recruiting
        • 21st Century Oncology-Pontiac
        • Contact:
        • Principal Investigator:
          • Samir Narayan
      • Pontiac, Michigan, United States, 48341
      • Port Huron, Michigan, United States, 48060
        • Recruiting
        • McLaren-Port Huron
        • Principal Investigator:
          • Brian K. Yeh
        • Contact:
      • Royal Oak, Michigan, United States, 48073
        • Recruiting
        • William Beaumont Hospital-Royal Oak
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
        • Principal Investigator:
          • Inga S. Grills
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Troy, Michigan, United States, 48085
        • Recruiting
        • William Beaumont Hospital - Troy
        • Contact:
          • Site Public Contact
          • Phone Number: 248-551-7695
        • Principal Investigator:
          • Inga S. Grills
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contact:
        • Principal Investigator:
          • Samir Narayan
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Principal Investigator:
          • Donald J. Jurgens
    • 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
      • 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
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • 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
    • 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:
          • Gregory A. Russo
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Jacob Shin
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Jacob Shin
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Jacob Shin
    • New York
      • Batavia, New York, United States, 14020
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Einstein Campus
        • Contact:
        • Principal Investigator:
          • Nitin Ohri
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Contact:
        • Principal Investigator:
          • Nitin Ohri
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center-Weiler Hospital
        • Contact:
        • Principal Investigator:
          • Nitin Ohri
      • Canandaigua, New York, United States, 14424
        • Recruiting
        • Sands Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 585-396-6161
        • Principal Investigator:
          • Yuhchyau Chen
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Jacob Shin
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Jacob Shin
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Jacob Shin
      • New York, New York, United States, 10035
        • Recruiting
        • New York Proton Center
        • Contact:
        • Principal Investigator:
          • Charles B. Simone
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Principal Investigator:
          • Yuhchyau Chen
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
      • Rochester, New York, United States, 14620
        • Recruiting
        • Highland Hospital
        • Principal Investigator:
          • Yuhchyau Chen
        • Contact:
          • Site Public Contact
          • Phone Number: 585-341-8113
      • Rochester, New York, United States, 14606
        • Recruiting
        • Wilmot Cancer Institute Radiation Oncology at Greece
        • Principal Investigator:
          • Yuhchyau Chen
        • Contact:
          • Site Public Contact
          • Phone Number: 585-758-7877
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Jacob Shin
      • Valhalla, New York, United States, 10595
        • Recruiting
        • Westchester Medical Center
        • Contact:
        • Principal Investigator:
          • Aviva Berkowitz
      • Webster, New York, United States, 14580
    • 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:
          • John H. Heinzerling
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Carolinas Medical Center/Levine Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • John H. Heinzerling
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center
        • Principal Investigator:
          • Kevin S. Roof
        • Contact:
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • Atrium Health Pineville/LCI-Pineville
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
        • Principal Investigator:
          • John H. Heinzerling
      • Charlotte, North Carolina, United States, 28262
        • Recruiting
        • Atrium Health University City/LCI-University
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • John H. Heinzerling
      • Clemmons, North Carolina, United States, 27012
        • Recruiting
        • Wake Forest University at Clemmons
        • Contact:
          • Site Public Contact
          • Phone Number: 888-716-9259
        • Principal Investigator:
          • Michael K. Farris
      • Concord, North Carolina, United States, 28025
        • Recruiting
        • Atrium Health Cabarrus/LCI-Concord
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • John H. Heinzerling
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • CaroMont Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey G. Kuremsky
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Novant Health Cancer Institute - Huntersville
        • Principal Investigator:
          • Kevin S. Roof
        • Contact:
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Novant Health Presbyterian Medical Center Huntersville
        • Principal Investigator:
          • Kevin S. Roof
        • Contact:
      • Kernersville, North Carolina, United States, 27284
        • Recruiting
        • Novant Health Cancer Institute - Kernersville
        • Principal Investigator:
          • Volker W. Stieber
        • Contact:
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • Novant Health Cancer Institute - Matthews
        • Principal Investigator:
          • Kevin S. Roof
        • Contact:
      • 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
      • Matthews, North Carolina, United States, 28105
        • Recruiting
        • Matthews Radiation Oncology Center
        • Principal Investigator:
          • Kevin S. Roof
        • Contact:
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Atrium Health Union/LCI-Union
        • Contact:
          • Site Public Contact
          • Phone Number: 980-442-2000
        • Principal Investigator:
