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RecruitingInterventionalPhase 3

Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients With Metastatic Non-Small-Cell Lung Cancer

NCT ID: NCT06686771Sponsor: Canadian Cancer Trials GroupLast updated: 2026-06-09

Summary

This study is being done to answer the following question: Can the chance of lung cancer growing or spreading be lowered by adding targeted radiotherapy to the usual combination of drugs? This study is being done to find out if this approach is better or worse than the usual approach for lung cancer. The usual approach is defined as the care most people get for non-small cell lung cancer.

Detailed description

The usual approach for patients who are not in a study and whose disease has gotten worse is to switch treatments. Sometimes, combinations of drugs or radiotherapy are used. The study doctor can explain which treatment may be best. These treatments can reduce symptoms and may stop the tumour from growing for several months or longer.

Arms & interventions

  • RadiationSBRT

    Please refer to the current NCCN NSCLC guidelines for possible treatment options

  • OtherFirst or second-line standard of care therapy

    Please refer to the current NCCN NSCLC guidelines for possible treatment options.

Outcome measures

Primary

  • Progression-free survival

    Time frame: 5.5 years

  • Overall survival

    Time frame: 5.5 years

Secondary

  • Number and severity of adverse events

    Time frame: 5.5 years

  • Patient-reported adverse events utilizing PRO-CTCAE questionnaire

    Time frame: 5.5 years

  • Patient-reported quality of life utilizing EORTC-QLQ-C30 questionnaire

    Time frame: 5.5 years

  • Patient-reported quality of life utilizing QLQ-LC-13 questionnaire

    Time frame: 5.5 years

  • Cost-effectiveness utilizing EQ-5D-5L questionnaire (Canadian sites only)

    Time frame: 5.5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Metastatic disease (stage IV) detected on imaging and histologically and/or cytologically confirmed NSCLC as per the WHO Classification of Tumors and AJCC 8th Edition TNM Classification, without a driver mutation with an actionable first-line targeted therapy, for whom either ICI alone or combination ICI + chemotherapy is indicated * Oligoprogression on first-line ICI +/- chemotherapy systemic therapy after at least 3 cycles. * All sites of oligoprogression can be safely treated with SBRT or ablative radiotherapy as determined by radiation treatment preplan, including availability and tolerability of necessary technologies (e.g., active breathing control, MRLinac, fiducial insertion, etc.) and accounting for previous radiotherapy overlap. Safety must be assessed and determined by a radiation oncologist. * Patients with treated CNS disease who have radiologic and clinical evidence of stable brain metastases, with no evidence of cavitation or hemorrhage in the brain lesion, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization). * Candidate for regulatory approved SOC first-line orsecond-line systemic therapy options. * Participants must be ≥ 18 years of age. * ECOG performance status of 0, 1 or 2. * Participants that received prior adjuvant/neoadjuvant/consolidation systemic therapy (including chemotherapy and ICI ) are eligible if at least 6 months have elapsed between the completion of prior therapy and start of first-line treatment for metastatic disease. * Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic therapy. If participants experienced prior immune-mediated toxicity and have not yet re-initiated ICI therapy, please contact CCTG. Please also contact CCTG if participants have ongoing toxicity ≥ grade 1 felt to be clinically insignificant. * Previous surgery related to NSCLC in the curative or metastatic disease setting is permitted. Previous major surgery is permitted provided that surgery occurred at least 28 days prior to participant enrollment and that wound healing has occurred. * Prior external beam radiation related to NSCLC in the metastatic disease setting is permitted provided a minimum of 14 days (2 weeks) have elapsed between the last dose of radiation and date of enrollment. Patients that received prior external beam radiation therapy in the NSCLC curative disease setting (including the primary lesion) are eligible. Oligoprogressive lesions previously treated with external beam radiation are eligible as long they are clinically asymptomatic, and re-treatment is possible according to the investigator. * Prior conventional, non-stereotactic radiotherapy for palliative purposes is allowed, and if the palliated lesion subsequently progressed but asymptomatic not requiring immediate RT, the lesion can still be counted toward one of the five oligoprogressive lesions. * For Arm 1, SBRT must be initiated within 3 weeks of participant enrollment. * Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French, or Spanish. * Reimbursement of continued SOC ICI and chemotherapy systemic therapies may not be uniform across all sites. In the event that site/investigator is unable to provide access to the drug, participant will not be eligible for this trial. * Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up. * Participants of childbearing potential must have agreed to use a highly effective contraceptive method. Exclusion Criteria: * Large-cell neuroendocrine carcinoma (LCNEC), pulmonary carcinoid tumour or mixed small cell and non-small cell lung cancer are not eligible. * Presence of leptomeningeal disease. * Pregnancy. * Serious medical conditions in which radiotherapy of target lesions is contraindicated (e.g., scleroderma, Ataxia Telangiectasia (ATM), interstitial lung disease (ILD), Child-Pugh C liver function). * Any other condition in which in the judgement of the investigator would make the patient inappropriate for study entry. * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Concomitant medications should only exclude participants from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy; please consult the relevant product monographies. * Concurrent treatment with other anti-cancer therapy, including investigational agents. * Live attenuated vaccination administered within 30 days prior to enrollment/randomization.

