Radiation plus immunotherapy: a new hope for hard-to-treat lung cancer?

NCT ID NCT04929041

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 11 times

Summary

This study is for people with advanced non-small cell lung cancer that does not have the PD-L1 marker, making it harder to treat with immunotherapy alone. The trial compares standard immunotherapy (with or without chemotherapy) to the same treatment plus radiation therapy. The goal is to see if adding radiation can stop the cancer from growing and help patients live longer. The study is currently on hold.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: nivolumab and ipilimumab (immunotherapy drugs)
What this could lead to: If successful, this could show that adding radiation to immunotherapy helps people with PD-L1-negative lung cancer live longer and keep their cancer under control.
What could go wrong: This trial is currently suspended, and it is a phase II/III study, so results are not yet known. The combination may not improve outcomes and could increase side effects from both treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 427 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologic or cytologic diagnosis of stage IV NSCLC using version American Joint Committee on Cancer (AJCC) 8th edition (includes M1a, M1b, and M1c stage disease). Patients with stage IIIB and IIIC disease are eligible if they are not a candidate for combined chemotherapy and radiation * PD-L1 expression tumor proportion score (TPS) \< 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed patients are not eligible. The assay must have been performed locally by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory. The type of assay will be recorded * For non-squamous patients only (adenocarcinoma or adenosquamous): EGFR, ALK and ROS1 testing must be done locally. No patients with known actionable EGFR mutations (except exon 20 insertion), ALK or ROS1 mutations that can be treated with oral tyrosine inhibitors * Measurable disease based on RECIST 1.1, including at least two cancerous deposits. At least one deposit must be RECIST measurable (and not to be irradiated) while at least one OTHER deposit (measurable or non-measurable) must meet criteria for three 8 gray (Gy) doses of radiation * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * No more than three weeks of treatment with systemic chemotherapy or immunotherapy for advanced NSCLC * No more than three weeks of treatment with checkpoint inhibitors for metastatic lung cancer * No treatment with chemotherapy or immunotherapy for non-metastatic disease (e.g., adjuvant therapy) within 6 months prior to registration * No systemic immunostimulatory or immunosuppressive drugs, including \> 10 mg prednisone equivalent per day, within 2 weeks or 5 half-live of the drug, whichever is shorter. Steroid premedication per local standard is allowed * \>= 1 week prior to registration since palliative (including central nervous system \[CNS\]) radiotherapy to any tumor site * No prior allogeneic tissue/solid organ transplant * No uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements * No current pneumonitis or history of non-infectious pneumonitis that required steroids * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration * No active auto-immune disease that requires systemic therapy within 2 years prior to registration. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed * No known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid \[RNA\] \[qualitative\] is detected) infection * No patients with symptomatic central nervous system metastases and/or carcinomatous meningitis. Patients with small asymptomatic brain metastases are eligible as are patients with treated brain metastases that require no steroids * Not pregnant and not nursing, because this study involves radiation as well as potentially chemotherapy which have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =\< 7 days prior to registration is required * No patients with a "currently active" second malignancy that is progressing or has required active treatment within the last 2 years. Participants with non-melanoma skin cancers or carcinoma in-situ (e.g., breast carcinoma, urothelial carcinoma or cervical cancer in situ) or localized prostate cancer (T1-3, N0, M0) that have undergone potentially curative therapy are eligible * No hypersensitivity (\>= grade 3) to immunotherapy and/or any of its excipients * No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g.,FluMist \[registered trademark\]) are live attenuated vaccines and are not allowed. COVID-19 vaccine is allowed * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Calculated (Calc.) creatinine clearance \>= 45 mL/min * Total bilirubin =\< 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN)

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma of Lung adenosquamous lung carcinoma lung adenocarcinoma lung cancer lung carcinoma lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lung adenocarcinoma Lung adenosquamous carcinoma Lung non-small cell carcinoma Stage IIIB lung cancer ajcc V8 Stage IIIC lung cancer ajcc V8 Stage IV lung cancer ajcc V8

Contacts and locations

Locations

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704, United States
Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States
Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States
Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715, United States
Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States
CTCA at Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States
Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528, United States
Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017, United States
Cancer Centers of Southwest Oklahoma Research

Lawton, Oklahoma, 73505, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle at The Riverfront

Danville, Illinois, 61832, United States
Chelsea Hospital

Chelsea, Michigan, 48118, United States
Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317, United States
City of Hope Antelope Valley

Lancaster, California, 93534, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
City of Hope South Pasadena

