Comparing Impact of Treatment Before or After Surgery in Patients With Stage II-IIIB Resectable Non-small Cell Lung Cancer

June 1, 2026 updated by: Alliance for Clinical Trials in Oncology

Perioperative Versus Adjuvant Systemic Therapy in Patients With Resectable Non-Small Cell Lung Cancer - PROSPECT LUNG

This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. 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. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVE:

I. To compare the 3-year real-world event-free survival (rwEFS) rate and overall survival (OS) between perioperative and adjuvant immunotherapy-based treatment for patients with resectable non-small cell lung cancer (dual endpoints).

SECONDARY OBJECTIVES:

I. To compare the rates of surgical resection between the two arms. II. To compare the rates of complete resection (R0) between the two arms. III. To summarize and compare rates of adverse events (AEs) resulting in permanent treatment discontinuation, hospitalization, or death between the two arms.

IV. To evaluate the association between locally defined pathological complete response (pCR) and rwEFS in patients randomized to the perioperative arm (arm 2).

V. To compare the rwEFS post 3-years from randomization between the two arms among patients who do not experience an event by 3 years.

EXPLORATORY OBJECTIVES:

I. To compare outcomes according to the systemic therapy administered on each arm.

II. To compare the sites of relapse between the two treatment arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1:

SURGERY: Patients undergo surgery within 28 days of registration.

ADJUVANT THERAPY: Patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles and immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines.

ARM 2:

NEOADJUVANT THERAPY: Within 28 days of registration, patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles in combination with immune checkpoint inhibitor (nivolumab, pembrolizumab, and/or atezolizumab) according to current approved guidelines.

SURGERY: Patients undergo surgery.

ADJUVANT THERAPY: Patients receive immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines.

Patients also undergo computed tomography (CT) throughout the study and may undergo magnetic resonance imaging (MRI) and/or positron emission tomography (PET)/CT at screening.

After completion of study treatment, patients are followed up every 6 months for up to 10 years.

Study Type

Interventional

Enrollment (Estimated)

