Radiotherapy for Metastatic Non-Small-Cell Lung Cancer

This study is investigating if adding SBRT (a type of radiation therapy) to your usual first or second-line standard of care therapy can help people with metastatic non-small cell lung cancer (lung cancer that has spread). The goal is to see if this combination is better or worse than the standard approach for lung cancer when the disease starts to grow again (oligoprogression). You may be able to join if you are 18 or older, have metastatic non-small cell lung cancer without a specific gene change (driver mutation) that would allow for a targeted therapy, and your cancer has shown some growth while on initial treatment. Researchers will measure how long people live without their cancer growing (progression-free survival) and how long they live overall (overall survival) over 5.5 years to determine if the new approach is successful. The study is currently unclear on its recruitment status and plans to enroll 320 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 320 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5.5 years to measure progression-free survival and overall survival.

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NCT06686771

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Canadian Cancer Trials Group
~320 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:SBRTFirst or second-line standard of care therapy

At a glance

Recruiting sites
75 of 75 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival
Measured over 5.5 years
+1 more outcome measured
Non-small Cell Lung Cancer
75 sites across 21 states
Illinois14
New York12
Iowa10
Pennsylvania7
Missouri6
Idaho4
Minnesota3
Nebraska3
  • C. Jillian Tsai · STUDY_CHAIR · University Health Network Princess Margaret Hospital, Toronto, ON Canada

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Eligibility criteria

Inclusion

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

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.
  • Progression-free survival5.5 years
  • Overall survival5.5 years