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ACTIVE NOT RECRUITING

NCT04929041

PHASE2/PHASE3

Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.

Official title: A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without Radiation Therapy for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

427

Start Date

2022-10-07

Completion Date

2030-12-12

Last Updated

2026-10-01

Healthy Volunteers

Conditions

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

Interventions

PROCEDURE

Biopsy Procedure

Undergo tissue biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Echocardiography Test

Undergo ECHO

BIOLOGICAL

Ipilimumab

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

OTHER

Quality-of-Life Assessment

Ancillary studies

RADIATION

Radiation Therapy

Undergo radiation therapy

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)

Locations (169)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Memorial Medical Center

Modesto, California, United States

Providence Queen of The Valley

Napa, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

City of Hope Upland

Upland, California, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

Morton Plant Hospital

Clearwater, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Winter Haven Hospital

Winter Haven, Florida, United States

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

UChicago Medicine Northwest Indiana

Crown Point, Indiana, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Greater Regional Medical Center

Creston, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, United States

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

The Iowa Clinic PC

West Des Moines, Iowa, United States

CommonSpirit Saint Joseph Medical Center - East Lexington

Lexington, Kentucky, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

MaineHealth Cancer Care Center of York County

Sanford, Maine, United States

MaineHealth Maine Medical Center- Scarborough

Scarborough, Maine, United States

MaineHealth Cancer Care and IV Therapy - South Portland

South Portland, Maine, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Chelsea Hospital

Chelsea, Michigan, United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

MyMichigan Medical Center Saginaw

Saginaw, Michigan, United States

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

MyMichigan Medical Center Tawas

Tawas City, Michigan, United States

And 69 more locations on ClinicalTrials.gov

Clinical Research Directory

Testing the Addition of Radiation Therapy to the Usual Treatment (Immunotherapy With or Without Chemotherapy) for Advanced Stage Non-small Cell Lung Cancer Patients Who Are PD-L1 Negative

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (169)