          • John H. Heinzerling
      • Mooresville, North Carolina, United States, 28117
        • Recruiting
        • Novant Health Cancer Institute - Mooresville
        • Principal Investigator:
          • Kevin S. Roof
        • Contact:
      • Mount Airy, North Carolina, United States, 27030
        • Recruiting
        • Novant Health Cancer Institute - Mount Airy
        • Principal Investigator:
          • Volker W. Stieber
        • Contact:
      • Salisbury, North Carolina, United States, 28144
        • Recruiting
        • Rowan Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Kevin S. Roof
      • Salisbury, North Carolina, United States, 28144
        • Recruiting
        • Novant Health Cancer Institute - Rowan
        • Principal Investigator:
          • Kevin S. Roof
        • Contact:
      • 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
      • Statesville, North Carolina, United States, 28625
        • Recruiting
        • Novant Health Cancer Institute - Statesville
        • Principal Investigator:
          • Volker W. Stieber
        • Contact:
      • Supply, North Carolina, United States, 28462
        • Recruiting
        • Novant Cancer Institute Radiation Oncology - Supply
        • Contact:
          • Site Public Contact
          • Phone Number: 910-754-4716
        • Principal Investigator:
          • Rex A. Kiteley
      • Thomasville, North Carolina, United States, 27360
        • Recruiting
        • Novant Health Cancer Institute - Thomasville
        • Principal Investigator:
          • Volker W. Stieber
        • Contact:
      • Wilkesboro, North Carolina, United States, 28659
        • Recruiting
        • Novant Health Cancer Institute - Wilkesboro
        • Principal Investigator:
          • Volker W. Stieber
        • Contact:
      • Wilkesboro, North Carolina, United States, 28659
        • Recruiting
        • Wake Forest Baptist Health - Wilkes Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-716-9253
        • Principal Investigator:
          • Michael K. Farris
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Novant Health New Hanover Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 910-342-3000
        • Principal Investigator:
          • Rex A. Kiteley
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Novant Health Cancer Institute Radiation Oncology - Wilmington
        • Contact:
          • Site Public Contact
          • Phone Number: 910-251-1839
        • Principal Investigator:
          • Rex A. Kiteley
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Michael K. Farris
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center
        • Principal Investigator:
          • Volker W. Stieber
        • Contact:
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58122
      • Grand Forks, North Dakota, United States, 58201
        • Recruiting
        • Altru Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 701-780-6520
        • Principal Investigator:
          • Grant R. Seeger
    • Ohio
      • Akron, Ohio, United States, 44307
        • Recruiting
        • Cleveland Clinic Akron General
        • Contact:
        • Principal Investigator:
          • Praveen Pendyala
      • Canton, Ohio, United States, 44708
        • Recruiting
        • Cleveland Clinic Mercy Hospital
        • Principal Investigator:
          • Edward J. Walsh
        • Contact:
          • Site Public Contact
          • Phone Number: 888-293-4673
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Miami Valley Hospital South
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Miami Valley Hospital
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Physician LLC-Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
      • Dayton, Ohio, United States, 45409
        • Recruiting
        • Dayton Blood and Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 937-276-8320
        • Principal Investigator:
          • Tarek M. Sabagh
      • 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
      • Perrysburg, Ohio, United States, 43551
        • Recruiting
        • Mercy Health Perrysburg Cancer Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Upper Valley Medical Center
        • Contact:
        • Principal Investigator:
          • Tarek M. Sabagh
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Raid Aljumaily
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Recruiting
        • Legacy Mount Hood Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Andrew Y. Kee
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Hospital and Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-220-4937
          • Email: cancer@lhs.org
        • Principal Investigator:
          • Andrew Y. Kee
      • Tualatin, Oregon, United States, 97062
        • Recruiting
        • Legacy Meridian Park Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-1742
        • Principal Investigator:
          • Andrew Y. Kee
    • Pennsylvania
      • 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
        • Principal Investigator:
          • Amit B. Shah
        • Contact:
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Ephrata, Pennsylvania, United States, 17522
        • Recruiting
        • Ephrata Cancer Center
        • Principal Investigator:
          • Amit B. Shah
        • Contact:
          • Site Public Contact
          • Phone Number: 717-721-4840
      • Gettysburg, Pennsylvania, United States, 17325
        • Recruiting
        • Adams Cancer Center
        • Principal Investigator:
          • Amit B. Shah
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
      • Lebanon, Pennsylvania, United States, 17042
        • Recruiting
        • Sechler Family Cancer Center
        • Principal Investigator:
          • Amit B. Shah
        • Contact:
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania/Abramson Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-474-9892
        • Principal Investigator:
          • Jeffrey D. Bradley
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Thomas Jefferson University Hospital
        • Contact:
        • Principal Investigator:
          • Maria Werner-Wasik
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 610-988-9323
        • Principal Investigator:
          • Michael L. Haas
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • Fiori Alite
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Asplundh Cancer Pavilion
        • Contact:
        • Principal Investigator:
          • Maria Werner-Wasik
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health-York Cancer Center
        • Principal Investigator:
          • Amit B. Shah
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Health-York Hospital
        • Principal Investigator:
          • Amit B. Shah
        • Contact:
          • Site Public Contact
          • Phone Number: 877-441-7957
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Recruiting
        • Levine Cancer Institute-Rock Hill
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-9376
        • Principal Investigator:
          • John H. Heinzerling
      • 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
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Texas
      • Conroe, Texas, United States, 77384
        • Recruiting
        • MD Anderson in The Woodlands
        • Contact:
        • Principal Investigator:
          • Julianna Bronk
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • Julianna Bronk
      • Houston, Texas, United States, 77079
        • Recruiting
        • MD Anderson West Houston
        • Contact:
        • Principal Investigator:
          • Julianna Bronk
      • League City, Texas, United States, 77573
        • Recruiting
        • MD Anderson League City
        • Contact:
        • Principal Investigator:
          • Julianna Bronk
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • MD Anderson in Sugar Land
        • Contact:
        • Principal Investigator:
          • Julianna Bronk
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-4101
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Christopher J. Anker
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont and State Agricultural College
        • Contact:
          • Site Public Contact
          • Phone Number: 802-656-8990
          • Email: rpo@uvm.edu
        • Principal Investigator:
          • Christopher J. Anker
      • Saint Johnsbury, Vermont, United States, 05819
        • Recruiting
        • Norris Cotton Cancer Center-North
        • Contact:
        • Principal Investigator:
          • Gregory A. Russo
    • Washington
      • Vancouver, Washington, United States, 98686
        • Recruiting
        • Legacy Salmon Creek Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Andrew Y. Kee
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Legacy Cancer Institute Medical Oncology and Day Treatment
        • Contact:
        • Principal Investigator:
          • Andrew Y. Kee
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Burlington, Wisconsin, United States, 53105
        • Recruiting
        • Aurora Cancer Care-Southern Lakes VLCC
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Eau Claire, Wisconsin, United States, 54701
        • Recruiting
        • HSHS Sacred Heart Hospital
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Germantown, Wisconsin, United States, 53022
        • Recruiting
        • Aurora Health Care Germantown Health Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Grafton, Wisconsin, United States, 53024
        • Recruiting
        • Aurora Cancer Care-Grafton
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Green Bay, Wisconsin, United States, 54311
        • Recruiting
        • Aurora BayCare Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Johnson Creek, Wisconsin, United States, 53038
        • Recruiting
        • UW Cancer Center Johnson Creek
        • Contact:
        • Principal Investigator:
          • Andrew M. Baschnagel
      • Kenosha, Wisconsin, United States, 53142
        • Recruiting
        • Aurora Cancer Care-Kenosha South
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-622-8922
        • Principal Investigator:
          • Andrew M. Baschnagel
      • Marinette, Wisconsin, United States, 54143
        • Recruiting
        • Aurora Bay Area Medical Group-Marinette
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
        • Principal Investigator:
          • Lindsay L. Puckett
      • Milwaukee, Wisconsin, United States, 53209
        • Recruiting
        • Aurora Cancer Care-Milwaukee
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Lindsay L. Puckett
      • Milwaukee, Wisconsin, United States, 53233
        • Recruiting
        • Aurora Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Milwaukee, Wisconsin, United States, 53295
        • Recruiting
        • Zablocki Veterans Administration Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-469-6614
        • Principal Investigator:
          • Adam D. Currey
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Lindsay L. Puckett
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • Vince Lombardi Cancer Clinic - Oshkosh
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Racine, Wisconsin, United States, 53406
        • Recruiting
        • Aurora Cancer Care-Racine
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Rhinelander, Wisconsin, United States, 54501
        • Recruiting
        • Ascension Saint Mary's Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Vince Lombardi Cancer Clinic-Sheboygan
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Ascension Saint Michael's Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Contact:
        • Principal Investigator:
          • Matthew L. Ryan
      • Summit, Wisconsin, United States, 53066
        • Recruiting
        • Aurora Medical Center in Summit
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Wauwatosa, Wisconsin, United States, 53226
        • Recruiting
        • Aurora Cancer Care-Milwaukee West
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
        • Principal Investigator:
          • Jeffrey A. Kittel
      • West Bend, Wisconsin, United States, 53095
        • Recruiting
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Lindsay L. Puckett
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of stage II or III (American Joint Committee on Cancer [AJCC] eighth edition) non-small cell lung cancer (NSCLC) with known PD-L1 status prior to registration