1100

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 Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham Cancer Center
    • Arizona
      • Phoenix, Arizona, United States, 85004
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic Hospital in Arizona
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Dennis A. Wigle
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
        • Contact:
        • Principal Investigator:
          • Raymond U. Osarogiagbon
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • California
      • Antioch, California, United States, 94531
        • Active, not recruiting
        • Kaiser Permanente-Deer Valley Medical Center
      • Arroyo Grande, California, United States, 93420
      • Carmichael, California, United States, 95608
      • Carmichael, California, United States, 95608
      • Chico, California, United States, 95926
        • Recruiting
        • Enloe Medical Center
        • Principal Investigator:
          • Surbhi Singhal
        • Contact:
          • Site Public Contact
          • Phone Number: 530-332-4700
      • Dublin, California, United States, 94568
        • Active, not recruiting
        • Kaiser Permanente Dublin
      • Elk Grove, California, United States, 95758
      • Fremont, California, United States, 94538
        • Active, not recruiting
        • Kaiser Permanente-Fremont
      • Fresno, California, United States, 93720
        • Active, not recruiting
        • Kaiser Permanente-Fresno
      • Fresno, California, United States, 93720
        • Active, not recruiting
        • Fresno Cancer Center
      • Fresno, California, United States, 93720
        • Active, not recruiting
        • Kaiser Permanente Fresno Orchard Plaza
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
        • Principal Investigator:
          • Lyudmila A. Bazhenova
      • Marysville, California, United States, 95901
        • Recruiting
        • Fremont - Rideout Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 530-749-4400
        • Principal Investigator:
          • Surbhi Singhal
      • Merced, California, United States, 95340
      • Modesto, California, United States, 95356
        • Active, not recruiting
        • Kaiser Permanente-Modesto
      • Modesto, California, United States, 95356
        • Active, not recruiting
        • Kaiser Permanente- Modesto MOB II
      • Oakland, California, United States, 94611
        • Active, not recruiting
        • Kaiser Permanente Oakland-Broadway
      • Oakland, California, United States, 94611
        • Active, not recruiting
        • Kaiser Permanente-Oakland
      • Rancho Cordova, California, United States, 95670
        • Active, not recruiting
        • Kaiser Permanente-Rancho Cordova Cancer Center
      • Redwood City, California, United States, 94063
        • Active, not recruiting
        • Kaiser Permanente- Marshall Medical Offices
      • Richmond, California, United States, 94801
        • Active, not recruiting
        • Kaiser Permanente-Richmond
      • Rocklin, California, United States, 95765
      • Rohnert Park, California, United States, 94928
        • Active, not recruiting
        • Rohnert Park Cancer Center
      • Roseville, California, United States, 95678
        • Active, not recruiting
        • The Permanente Medical Group-Roseville Radiation Oncology
      • Roseville, California, United States, 95661
        • Active, not recruiting
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Comprehensive Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 916-734-3089
        • Principal Investigator:
          • Surbhi Singhal
      • Sacramento, California, United States, 95816
      • Sacramento, California, United States, 95823
        • Active, not recruiting
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, United States, 95823
        • Active, not recruiting
        • South Sacramento Cancer Center
      • Sacramento, California, United States, 95814
        • Active, not recruiting
        • Kaiser Permanente Downtown Commons
      • San Francisco, California, United States, 94115
        • Active, not recruiting
        • Kaiser Permanente-San Francisco
      • San Jose, California, United States, 95119
        • Active, not recruiting
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Active, not recruiting
        • Kaiser Permanente San Leandro
      • San Luis Obispo, California, United States, 93401
      • San Rafael, California, United States, 94903
        • Active, not recruiting
        • Kaiser San Rafael-Gallinas
      • Santa Clara, California, United States, 95051
        • Active, not recruiting
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Maria, California, United States, 93444
      • Santa Rosa, California, United States, 95403
        • Active, not recruiting
        • Kaiser Permanente-Santa Rosa
      • South San Francisco, California, United States, 94080
        • Active, not recruiting
        • Kaiser Permanente Cancer Treatment Center
      • South San Francisco, California, United States, 94080
        • Active, not recruiting
        • Kaiser Permanente-South San Francisco
      • Stockton, California, United States, 95204
        • Recruiting
        • Saint Joseph's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 209-461-5257
        • Principal Investigator:
          • Shahzad Siddique
      • Stockton, California, United States, 95210
        • Active, not recruiting
        • Kaiser Permanente-Stockton
      • Vacaville, California, United States, 95688
        • Active, not recruiting
        • Kaiser Permanente Medical Center-Vacaville
      • Vallejo, California, United States, 94589
        • Active, not recruiting
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Active, not recruiting
        • Kaiser Permanente-Walnut Creek
      • Woodland, California, United States, 95695
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs, Colorado, United States, 80923
      • Durango, Colorado, United States, 81301
      • Durango, Colorado, United States, 81301
      • Lakewood, Colorado, United States, 80228
      • Longmont, Colorado, United States, 80501
      • Pueblo, Colorado, United States, 81004
      • Westminster, Colorado, United States, 80023
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Recruiting
        • Beebe Medical Center
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • 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:
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Health System-Christiana Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Rehoboth Beach, Delaware, United States, 19971
        • Recruiting
        • Beebe Health Campus
        • Contact:
        • Principal Investigator:
          • Gregory A. Masters
      • Wilmington, Delaware, United States, 19801
        • Recruiting
        • Christiana Care Health System-Wilmington Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 202-444-2223
        • Principal Investigator:
          • Cristina Merkhofer
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital Center
        • Contact:
          • Site Public Contact
          • Phone Number: 202-877-8839
        • Principal Investigator:
          • Cristina Merkhofer
    • Florida
      • Lake Mary, Florida, United States, 32746
      • Lakeland, Florida, United States, 33805
        • Active, not recruiting
        • The Watson Clinic
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • Health Central
        • Contact:
        • Principal Investigator:
          • Jose E. Najera
      • Orlando, Florida, United States, 32806
    • Georgia
      • Newnan, Georgia, United States, 30265
        • Recruiting
        • CTCA at Southeastern Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 770-400-6629
        • Principal Investigator:
          • Debora S. Bruno
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Active, not recruiting
        • Kaiser Permanente Moanalua Medical Center
    • Idaho
      • Boise, Idaho, United States, 83706
        • Suspended
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, United States, 83605