South Pasadena, California, 91030, United States
City of Hope Upland

Upland, California, 91786, United States
City of Hope at Irvine Lennar

Irvine, California, 92618, United States
Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303, United States
CommonSpirit Saint Joseph Medical Center - East Lexington

Lexington, Kentucky, 40509, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Duke Cancer Center Raleigh

Raleigh, North Carolina, 27609, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Fremont - Rideout Cancer Center

Marysville, California, 95901, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837, United States
Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, 96161, United States
Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States
Greater Regional Medical Center

Creston, Iowa, 50801, United States
Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States
HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269, United States
Helen F Graham Cancer Center

Newark, Delaware, 19713, United States
Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States
Hurley Medical Center

Flint, Michigan, 48503, United States
Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Legacy Cancer Institute Medical Oncology and Day Treatment

Vancouver, Washington, 98684, United States
Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210, United States
Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States
Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States
Legacy Salmon Creek Hospital

Vancouver, Washington, 98686, United States
Lenox Hill Hospital

New York, New York, 10075, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States
MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073, United States
MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, 04106, United States
MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, 04074, United States
Manhattan Eye Ear and Throat Hospital

New York, New York, 10065, United States
Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States
Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States
Mary Greeley Medical Center

Ames, Iowa, 50010, United States
Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States
Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States
McFarland Clinic - Ames

Ames, Iowa, 50010, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Medical Center of the Rockies

Loveland, Colorado, 80538, United States
Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Hospital North

Colorado Springs, Colorado, 80920, United States
Memorial Medical Center

Modesto, California, 95355, United States
Mercy Cancer Center-West Lakes

Clive, Iowa, 50325, United States
Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Mercy Hospital South

St Louis, Missouri, 63128, United States
Mercy Hospital Springfield

Springfield, Missouri, 65804, United States
Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314, United States
Mercy Medical Center-West Lakes

West Des Moines, Iowa, 50266, United States
Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341, United States
Miller-Dwan Hospital

Duluth, Minnesota, 55805, United States
Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States
Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080, United States
Morton Plant Hospital

Clearwater, Florida, 33756, United States
Mount Sinai Chelsea

New York, New York, 10011, United States
Mount Sinai Hospital

New York, New York, 10029, United States
Mount Sinai West

New York, New York, 10019, United States
MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601, United States
MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764, United States
North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422, United States
Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042, United States
Northwest Wisconsin Cancer Center

Ashland, Wisconsin, 54806, United States
Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134, United States
Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115, United States
Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555, United States
Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026, United States
Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030, United States
Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States
Northwestern University

Chicago, Illinois, 60611, United States
Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
Parkland Health Center - Farmington

Farmington, Missouri, 63640, United States
Penn State Health Saint Joseph Medical Center

Reading, Pennsylvania, 19605, United States
Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States
Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401, United States
Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States
ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149, United States
ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States
Providence Queen of The Valley

Napa, California, 94558, United States
Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, 99362, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
SUNY Upstate Medical Center-Community Campus

Syracuse, New York, 13215, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, 33607, United States
Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301, United States
Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661, United States
Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
Springfield Clinic

Springfield, Illinois, 62702, United States
Springfield Memorial Hospital

Springfield, Illinois, 62781, United States
State University of New York Upstate Medical University

Syracuse, New York, 13210, United States
Summa Health System - Akron Campus

Akron, Ohio, 44304, United States
The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106, United States
The Iowa Clinic PC

West Des Moines, Iowa, 50266, United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114, United States
Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188, United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118, United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197, United States
Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Canton

Canton, Michigan, 48188, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106, United States
Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341, United States
Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154, United States
UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States
UCHealth Greeley Hospital

Greeley, Colorado, 80631, United States
UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States
UChicago Medicine Northwest Indiana

Crown Point, Indiana, 46307, United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314, United States
UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, 50325, United States
UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324, United States
UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188, United States
UW Health Carbone Cancer Center Rockford

Rockford, Illinois, 61114, United States
University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States
University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462, United States
University of Illinois

Chicago, Illinois, 60612, United States
University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
Upstate Cancer Center Radiation Oncology at Oswego

Oswego, New York, 13126, United States
Upstate Cancer Center at Hill Radiation Oncology

Syracuse, New York, 13210, United States
Upstate Cancer Center at Oswego

Oswego, New York, 13126, United States
Upstate Cancer Center at Verona

Verona, New York, 13478, United States
VCU Health Tappahannock Hospital

Tappahannock, Virginia, 22560, United States
VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235, United States
VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
West Virginia University Charleston Division

Charleston, West Virginia, 25304, United States
Winter Haven Hospital

Winter Haven, Florida, 33881, United States

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