    • Patients must have an identified primary tumor and at least one nodal metastasis (peribronchial/hilar/intrapulmonary, mediastinal/subcarinal, supraclavicular/scalene)
    • Up to 4 cycles of systemic therapy received prior to registration for the current study cancer is allowable; any prior chemotherapy for a different cancer is also permissible

  • The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments:

    • History/physical examination prior to registration;
    • Magnetic resonance imaging (MRI) scan of the brain (preferred) or CT scan of the brain (if available, contrast is preferred for all neuroimaging) prior to registration;
    • CT chest with IV contrast (if contrast is available and unless contraindicated, such as for abnormal kidney function) prior to registration. PET/CT may be used if the CT portion is of identical diagnostic quality as achieved in a stand-alone CT
  • No evidence of distant metastases based on FDG PET/CT scan obtain within 60 days of registration
  • Primary tumor =< 7 cm
  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Hematologic function (e.g. platelets, leukocytes, hemoglobin) amenable, at the discretion of the treating physician, to allow for treatment with chemotherapy and concurrent radiation therapy
  • Creatinine clearance >= 25 mL/min by the Cockcroft-Gault (C-G) equation

  • Subjects with non-malignant pleural effusion are eligible provided the effusion is not known or demonstrated to be an exudative effusion

    • If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:

      • When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative;
      • Effusions that are minimal (i.e., not visible on chest x-ray) that are too small to safely tap are eligible
  • Medical history consistent with the patient being amenable, at the discretion of the treating physician, to allow for treating with consolidation immunotherapy. Patients with known EGFR/ALK mutation at the time of registration are eligible, and these patients can be treated with consolidation durvalumab or chemotherapy at the discretion of the treating physician
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Negative pregnancy test =< 14 days prior to registration for participants of childbearing potential
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

Exclusion Criteria:

  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields that is determined by the treating physician to impede the treatment of the study malignancy
  • Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible (T3-4N0 or T0N1-3 patients are not eligible). At least 1 radiographically-involved lymph node is required, but pathologic confirmation of involvement is not mandated
  • Centrally located primary tumor < 2 cm from involved nodal disease which would result in significant overlap of the primary SBRT and nodal radiation fields. Centrally located is defined as within or touching the zone of the proximal bronchial tree, which is a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi)
  • Participants who are pregnant or unwilling to discontinue nursing
  • Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy and for the Food and Drug Administration (FDA)-labeled contraception timeframe required after the final dose of the selected chemotherapy regimen, because the treatment in this study may be significantly teratogenic