        • Suspended
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Meridian, Idaho, United States, 83642
        • Suspended
        • Idaho Urologic Institute-Meridian
      • Nampa, Idaho, United States, 83687
        • Suspended
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Clinic Cancer Services - Sandpoint
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • OSF Saint Anthony's Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush-Copley Medical Center
        • Principal Investigator:
          • Tanmay Sahai
        • Contact:
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Memorial Hospital of Carbondale
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • 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:
      • Centralia, Illinois, United States, 62801
        • Suspended
        • Saint Mary's Hospital
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Divya M. Gupta
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • Frank Weinberg
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • John H Stroger Jr Hospital of Cook County
        • Contact:
          • Site Public Contact
          • Phone Number: 312-864-5204
        • Principal Investigator:
          • Deimante M. Tamkus
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • DeKalb, Illinois, United States, 60115
        • Recruiting
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contact:
        • Principal Investigator:
          • Divya M. Gupta
      • 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:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • 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
        • Contact:
        • Principal Investigator:
          • Divya M. Gupta
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • Northwestern Medicine Glenview Outpatient Center
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
        • Principal Investigator:
          • Divya M. Gupta
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Northwestern Medicine Grayslake Outpatient Center
        • Contact:
          • Site Public Contact
          • Phone Number: 312-695-1102
        • Principal Investigator:
          • Divya M. Gupta
      • Hines, Illinois, United States, 60141
        • Recruiting
        • Edward Hines Jr VA Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 708-202-8387
        • Principal Investigator:
          • Stanley J. Borowicz
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Lake Forest, Illinois, United States, 60045
        • Recruiting
        • Northwestern Medicine Lake Forest Hospital
        • Contact:
        • Principal Investigator:
          • Divya M. Gupta
      • 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:
          • Tanmay Sahai
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • SSM Health Good Samaritan
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • HSHS Saint Elizabeth's Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Oak Brook, Illinois, United States, 60523
      • Orland Park, Illinois, United States, 60462
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • 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
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Valley Radiation Oncology
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-664-4141
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Rockford, Illinois, United States, 61114
        • Recruiting
        • UW Health Carbone Cancer Center Rockford
        • Contact:
        • Principal Investigator:
          • Fahrettin Covut
      • Shiloh, Illinois, United States, 62269
        • Recruiting
        • Memorial Hospital East
        • Contact:
        • Principal Investigator:
          • Daniel Morgensztern
      • 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
        • Springfield Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Warrenville, Illinois, United States, 60555
        • Recruiting
        • Northwestern Medicine Cancer Center Warrenville
        • Contact:
        • Principal Investigator:
          • Divya M. Gupta
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Tanmay Sahai
      • Zion, Illinois, United States, 60099
        • Recruiting
        • Midwestern Regional Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 844-793-0745
        • Principal Investigator:
          • Ajaz M. Khan
    • Indiana
      • Goshen, Indiana, United States, 46526
        • Recruiting
        • Goshen Center for Cancer Care
        • Contact:
        • Principal Investigator:
          • James A. Wheeler
      • Richmond, Indiana, United States, 47374
        • Active, not recruiting
        • Reid Health
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Mercy Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 319-365-4673
        • Principal Investigator:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, United States, 52403
        • Recruiting
        • Oncology Associates at Mercy Medical Center
        • Principal Investigator:
          • Deborah W. Wilbur
        • Contact:
          • Site Public Contact
          • Phone Number: 319-363-2690
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Hays, Kansas, United States, 67601
        • Recruiting
        • HaysMed
        • Contact:
          • Site Public Contact
          • Phone Number: 785-623-5774
        • Principal Investigator:
          • Gary C. Doolittle
      • Lawrence, Kansas, United States, 66044
        • Recruiting
        • Lawrence Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Gary C. Doolittle
      • Olathe, Kansas, United States, 66061
        • Recruiting
        • The University of Kansas Cancer Center - Olathe
        • Principal Investigator:
          • Gary C. Doolittle
        • Contact:
      • Pittsburg, Kansas, United States, 66762
        • Recruiting
        • Mercy Hospital Pittsburg
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Salina, Kansas, United States, 67401
        • Recruiting
        • Salina Regional Health Center
        • Contact:
        • Principal Investigator:
          • Gary C. Doolittle
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • University of Kansas Health System Saint Francis Campus
        • Contact:
          • Site Public Contact
          • Phone Number: 785-295-8000
        • Principal Investigator:
          • Gary C. Doolittle
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • Recruiting
        • King's Daughter's Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 606-327-6499
        • Principal Investigator:
          • David K. Goebel
      • Bardstown, Kentucky, United States, 40004
      • Corbin, Kentucky, United States, 40701
      • Lexington, Kentucky, United States, 40509
      • Lexington, Kentucky, United States, 40504
      • Lexington, Kentucky, United States, 40504
      • London, Kentucky, United States, 40741
      • Mount Sterling, Kentucky, United States, 40353
      • Owensboro, Kentucky, United States, 42303
        • Recruiting
        • Owensboro Health Mitchell Memorial Cancer Center
        • Contact:
        • Principal Investigator:
          • Jewraj G. Maheshwari
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • University Medical Center New Orleans
        • Contact:
        • Principal Investigator:
          • Brian C. Boulmay
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University School of Medicine
        • Contact:
        • Principal Investigator:
          • Mark D. Sides
    • Maine
      • Bangor, Maine, United States, 04401
        • Recruiting
        • Eastern Maine Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 207-973-4274
        • Principal Investigator:
          • Sarah J. Sinclair
      • Brewer, Maine, United States, 04412
        • Recruiting
        • Lafayette Family Cancer Center-EMMC
        • Principal Investigator:
          • Sarah J. Sinclair
        • Contact:
          • Site Public Contact
          • Phone Number: 800-987-3005
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Recruiting
