AzTrials
AzTrials

Lung AdenocarcinomaPhase 2/3NCT04929041

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

A Phase 2/3 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Lung Adenocarcinoma and Lung Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 169 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
427 participants
Where
169 sitesUnited States
Study dates
7 Oct 2022to 12 Dec 2030
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 27Show fewer
  • 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)

Who cannot join

None listed.

Trial locations and contacts

169 sites in 1 country.

169 sites in 1 country

United States169 sites

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin, 54806

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

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

    Clive, Iowa, 50325

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • UChicago Medicine Northwest Indiana

    Crown Point, Indiana, 46307

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

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

    Des Moines, Iowa, 50309

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois, 60026

  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois, 60030

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • City of Hope Antelope Valley

    Lancaster, California, 93534

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • CommonSpirit Saint Joseph Medical Center - East Lexington

    Lexington, Kentucky, 40509

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Memorial Medical Center

    Modesto, California, 95355

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

  • Providence Queen of The Valley

    Napa, California, 94558

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • Mount Sinai Chelsea

    New York, New York, 10011

  • Mount Sinai West

    New York, New York, 10019

  • Mount Sinai Hospital

    New York, New York, 10029

  • Manhattan Eye Ear and Throat Hospital

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • CTCA at Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

  • Upstate Cancer Center at Oswego

    Oswego, New York, 13126

  • Upstate Cancer Center Radiation Oncology at Oswego

    Oswego, New York, 13126

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Duke Cancer Center Raleigh

    Raleigh, North Carolina, 27609

  • Penn State Health Saint Joseph Medical Center

    Reading, Pennsylvania, 19605

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • UW Health Carbone Cancer Center Rockford

    Rockford, Illinois, 61114

  • Phelps Health Delbert Day Cancer Institute

    Rolla, Missouri, 65401

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • MaineHealth Cancer Care Center of York County

    Sanford, Maine, 04073

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

    Savannah, Georgia, 31405

  • MaineHealth Maine Medical Center- Scarborough

    Scarborough, Maine, 04074

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • MaineHealth Cancer Care and IV Therapy - South Portland

    South Portland, Maine, 04106

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Upstate Cancer Center at Hill Radiation Oncology

    Syracuse, New York, 13210

  • SUNY Upstate Medical Center-Community Campus

    Syracuse, New York, 13215

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

    Tampa, Florida, 33607

  • VCU Health Tappahannock Hospital

    Tappahannock, Virginia, 22560

  • MyMichigan Medical Center Tawas

    Tawas City, Michigan, 48764

  • Gene Upshaw Memorial Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Saint Luke's Cancer Institute - Twin Falls

    Twin Falls, Idaho, 83301

  • City of Hope Upland

    Upland, California, 91786

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Legacy Cancer Institute Medical Oncology and Day Treatment

    Vancouver, Washington, 98684

  • Legacy Salmon Creek Hospital

    Vancouver, Washington, 98686

  • Upstate Cancer Center at Verona

    Verona, New York, 13478

  • Providence Saint Mary Regional Cancer Center

    Walla Walla, Washington, 99362

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

  • UW Cancer Center at ProHealth Care

    Waukesha, Wisconsin, 53188

  • Saint Mary's Oncology/Hematology Associates of West Branch

    West Branch, Michigan, 48661

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • The Iowa Clinic PC

    West Des Moines, Iowa, 50266

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania, 18711

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Winter Haven Hospital

    Winter Haven, Florida, 33881

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess if radiation improves the progression free survival (PFS, phase II portion) and overall survival (OS, phase III portion) of advanced stage non-small cell lung cancer (NSCLC) patients with PD-L1 tumor proportion score (TPS) < 1% who receive immunotherapy with or without chemotherapy.

SECONDARY OBJECTIVES:

  1. To estimate and compare the rates of >= grade 3-4 and all grade adverse events by Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 between the arms.

II. To summarize and compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) between the arms.

III. To determine and compare the objective response rate (ORR) per RECIST between the arms (including at both irradiated and un-irradiated sites).

QUALITY OF LIFE (QOL) OBJECTIVE:

  1. To assess the health-related QOL in both treatment arms.

CORRELATIVE SCIENCE OBJECTIVE:

  1. To evaluate changes in the peripheral immune microenvironment between the arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive nivolumab intravenously (IV) over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity or patients may receive standard of care systemic immunotherapy. Patients also undergo magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET) throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as echocardiography (ECHO) during screening.