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 (image guided RT, chemotherapy, immunotherapy)
Patients undergo conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Cisplatin
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Biological: Durvalumab
Given IV
Other Names:
  • Imfinzi
  • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
  • MEDI-4736
  • MEDI4736
Drug: Pemetrexed
Given IV
Other Names:
  • MTA
  • Multitargeted Antifolate
  • Pemfexy
Radiation: Image Guided Radiation Therapy
Undergo IGRT
Other Names:
  • IGRT
  • image-guided radiation therapy
  • Image-Guided Radiotherapy
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Procedure: Computed Tomography
Undergo CT and/or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
Experimental: Arm II (SBRT, image guided RT, chemotherapy, immunotherapy)
Patients undergo SBRT and conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.
Drug: Carboplatin
Given IV
Other Names:
  • Blastocarb
  • Carboplat
  • Carboplatin Hexal
  • Carboplatino
  • Carboplatinum
  • Carbosin
  • Carbosol
  • Carbotec
  • CBDCA
  • Displata
  • Ercar
  • JM-8
  • Nealorin
  • Novoplatinum
  • Paraplatin
  • Paraplatin AQ
  • Paraplatine
  • Platinwas
  • Ribocarbo
Drug: Etoposide
Given IV
Other Names:
  • Demethyl Epipodophyllotoxin Ethylidine Glucoside
  • EPEG
  • Lastet
  • Toposar
  • Vepesid
  • VP 16
  • VP 16-213
  • VP-16
  • VP-16-213
  • VP16
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Drug: Cisplatin
Given IV
Other Names:
  • CDDP
  • Cis-diamminedichloridoplatinum
  • Cismaplat
  • Cisplatinum
  • Neoplatin
  • Platinol
  • Abiplatin
  • Blastolem
  • Briplatin
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cisplatina
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Drug: Paclitaxel
Given IV
Other Names:
  • Taxol
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol Konzentrat
Biological: Durvalumab
Given IV
Other Names:
  • Imfinzi
  • Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer
  • MEDI-4736
  • MEDI4736
Drug: Pemetrexed
Given IV
Other Names:
  • MTA
  • Multitargeted Antifolate
  • Pemfexy
Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SBRT
  • SABR
  • Stereotactic Ablative Body Radiation Therapy
Radiation: Image Guided Radiation Therapy
Undergo IGRT
Other Names:
  • IGRT
  • image-guided radiation therapy
  • Image-Guided Radiotherapy
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging
Procedure: Computed Tomography
Undergo CT and/or PET/CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Between date of randomization and date of death due to any cause, assessed up to 8 years
Non-inferiority (NI) between arm 2 and arm 1 (reference level) will be evaluated by comparing the upper bound of the 95% confidence interval for the hazard ratio to the pre-specified NI margin. NI of arm 2 will be concluded if the upper bound of the confidence interval is equal to, or falls below, the pre-specified margin at the final analysis. When evaluating the NI of arm 2 in OS, a Cox proportional hazards (PH) model stratified by stratification factors will be used to compute the hazard ratio and associated 95% confidence interval (CI). OS rates will be estimated using the Kaplan-Meier method. If the NI of arm 2 in OS is demonstrated, the superiority of arm 1 in OS will be tested at 1-sided significance level of 0.025 using a stratified log-rank test by adjusting for stratification factors.
Between date of randomization and date of death due to any cause, assessed up to 8 years
Progression-Free Survival (PFS)
Time Frame: Between date of randomization and first date of documented progression or death due to any cause, assessed up to 8 years
The PFS analysis will be conducted using the same methods and stratification factors as the OS analysis. The superiority of arm 2 in PFS will be tested at 1-sided significance level of 0.025 using a stratified log-rank test by adjusting for stratification factors. In the event that the NI of OS is not established, statistical inference of PFS will be considered exploratory in nature only. A Cox PH model stratified by stratification factors will be used to compute the hazard ratio and associated 95% CI.
Between date of randomization and first date of documented progression or death due to any cause, assessed up to 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 8 years
ORR (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) is defined as the number (%) of patients with at least 1 visit response of complete response (CR) or partial response (PR) and will be based on all randomized patients who have measurable disease. Therefore, data obtained up until progression, or the last evaluable assessment in the absence of progression, will be included in the assessment of ORR. The ORR will be compared between arm 2 versus arm 1 using a Fisher's exact test. A binary response variable for ORR will be used for the analysis with the categories of CR and PR versus stable disease (SD), progressive disease (PD) and inevaluable (NE).
Up to 8 years
Time to progression
Time Frame: Up to 8 years