        • MedStar Franklin Square Medical Center/Weinberg Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 443-777-7364
        • Principal Investigator:
          • Cristina Merkhofer
      • Baltimore, Maryland, United States, 21239
        • Recruiting
        • MedStar Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Cristina Merkhofer
      • Elkton, Maryland, United States, 21921
        • Recruiting
        • Christiana Care - Union Hospital
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Recruiting
        • Beverly Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 2405 978-922-3000
        • Principal Investigator:
          • Fei Song
      • Boston, Massachusetts, United States, 02111
      • Burlington, Massachusetts, United States, 01805
      • Gloucester, Massachusetts, United States, 01930
        • Recruiting
        • Addison Gilbert Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 559 978-283-4000
        • Principal Investigator:
          • Fei Song
      • Peabody, Massachusetts, United States, 01960
      • Stoneham, Massachusetts, United States, 02180
        • Recruiting
        • Tufts Medical Center Cancer Center Stoneham
        • Principal Investigator:
          • Francis W. Nugent
        • Contact:
    • Michigan
      • Escanaba, Michigan, United States, 49829
        • Recruiting
        • OSF Saint Francis Hospital and Medical Group
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
    • Minnesota
      • Bemidji, Minnesota, United States, 56601
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Cambridge, Minnesota, United States, 55008
        • Recruiting
        • Cambridge Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Chaska, Minnesota, United States, 55318
        • Recruiting
        • Minnesota Oncology Hematology PA-Chaska
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Minnesota Oncology - Coon Rapids
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Minnesota Oncology - Edina
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Minnesota Oncology - Maple Grove
        • Principal Investigator:
          • Daniel M. Anderson
        • Contact:
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
        • Principal Investigator:
          • Dennis A. Wigle
      • Saint Cloud, Minnesota, United States, 56303
        • Recruiting
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contact:
        • Principal Investigator:
          • Donald J. Jurgens
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Thief River Falls, Minnesota, United States, 56701
        • Recruiting
        • Sanford Thief River Falls Medical Center
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Worthington, Minnesota, United States, 56187
        • Recruiting
        • Sanford Cancer Center Worthington
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
    • Mississippi
      • Columbus, Mississippi, United States, 39705
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Contact:
        • Principal Investigator:
          • Raymond U. Osarogiagbon
      • Grenada, Mississippi, United States, 38901
        • Recruiting
        • Baptist Cancer Center-Grenada
        • Contact:
        • Principal Investigator:
          • Raymond U. Osarogiagbon
      • New Albany, Mississippi, United States, 38652
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Union County
        • Contact:
        • Principal Investigator:
          • Raymond U. Osarogiagbon
      • Oxford, Mississippi, United States, 38655
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Oxford
        • Contact:
        • Principal Investigator:
          • Raymond U. Osarogiagbon
      • Southhaven, Mississippi, United States, 38671
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Contact:
        • Principal Investigator:
          • Raymond U. Osarogiagbon
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Mercy Oncology and Hematology - Clayton-Clarkson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • 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
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Mercy Cancer Center - Cape Girardeau
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • City of Saint Peters, Missouri, United States, 63376
        • Recruiting
        • Siteman Cancer Center at Saint Peters Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Morgensztern
      • Creve Coeur, Missouri, United States, 63141
        • Recruiting
        • Siteman Cancer Center at West County Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Morgensztern
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • University Health Truman Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 816-404-4375
        • Principal Investigator:
          • Gary C. Doolittle
      • Osage Beach, Missouri, United States, 65065
        • Recruiting
        • Lake Regional Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Phelps Health Delbert Day Cancer Institute
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • 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
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Daniel Morgensztern
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • St Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • St Louis, Missouri, United States, 63129
        • Recruiting
        • Siteman Cancer Center-South County
        • Contact:
        • Principal Investigator:
          • Daniel Morgensztern
      • St Louis, Missouri, United States, 63136
        • Recruiting
        • Siteman Cancer Center at Christian Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Morgensztern
      • St Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • St Louis, Missouri, United States, 63125
        • Recruiting
        • Veteran's Affairs Medical Center - Saint Louis
        • Principal Investigator:
          • Theodore S. Thomas
        • Contact:
      • St Louis, Missouri, United States, 63109
        • Recruiting
        • Mercy Infusion Center - Chippewa
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 888-446-3729
      • 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
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Health Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Great Falls Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Havre, Montana, United States, 59501
        • Recruiting
        • Hi-Line Sletten Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Helena, Montana, United States, 59601
        • Recruiting
        • Benefis Helena Specialty Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Logan Health Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
      • Kearney, Nebraska, United States, 68847
      • Omaha, Nebraska, United States, 68122
      • Omaha, Nebraska, United States, 68124
      • Omaha, Nebraska, United States, 68130
      • Omaha, Nebraska, United States, 68131
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contact:
        • Principal Investigator:
          • Dana M. Ferrari-Light
      • Manchester, New Hampshire, United States, 03104
        • Recruiting
        • Dartmouth Cancer Center - Manchester/ DCC Manchester
        • Contact:
          • Site Public Contact
          • Phone Number: 603-629-1828
        • Principal Investigator:
          • Dana M. Ferrari-Light
      • Nashua, New Hampshire, United States, 03063
        • Recruiting
        • Dartmouth Cancer Center - Nashua
        • Contact:
        • Principal Investigator:
          • Dana M. Ferrari-Light
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper Hospital University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 856-325-6757
        • Principal Investigator:
          • Veli Bakalov
      • Englewood, New Jersey, United States, 07631
        • Active, not recruiting
        • Englewood Hospital and Medical Center
      • Mount Laurel, New Jersey, United States, 08054
        • Recruiting
        • Cooper CyberKnife Center
        • Contact:
        • Principal Investigator:
          • Veli Bakalov
      • Neptune City, New Jersey, United States, 07753
        • Recruiting