Arm B: Patients receive nivolumab IV over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity or patients may receive standard of care systemic immunotherapy. Patients also undergo 3 fractions of radiation therapy every other day. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening.

After completion of study treatment, patients are followed up every 3 months for 3 years and then every 6 months for years 4-5 following randomization until disease progression. Following disease progression patients are followed for survival every 6 months for up to 5 years following randomization.

Being tested
Biopsy Procedure, Biospecimen Collection, Computed Tomography, Echocardiography Test, Ipilimumab
Medical subject headings
Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo tissue biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo ECHO

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS 734016, BMS-734016, BMS734016

    Given IV

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • NivolumabBiological

    Also called ABP 206, BCD-263, BMS 936558, BMS-936558

    Given IV

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation therapy

Study groups in NCT04929041
Study groupRoleWhat they receive
Arm A (immunotherapy, +/- chemotherapy)ExperimentalPatients receive nivolumab intravenously (IV) over 30 minutes on days 1 and 22 and ipilimumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 24 months in the absence of disease progression or unacceptable toxicity or patients may receive standard of care systemic immunotherapy. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Biological: Ipilimumab; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment
Arm B (immunotherapy, +/- chemotherapy, radiation therapy)ExperimentalPatients receive 1 of 6 treatment options as in Arm A. Patients also undergo 3 fractions of radiation therapy every other day. Patients also undergo MRI, CT, or PET throughout the trial. Patients may undergo blood sample collection and tissue biopsy on study as well as ECHO during screening.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Biological: Ipilimumab; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Procedure: Positron Emission Tomography; Other: Quality-of-Life Assessment; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) (Phase II)

    Will be performed on an intent-to-treat (ITT) basis.

    Measured: From randomization to disease progression or death of all causes, whichever comes first, assessed up to 5 years

  2. Overall survival (OS) (Phase III)

    Will be performed on an ITT basis. The comparison of the distributions of OS between treatment arms will be done with a one-sided stratified log-rank test). The rates at various time points (e.g., every 6 months after randomization) and medians of OS for each arm will be estimated using the Kaplan-Meier estimator. The associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Hazard ratios will be estimated using a stratified Cox regression model. The final phase III analysis of OS will be considered as "positive" if the stratified log-rank test statistics Z-value greater than the critical value adjusted for type 1 error using group sequential methods. Multivariable Cox models will be used to evaluate the treatment effect on survival time and its interaction with baseline covariates, including stage, systemic therapy, histology and performance status.

    Measured: From randomization and death of all causes, assessed up to 5 years

Secondary outcomes (4)

  1. PFS

    Assessed per Response Evaluation Criteria in Solid Tumors (RECIST).

    Measured: From randomization to disease progression or death of all causes, whichever comes first, assessed up to 5 years

  2. Objective response rate (ORR)

    Assessed per RECIST for both irradiated and un-irradiated areas. The ORRs between treatments will be compared with Fisher's exact test. The difference of ORR between treatments will be estimated by the Miettinen-Nurminen method and its 95% CI will be given. Multivariable logistic regression will be used to evaluate the treatment effect on ORR while adjusting for significant baseline covariates.

    Measured: Up to 5 years

  3. Quality of life

    Measured: Up to 5 years

  4. Incidence of treatment-related adverse events

    Treatment-related toxicity will be summarized by grade, type, and system organ class. Comparisons of the percentages of patients experiencing an adverse event between Arm A and Arm B will be performed using Fisher's exact test.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2021
  2. Study start7 Oct 2022
  3. Primary completion12 Dec 2030 (estimated)
  4. Study completion12 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
427 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04929041
Sponsor's protocol ID
NCI-2021-06042
Other IDs
NCI-2021-06042, A082002, A082002, U10CA180821
Status last verified
Aug 2026
First submitted
16 Jun 2021
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • Schild SE, Wang X, Bestvina CM, Williams T, Masters G, Singh AK, Stinchcombe TE, Salama JK, Wolf S, Zemla T, Duma N, Chun SG, Amini A, Kozono D, Watt C. Alliance A082002 -a randomized phase II/III trial of modern immunotherapy-based systemic therapy with or without SBRT for PD-L1-negative, advanced non-small cell lung cancer. Clin Lung Cancer. 2022 Jul;23(5):e317-e320. doi: 10.1016/j.cllc.2022.04.004. Epub 2022 Apr 30.

    PubMed 35613998

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Lung Adenocarcinoma and Lung Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 169 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 169 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (Phase II) (time frame: From randomization to disease progression or death of all causes, whichever comes first, assessed up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04929041, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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