Local control will be defined as freedom from local progression, in which a failure is defined as intrathoracic tumor progression (failure in the lobe of the primary tumor or mediastinal lymph nodes) by RECIST 1.1 criteria. Local control will be analyzed as competing risks data based on cause-specific hazards approaches, where deaths without local failure will be considered as a competing event and analyzed as "censoring" of local failure. 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. Results from an unstratified analysis will also be provided.
Up to 8 years
Time to primary, locoregional, or distant failure
Time Frame: Up to 8 years
Competing risks analysis will be used to analyze times to primary failure, locoregional failure and distant failure as the first failure. Competing events include primary failure, locoregional failure, distant failure and deaths without any failures. Rates at various timepoints (i.e., every 6 months after randomization) for each arm will be estimated using the cumulative incidence function. The associated 95% CI will be calculated using the Delta method and based on a log-log transformation applied on the estimated cumulative incidence functions. Statistical inferences of the development of each failure between arms will be based on cause-specific hazards using the log-rank test and Cox proportional hazard model. In addition, Gray's test and the Fine-Gray model will also be used to provide statistical inferences between arms based on cumulative incidence functions and subdistribution hazards.
Up to 8 years
Changes in pulmonary function
Time Frame: From randomization to 6 months or 12 months
Includes forced expiratory volume in 1 second (FEV1) and diffusion capacity of the lung for carbon monoxide (DLCO). Changes in pulmonary function (FEV1 and DLCO) will be summarized with descriptive statistics, and compared with Wilcoxon rank-sum test. The descriptive statistics of changes in FEV1 and diffusion capacity before and after treatment will be reported by treatment arm and by response categories (complete response; partial response; stable disease; progressive disease). Linear regression will be used to model changes with adjustment for treatment arms and possibly other baseline covariates, if applicable. The grade 3-5 NRG Oncology Pulmonary Toxicity Scale for changes will be reported with the frequency and grade by arm. Logistic regression will be used to model the distribution of the NRG Oncology Pulmonary Toxicity Scale by arms with and without adjustment for covariates.
From randomization to 6 months or 12 months
Patient Reported Outcomes
Time Frame: At 3, 12, and 24 months
Functional Assessment of Cancer Therapy Lung Questionnaire trial outcome index deterioration rates at 3 months and associated 95% confidence interval will be calculated for each treatment group, based on all randomized subjects. Clopper-Pearson method will be used for calculating 95% CI. The deterioration rates of each arm will also be compared using Cochran-Mantel-Haenszel Test, stratified by PD-L1 expression and T-stage.
At 3, 12, and 24 months
Incidence of adverse events
Time Frame: Up to 8 years
For each patient, the maximum severity reported will be used in the summaries. Adverse events will be summarized regardless of relationship to protocol treatment as assessed by the investigator. Treatment-related adverse events using National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) will be presented in statistical analysis reports/publications in CTCAE version 5. Adverse event rates will be reported with the frequency and severity (e.g., type, grade, and attribution) by arm.
Up to 8 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional mean lung dose
Time Frame: Up to 8 years
Collection of 4 dimensional (4D) CT planning CTs and calculation of radiation dose to regional lung ventilation will be performed among randomized patients with 4D CT planning CTs. To evaluate functional dose metrics, ventilation maps will be registered to the average 4DCT reference frame. Functional dose metrics and standard dose metrics will be calculated and evaluated. Functional mean lung dose will be defined as the mean dose delivered to functional lung. Dose to total lung and dose to functional lung will then be correlated with pulmonary toxicity including grade 2 or higher radiation pneumonitis or any grade 3 or higher cough, dyspnea, hypoxia or respiratory failure. Logistic regression models will be used to explore the correlation between pulmonary toxicity and functional mean lung dose.
Up to 8 years
Incidence of toxicities
Time Frame: Up to 8 years
Descriptive analyses will be reported, based on corresponding analysis plans within patients who actually receive proton and photon radiotherapy (e.g., per-protocol population), respectively.
Up to 8 years

Collaborators and Investigators

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

Sponsor

NRG Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Charles B Simone, 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)

May 10, 2023

Primary Completion (Estimated)

October 15, 2031

Study Completion (Estimated)

October 15, 2036

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 14, 2022

First Posted (Actual)

November 22, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRG-LU008 (Other Identifier: CTEP)
  • U10CA180868 (U.S. NIH Grant/Contract)
  • NCI-2022-08263 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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