Study locations (70)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054

Recruiting
Site Public Contact · Contact
Nathan Y. Yu · Principal Investigator

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Recruiting
Site Public Contact · Contact
Yufei Liu · Principal Investigator

City of Hope at Irvine Lennar

Irvine, California, 92618

Recruiting
Site Public Contact · Contact
Yufei Liu · Principal Investigator

Saint Mary's Hospital and Regional Medical Center

Grand Junction, Colorado, 81501

Recruiting
Site Public Contact · Contact
Lucas Gilbride · Principal Investigator

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

Recruiting
Site Public Contact · Contact
Charles W. Drescher · Principal Investigator

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

Recruiting
Site Public Contact · Contact
Charles W. Drescher · Principal Investigator

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

Recruiting
Site Public Contact · Contact
Charles W. Drescher · Principal Investigator

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

Recruiting
Site Public Contact · Contact
Charles W. Drescher · Principal Investigator

Alton Memorial Hospital

Alton, Illinois, 62002

Recruiting
Site Public Contact · Contact
Pamela Samson · Principal Investigator

Northwestern University

Chicago, Illinois, 60611

Recruiting
Site Public Contact · Contact
Laila A. Gharzai · Principal Investigator

Decatur Memorial Hospital

Decatur, Illinois, 62526

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

Recruiting
Site Public Contact · Contact
Laila A. Gharzai · Principal Investigator

Crossroads Cancer Center

Effingham, Illinois, 62401

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

Recruiting
Site Public Contact · Contact
Laila A. Gharzai · Principal Investigator

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, 60026

Recruiting
Site Public Contact · Contact
Laila A. Gharzai · Principal Investigator

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, 60030

Recruiting
Site Public Contact · Contact
Laila A. Gharzai · Principal Investigator

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

Recruiting
Site Public Contact · Contact
Laila A. Gharzai · Principal Investigator

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Northwestern Medicine Oak Brook

Oak Brook, Illinois, 60523

Recruiting
Site Public Contact · Contact
Laila A. Gharzai · Principal Investigator

Northwestern Medicine Orland Park

Orland Park, Illinois, 60462

Recruiting
Site Public Contact · Contact
Laila A. Gharzai · Principal Investigator

Memorial Hospital East

Shiloh, Illinois, 62269

Recruiting
Site Public Contact · Contact
Pamela Samson · Principal Investigator

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

Recruiting
Site Public Contact · Contact
Laila A. Gharzai · Principal Investigator

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, 50023

Recruiting
Site Public Contact · Contact
Seema Harichand-Herdt · Principal Investigator

Mercy Hospital

Cedar Rapids, Iowa, 52403

Recruiting
Site Public Contact · Contact
Deborah W. Wilbur · Principal Investigator

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403

Recruiting
Site Public Contact · Contact
Deborah W. Wilbur · Principal Investigator

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

Clive, Iowa, 50325

Recruiting
Site Public Contact · Contact
Seema Harichand-Herdt · Principal Investigator

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

Recruiting
Site Public Contact · Contact
Seema Harichand-Herdt · Principal Investigator

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, 50309

Recruiting
Site Public Contact · Contact
Seema Harichand-Herdt · Principal Investigator

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

Recruiting
Site Public Contact · Contact
Richard L. Deming · Principal Investigator

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, 50314

Recruiting
Site Public Contact · Contact
Seema Harichand-Herdt · Principal Investigator

UI Healthcare Mission Cancer and Blood - Pella

Pella, Iowa, 50219

Recruiting
Site Public Contact · Contact
Seema Harichand-Herdt · Principal Investigator