        • Jersey Shore Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 732-776-4240
        • Principal Investigator:
          • Rachel E. NeMoyer
      • Paramus, New Jersey, United States, 07652
      • Ridgewood, New Jersey, United States, 07450
        • Suspended
        • Neurosurgeons of New Jersey-Ridgewood
      • Ridgewood, New Jersey, United States, 07450
      • Voorhees Township, New Jersey, United States, 08043
        • Recruiting
        • MD Anderson Cancer Center at Cooper-Voorhees
        • Contact:
          • Site Public Contact
          • Phone Number: 856-325-6757
        • Principal Investigator:
          • Veli Bakalov
      • Westwood, New Jersey, United States, 07675
        • Suspended
        • Valley Health System-Hematology/Oncology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Moises Harari-Turquie
      • Las Cruces, New Mexico, United States, 88011
        • Recruiting
        • Memorial Medical Center-Las Cruces
        • Principal Investigator:
          • Moises Harari-Turquie
        • Contact:
    • New York
      • Glens Falls, New York, United States, 12801
        • Recruiting
        • Glens Falls Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 518-926-6700
        • Principal Investigator:
          • Aqeel A. Gillani
      • Oswego, New York, United States, 13126
        • Active, not recruiting
        • Upstate Cancer Center at Oswego
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Paul M. Barr
      • Syracuse, New York, United States, 13210
        • Active, not recruiting
        • State University of New York Upstate Medical University
      • Syracuse, New York, United States, 13215
        • Active, not recruiting
        • SUNY Upstate Medical Center-Community Campus
      • The Bronx, New York, United States, 10468
        • Recruiting
        • James J Peters VA Medical Center
        • Contact:
        • Principal Investigator:
          • Susan E. Bates
      • Verona, New York, United States, 13478
        • Active, not recruiting
        • Upstate Cancer Center at Verona
      • Webster, New York, United States, 14580
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Sanford South University Medical Center
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 701-234-6161
      • Fargo, North Dakota, United States, 58122
      • Fargo, North Dakota, United States, 58103
        • Recruiting
        • Southpointe-Sanford Medical Center Fargo
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 605-312-3320
      • Fargo, North Dakota, United States, 58104
        • Recruiting
        • Sanford Medical Center Fargo
        • Principal Investigator:
          • Daniel Almquist
        • Contact:
          • Site Public Contact
          • Phone Number: 800-437-4010
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Active, not recruiting
        • Indu and Raj Soin Medical Center
      • Boardman, Ohio, United States, 44512
        • Active, not recruiting
        • Saint Elizabeth Boardman Hospital
      • Centerville, Ohio, United States, 45459
        • Active, not recruiting
        • Dayton Physicians LLC-Miami Valley South
      • Cincinnati, Ohio, United States, 45220
      • Cincinnati, Ohio, United States, 45242
      • Cincinnati, Ohio, United States, 45247
      • Cincinnati, Ohio, United States, 45255
      • Cincinnati, Ohio, United States, 45236
        • Active, not recruiting
        • Oncology Hematology Care Inc-Kenwood
      • Dayton, Ohio, United States, 45415
        • Active, not recruiting
        • Dayton Physician LLC - Englewood
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Armes Family Cancer Center
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Blanchard Valley Hospital
      • Findlay, Ohio, United States, 45840
        • Active, not recruiting
        • Orion Cancer Care
      • Franklin, Ohio, United States, 45005
        • Active, not recruiting
        • Dayton Physicians LLC-Atrium
      • Greenville, Ohio, United States, 45331
        • Active, not recruiting
        • Dayton Physicians LLC-Wayne
      • Greenville, Ohio, United States, 45331
        • Active, not recruiting
        • Wayne Hospital
      • Kettering, Ohio, United States, 45409
        • Active, not recruiting
        • Greater Dayton Cancer Center
      • Kettering, Ohio, United States, 45429
        • Active, not recruiting
        • Kettering Medical Center
      • Troy, Ohio, United States, 45373
        • Active, not recruiting
        • Dayton Physicians LLC - Troy
      • Warren, Ohio, United States, 44484
        • Active, not recruiting
        • Saint Joseph Warren Hospital
      • Youngstown, Ohio, United States, 44501
        • Active, not recruiting
        • Saint Elizabeth Youngstown Hospital
    • Oklahoma
      • Lawton, Oklahoma, United States, 73505
        • Recruiting
        • Cancer Centers of Southwest Oklahoma Research
        • Contact:
          • Site Public Contact
          • Phone Number: 877-231-4440
        • Principal Investigator:
          • Raid Aljumaily
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Raid Aljumaily
      • 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
      • Baker City, Oregon, United States, 97814
        • Suspended
        • Saint Alphonsus Cancer Care Center-Baker City
      • Gresham, Oregon, United States, 97030
        • Recruiting
        • Legacy Mount Hood Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Mei Dong
      • Ontario, Oregon, United States, 97914
        • Suspended
        • Saint Alphonsus Cancer Care Center-Ontario
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Legacy Good Samaritan Hospital and Medical Center
        • Principal Investigator:
          • Mei Dong
        • Contact:
          • Site Public Contact
          • Phone Number: 800-220-4937
          • Email: cancer@lhs.org
      • Salem, Oregon, United States, 97301
        • Recruiting
        • Salem Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-561-2618
        • Principal Investigator:
          • John Strother
      • Tualatin, Oregon, United States, 97062
        • Recruiting
        • Legacy Meridian Park Hospital
        • Principal Investigator:
          • Mei Dong
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-1742
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Recruiting
        • Christiana Care Health System-Concord Health Center
        • Principal Investigator:
          • Gregory A. Masters
        • Contact:
      • Danville, Pennsylvania, United States, 17822
        • Recruiting
        • Geisinger Medical Center
        • Contact:
        • Principal Investigator:
          • James M. Dolezal
      • Dickson City, Pennsylvania, United States, 18519
        • Recruiting
        • Geisinger Cancer Center Dickson City
        • Contact:
        • Principal Investigator:
          • James M. Dolezal
      • Hazleton, Pennsylvania, United States, 18201
        • Recruiting
        • Geisinger Medical Center-Cancer Center Hazleton
        • Contact:
        • Principal Investigator:
          • James M. Dolezal
      • Lewisburg, Pennsylvania, United States, 17837
        • Recruiting
        • Geisinger Medical Oncology-Lewisburg
        • Contact:
        • Principal Investigator:
          • James M. Dolezal
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Recruiting
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contact:
        • Principal Investigator:
          • James M. Dolezal
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Barry Gibney
      • Florence, South Carolina, United States, 29506
        • Recruiting
        • McLeod Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Rajesh Bajaj
      • Gaffney, South Carolina, United States, 29341
        • Recruiting
        • Gibbs Cancer Center-Gaffney
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Greenville, South Carolina, United States, 29601
        • Recruiting
        • Saint Francis Hospital
        • Principal Investigator:
          • Stephen H. Dyar
        • Contact:
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Saint Francis Cancer Center
        • Principal Investigator:
          • Stephen H. Dyar
        • Contact:
      • Greenwood, South Carolina, United States, 29646
        • Recruiting
        • Self Regional Healthcare
        • Contact:
        • Principal Investigator:
          • Barry Gibney
      • Greer, South Carolina, United States, 29651
        • Recruiting
        • Gibbs Cancer Center-Pelham
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Spartanburg Medical Center
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • North Grove Medical Park
        • Principal Investigator:
          • Michael Humeniuk
        • Contact:
          • Site Public Contact
          • Phone Number: 864-560-6812
      • Spartanburg, South Carolina, United States, 29307
        • Recruiting
        • Spartanburg Medical Center - Mary Black Campus
        • Principal Investigator:
          • Michael Humeniuk
        • Contact:
          • Site Public Contact
          • Phone Number: 864-560-6812
      • Union, South Carolina, United States, 29379
        • Recruiting
        • SMC Center for Hematology Oncology Union
        • Contact:
        • Principal Investigator:
          • Michael Humeniuk
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
      • Sioux Falls, South Dakota, United States, 57117-5134
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Collierville
        • Contact:
        • Principal Investigator:
          • Raymond U. Osarogiagbon
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Contact:
        • Principal Investigator:
          • Raymond U. Osarogiagbon
    • Texas
      • Dallas, Texas, United States, 75390
        • Suspended
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Houston, Texas, United States, 77026-1967
        • Suspended
        • Lyndon Baines Johnson General Hospital
    • Vermont
      • Saint Johnsbury, Vermont, United States, 05819
        • Recruiting
        • Dartmouth Cancer Center - North
        • Contact:
        • Principal Investigator:
          • Dana M. Ferrari-Light
    • Virginia
      • Charlottesville, Virginia, United States, 22908
    • Washington
      • Silverdale, Washington, United States, 98383
        • Recruiting
        • Saint Joseph Medical Center Hematology and Oncology - Silverdale
        • Principal Investigator:
          • Shahzad Siddique
        • Contact:
      • Vancouver, Washington, United States, 98686
        • Recruiting
        • Legacy Salmon Creek Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 503-413-2150
        • Principal Investigator:
          • Mei Dong
      • Vancouver, Washington, United States, 98684
        • Recruiting
        • Legacy Cancer Institute Medical Oncology and Day Treatment
        • Principal Investigator:
          • Mei Dong
        • Contact:
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Suspended
        • Langlade Hospital and Cancer Center
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • ThedaCare Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • Berlin, Wisconsin, United States, 54923
        • Recruiting
        • ThedaCare Cancer Care - Berlin
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • Chippewa Falls, Wisconsin, United States, 54729
      • Eau Claire, Wisconsin, United States, 54701
      • Green Bay, Wisconsin, United States, 54301
        • Recruiting
        • Saint Vincent Hospital Cancer Center Green Bay
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Green Bay, Wisconsin, United States, 54303
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • Michael O. Ojelabi
      • Ladysmith, Wisconsin, United States, 54848
      • Marshfield, Wisconsin, United States, 54449
      • Medford, Wisconsin, United States, 54451
        • Suspended
        • Aspirus Medford Hospital
      • Menomonee Falls, Wisconsin, United States, 53051
        • Recruiting
        • Froedtert Menomonee Falls Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 262-257-5100
        • Principal Investigator:
          • Paul L. Linsky
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-3666
        • Principal Investigator:
          • Paul L. Linsky
      • Milwaukee, Wisconsin, United States, 53295
        • Recruiting
        • Zablocki Veterans Administration Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-469-6614
        • Principal Investigator:
          • Janet Retseck
      • Minocqua, Wisconsin, United States, 54548
      • Mukwonago, Wisconsin, United States, 53149
        • Recruiting
        • ProHealth D N Greenwald Center
        • Contact:
        • Principal Investigator:
          • Timothy R. Wassenaar
      • Neenah, Wisconsin, United States, 54956
        • Recruiting
        • ThedaCare Regional Medical Center - Neenah
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • Neillsville, Wisconsin, United States, 54456
      • New London, Wisconsin, United States, 54961
        • Recruiting
        • ThedaCare Cancer Care - New London
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • Daniel M. Anderson
      • Oak Creek, Wisconsin, United States, 53154
        • Recruiting
        • Drexel Town Square Health Center
        • Contact:
          • Site Public Contact
          • Phone Number: 414-805-0505
        • Principal Investigator:
          • Paul L. Linsky
      • Oconomowoc, Wisconsin, United States, 53066
        • Recruiting
        • ProHealth Oconomowoc Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7878
      • Oconto Falls, Wisconsin, United States, 54154
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Oshkosh, Wisconsin, United States, 54904
        • Recruiting
        • ThedaCare Cancer Care - Oshkosh
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • Rhinelander, Wisconsin, United States, 54501
        • Suspended
        • Aspirus Cancer Care - James Beck Cancer Center
      • Rice Lake, Wisconsin, United States, 54868
      • Shawano, Wisconsin, United States, 54166
        • Recruiting
        • ThedaCare Cancer Care - Shawano
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Sheboygan, Wisconsin, United States, 53081
        • Recruiting
        • Sheboygan Physicians Group
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Stevens Point, Wisconsin, United States, 54482
      • Stevens Point, Wisconsin, United States, 54481
        • Suspended
        • Aspirus Cancer Care - Stevens Point
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Recruiting
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Principal Investigator:
          • Anthony J. Jaslowski
        • Contact:
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • ProHealth Waukesha Memorial Hospital
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
          • Site Public Contact
          • Phone Number: 262-928-7632
      • Waukesha, Wisconsin, United States, 53188
        • Recruiting
        • UW Cancer Center at ProHealth Care
        • Principal Investigator:
          • Timothy R. Wassenaar
        • Contact:
      • Waupaca, Wisconsin, United States, 54981
        • Recruiting
        • ThedaCare Cancer Care - Waupaca
        • Contact:
        • Principal Investigator:
          • Matthias Weiss
      • Wausau, Wisconsin, United States, 54401
      • Wausau, Wisconsin, United States, 54401
        • Suspended
        • Aspirus Regional Cancer Center
      • 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:
          • Paul L. Linsky
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Suspended
        • Aspirus Cancer Care - Wisconsin Rapids
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Recruiting
        • Memorial Hospital of Laramie County
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Cody, Wyoming, United States, 82414
        • Recruiting
        • Billings Clinic-Cody
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed surgically resectable stage IIA to IIIB NSCLC according to the American Joint Committee on Cancer (AJCC) 9th edition (stage IIA to IIIB NSCLC up to single station N2, according to the AJCC 8th edition)

