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Phase 3Recruiting

Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer

Sponsored by Canadian Cancer Trials Group

About this study

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.

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.

Where this study is enrolling (71)

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona

    Call +1 480-342-2000

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  • City of Hope Comprehensive Cancer Center

    Duarte, California

    I'm interested

  • City of Hope at Irvine Lennar

    Irvine, California

    Call 877-467-3411

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  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado

    I'm interested

  • CTCA at Southeastern Regional Medical Center

    Newnan, Georgia

    Call 770-400-6629

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Show all 71 locations

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho

    I'm interested

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho

    I'm interested

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho

    I'm interested

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho

    I'm interested

  • Alton Memorial Hospital

    Alton, Illinois

    Call 618-463-7323

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  • Crossroads Cancer Center

    Effingham, Illinois

    I'm interested

  • Decatur Memorial Hospital

    Decatur, Illinois

    I'm interested

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois

    I'm interested

  • Memorial Hospital East

    Shiloh, Illinois

    I'm interested

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois

    I'm interested

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois

    I'm interested

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois

    I'm interested

  • Northwestern Medicine Glenview Outpatient Center

    Glenview, Illinois

    Call 312-695-1102

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  • Northwestern Medicine Grayslake Outpatient Center

    Grayslake, Illinois

    Call 312-695-1102

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  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois

    I'm interested

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois

    I'm interested

  • Northwestern Medicine Orland Park

    Orland Park, Illinois

    I'm interested

  • Northwestern University

    Chicago, Illinois

    I'm interested

  • UI Healthcare Mission Cancer and Blood - Pella

    Pella, Iowa

    I'm interested

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa

    Call 515-241-3305

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

    Clive, Iowa

    Call 515-241-3305

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  • Iowa Methodist Medical Center

    Des Moines, Iowa

    Call 515-241-6727

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

    Des Moines, Iowa

    Call 515-241-3305

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  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa

    Call 515-241-3305

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  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa

    Call 319-363-2690

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  • Mercy Medical Center - Des Moines

    Des Moines, Iowa

    Call 515-241-3305

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  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa

    Call 515-241-3305

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  • Mercy Hospital

    Cedar Rapids, Iowa

    Call 319-365-4673

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  • Mayo Clinic in Rochester

    Rochester, Minnesota

    Call 855-776-0015

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  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota

    I'm interested

  • Miller-Dwan Hospital

    Duluth, Minnesota

    I'm interested

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri

    I'm interested

  • Washington University School of Medicine

    St Louis, Missouri

    I'm interested

  • Saint Francis Medical Center

    Cape Girardeau, Missouri

    I'm interested

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri

    I'm interested

  • Siteman Cancer Center-South County

    St Louis, Missouri

    I'm interested

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri

    I'm interested

  • Nebraska Medicine-Village Pointe

    Omaha, Nebraska

    Call 402-559-5600

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  • University of Nebraska Medical Center

    Omaha, Nebraska

    I'm interested

  • Nebraska Medicine-Bellevue

    Bellevue, Nebraska

    I'm interested

  • Stony Brook University Medical Center

    Stony Brook, New York

    Call 800-862-2215

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  • Mount Sinai West

    New York, New York

    I'm interested

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York

    Call 516-734-8896

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  • University of Rochester

    Rochester, New York

    Call 585-275-5830

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  • Queens Cancer Center

    Rego Park, New York

    Call 718-312-3446

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  • State University of New York Upstate Medical University

    Syracuse, New York

    Call 315-464-5476

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  • Mount Sinai Hospital

    New York, New York

    I'm interested

  • Manhattan Eye Ear and Throat Hospital

    New York, New York

    Call 212-434-4460

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  • Lenox Hill Hospital

    New York, New York

    Call 516-734-8896

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  • Montefiore Medical Center - Moses Campus

    The Bronx, New York

    I'm interested

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York

    I'm interested

  • Mount Sinai Chelsea

    New York, New York

    I'm interested

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio

    I'm interested

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma

    I'm interested

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania

    I'm interested

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania

    I'm interested

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania

    Call 412-621-2334

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  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania

    I'm interested

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania

    I'm interested

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania

    I'm interested

  • Geisinger Medical Center

    Danville, Pennsylvania

    I'm interested

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee

    Call 800-811-8480

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  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas

    I'm interested

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia

    I'm interested

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia

    I'm interested

  • Northwest Wisconsin Cancer Center

    Ashland, Wisconsin

    I'm interested
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.