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa, 50263

Recruiting
Site Public Contact · Contact
Seema Harichand-Herdt · Principal Investigator

Miller-Dwan Hospital

Duluth, Minnesota, 55805

Recruiting
Site Public Contact · Contact
Bret E. Friday · Principal Investigator

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Recruiting
Site Public Contact · Contact
Nathan Y. Yu · Principal Investigator

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303

Recruiting
Site Public Contact · Contact
Donald J. Jurgens · Principal Investigator

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376

Recruiting
Site Public Contact · Contact
Pamela Samson · Principal Investigator

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

Recruiting
Site Public Contact · Contact
Pamela Samson · Principal Investigator

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting
Site Public Contact · Contact
Pamela Samson · Principal Investigator

Siteman Cancer Center-South County

St Louis, Missouri, 63129

Recruiting
Site Public Contact · Contact
Pamela Samson · Principal Investigator

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136

Recruiting
Site Public Contact · Contact
Pamela Samson · Principal Investigator

Nebraska Medicine-Bellevue

Bellevue, Nebraska, 68123

Recruiting
Site Public Contact · Contact
Weining Zhen · Principal Investigator

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118

Recruiting
Site Public Contact · Contact
Weining Zhen · Principal Investigator

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Recruiting
Site Public Contact · Contact
Weining Zhen · Principal Investigator

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042

Recruiting
Site Public Contact · Contact
A. G. Wernicke · Principal Investigator

Mount Sinai Chelsea

New York, New York, 10011

Recruiting
Site Public Contact · Contact
Robert M. Samstein · Principal Investigator

Mount Sinai West

New York, New York, 10019

Recruiting
Site Public Contact · Contact
Robert M. Samstein · Principal Investigator

Mount Sinai Hospital

New York, New York, 10029

Recruiting
Site Public Contact · Contact
Robert M. Samstein · Principal Investigator

Manhattan Eye Ear and Throat Hospital

New York, New York, 10065

Recruiting
Site Public Contact · Contact
A. G. Wernicke · Principal Investigator

Lenox Hill Hospital

New York, New York, 10075

Recruiting
Site Public Contact · Contact
A. G. Wernicke · Principal Investigator

Queens Cancer Center

Rego Park, New York, 11374

Recruiting
Site Public Contact · Contact
A. G. Wernicke · Principal Investigator

University of Rochester

Rochester, New York, 14642

Recruiting
Site Public Contact · Contact
Philip Sutera · Principal Investigator

Stony Brook University Medical Center

Stony Brook, New York, 11794

Recruiting
Site Public Contact · Contact
Kartik M. Mani · Principal Investigator

State University of New York Upstate Medical University

Syracuse, New York, 13210

Recruiting
Site Public Contact · Contact
Michael D. Mix · Principal Investigator

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461

Recruiting
Site Public Contact · Contact
Nitin Ohri · Principal Investigator

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467

Recruiting
Site Public Contact · Contact
Nitin Ohri · Principal Investigator

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting
Site Public Contact · Contact
Austin Sim · Principal Investigator

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Recruiting
Site Public Contact · Contact
Tyler Gunter · Principal Investigator

Geisinger Medical Center

Danville, Pennsylvania, 17822

Recruiting
Site Public Contact · Contact
Fiori Alite · Principal Investigator

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850

Recruiting
Site Public Contact · Contact
Joseph A. Miccio · Principal Investigator

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837

Recruiting
Site Public Contact · Contact
Fiori Alite · Principal Investigator

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

Recruiting
Site Public Contact · Contact
Neal McCall · Principal Investigator

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Recruiting
Site Public Contact · Contact
Cecilia Jiang · Principal Investigator

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

Recruiting
Site Public Contact · Contact
Neal McCall · Principal Investigator

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711

Recruiting
Site Public Contact · Contact
Fiori Alite · Principal Investigator

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, 37232

Recruiting
Site Public Contact · Contact
Evan C. Osmundson · Principal Investigator

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, 79106

Recruiting
Site Public Contact · Contact
Anita Ravipati · Principal Investigator

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

Recruiting
Site Public Contact · Contact
Renato G. Martins · Principal Investigator

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298

Recruiting
Site Public Contact · Contact
Renato G. Martins · Principal Investigator

Northwest Wisconsin Cancer Center

Ashland, Wisconsin, 54806

Recruiting
Site Public Contact · Contact
Bret E. Friday · Principal Investigator