    * Note: Patients with resectable stage N2a or T4 are eligible, but patients with stage N2b or N3 are not eligible. Patients with known EGFR or ALK alterations are excluded

  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (or Karnofsky ≥ 60%)
  • No prior systemic treatment for NSCLC within 5 years except stage 1 and 2 cancers treated with curative intent
  • No treatment for another malignancy within 3 years prior to registration, except for stage 1 or 2 cancers treated for curative intent; patients must be disease free for one year prior to registration. Patients with non-melanoma skin cancer, urothelial carcinoma in situ (Tis), noninvasive papillary carcinoma of the urinary bladder (Ta), prostatic intraepithelial neoplasia (PIN), ductal carcinoma in situ (DCIS) of the breast, or cervical intraepithelial neoplasia (CIN) of the uterine cervix are also eligible
  • No active autoimmune disease, interstitial lung disease, or transplant that precludes safe treatment with immune checkpoint inhibitors
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

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
Experimental: Arm 1 (surgery, adjuvant therapy)

SURGERY: Patients undergo surgery within 28 days of registration.

ADJUVANT THERAPY: Patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles and immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines.

Patients also undergo CT throughout the study and may undergo MRI and/or PET/CT at screening.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • PET Scan
Procedure: Computed Tomography
Undergo CT and/or PET/CT
Other Names:
  • CAT Scan
  • CT Scan
Procedure: Surgical Procedure
undergo surgery
Drug: Cisplatin
Give cisplatin
Drug: Carboplatin
Give Carboplatin
Drug: Pemetrexed
Give Pemetrexed
Drug: Gemcitabine
Give Gemcitabine
Drug: Docetaxel
Give Docetaxel
Drug: Vinorelbine
Give Vinorelbine
Drug: Nivolumab
Give Nivolumab
Drug: Pembrolizumab
Give Pembrolizumab
Drug: Atezolizumab
Give Atezolizumab
Experimental: Arm 2 (neoadjuvant therapy, surgery, adjuvant therapy)

NEOADJUVANT THERAPY: Within 28 days of registration, patients receive platinum-based doublet chemotherapy (cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and/or vinorelbine) for up to 4 cycles in combination with immune checkpoint inhibitor (nivolumab, pembrolizumab, and/or atezolizumab) according to current approved guidelines.

SURGERY: Patients undergo surgery.

ADJUVANT THERAPY: Patients receive immune checkpoint inhibitor therapy (nivolumab, pembrolizumab, and/or atezolizumab) for up to 1 year in the absence of disease progression or unacceptable toxicity according to current approved guidelines.

Patients also undergo CT throughout the study and may undergo MRI and/or PET/CT at screening.
Procedure: Magnetic Resonance Imaging
Undergo MRI
Other Names:
  • MRI
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • PET Scan
Procedure: Computed Tomography
Undergo CT and/or PET/CT
Other Names:
  • CAT Scan
  • CT Scan
Procedure: Surgical Procedure
undergo surgery
Drug: Cisplatin
Give cisplatin
Drug: Carboplatin
Give Carboplatin
Drug: Pemetrexed
Give Pemetrexed
Drug: Gemcitabine
Give Gemcitabine
Drug: Docetaxel
Give Docetaxel
Drug: Vinorelbine
Give Vinorelbine
Drug: Nivolumab
Give Nivolumab
Drug: Pembrolizumab
Give Pembrolizumab
Drug: Atezolizumab
Give Atezolizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year real-world event-free survival (rwEFS)
Time Frame: From the date of randomization to the date of the first of the following events: failure to undergo resection for any reason, recurrence or progression at any time after surgery, or death from any cause, assessed at 3 years
Time to event analyses will be summarized using the Kaplan-Meier method, where both the stratified and unstratified log-rank test will be used to compare the distributions across the treatment arms. For the primary analysis of 3-year rwEFS rate, we will compare the rwEFS curves at 3 years, using the difference in Kaplan-Meier estimates for the survival functions. The test statistic will be derived from the difference in the estimated Kaplan-Meier values between two arms at 3 years, using the Greenwood estimate of the variances. rwEFS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals. The comparison of the rwEFS post 3-years between the two arms among patients who do not experience an event by 3 years, will involve assessing the probability of a longer rwEFS on the perioperative arm. Non-parametric estimation and inference methods will be used for analysis.
From the date of randomization to the date of the first of the following events: failure to undergo resection for any reason, recurrence or progression at any time after surgery, or death from any cause, assessed at 3 years
Overall survival (OS)
Time Frame: From randomization until death from any cause, assessed up to 10 years
Time to event analyses will be summarized using the Kaplan-Meier method, where both the stratified and unstratified log-rank test will be used to compare the distributions across the treatment arms. OS rates at 1 year, 2 years, and 5 years will also be reported, along with 95% confidence intervals.
From randomization until death from any cause, assessed up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of surgical resection
Time Frame: Up to 10 years.
Rates of resection will be tabulated and compared between the arms using chi-square tests or Fisher's exact tests. Univariable Cox models stratified by the stratification factors used in the randomization will be used to understand the impact of baseline covariates, resection status and systemic treatments on outcomes.
Up to 10 years.
Rates of complete resection (R0)
Time Frame: Up to 10 years.
Rates of R0 resection will be tabulated and compared between the arms using chi-square tests or Fisher's exact tests. Univariable Cox models stratified by the stratification factors used in the randomization will be used to understand the impact of baseline covariates, resection status and systemic treatments on outcomes.
Up to 10 years.
Incidence of adverse events (AEs)
Time Frame: Up to 10 years.
Adverse events will be recorded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for each patient. Frequency tables and summary statistics will be used to determine the overall patterns within and across the arms.
Up to 10 years.
Pathological complete response (pCR)
Time Frame: Up to 10 years
Pathologic complete response is defined as having no viable invasive cancer in the lung and lymph nodes (ypT0 ypN0 or ypT0/is ypN0) based on guidelines published by National Comprehensive Cancer Network and International Association for the Study of Lung Cancer. Cox regression models will be used to evaluate the association between pCR and rwEFS in perioperative arm (arm 2). The hazard ratio and corresponding 95% confidence interval will be reported. Multivariable landmark and time dependent models will be subsequently explored.
Up to 10 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimates of treatment effect by sex
Time Frame: Up to 10 years.
Estimates of 3-year rwEFS rates and hazard ratio for OS and the corresponding 95% confidence intervals (CIs) will be evaluated by sex.
Up to 10 years.
Estimates of treatment effect by race
Time Frame: Up to 10 years
Estimates of 3-year rwEFS rates and hazard ratio for OS and the corresponding 95% confidence intervals (CIs) will be evaluated by race.
Up to 10 years
Estimates of treatment effect by ethnicity
Time Frame: Up to 10 years
Estimates of 3-year rwEFS rates and hazard ratio for OS and the corresponding 95% confidence intervals (CIs) will be evaluated by ethnicity.
Up to 10 years

Collaborators and Investigators

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

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Daniel Morgensztern, MD, Alliance for Clinical Trials in Oncology
  • Study Chair: Raid Aljumaily, MD, Alliance for Clinical Trials in Oncology
  • Study Chair: Linda Martin, MD, Alliance for Clinical Trials in Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 11, 2024

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2030

Study Registration Dates

First Submitted

October 7, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Actual)

October 9, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTIU2317-A082304-S2402
  • NCI-2024-06356 (Other Identifier: NCI Clinical Trials Reporting Program)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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