Testing SBRT for non-small cell lung cancer

Inclusion

• +Participants of childbearing potential must have agreed to use a highly effective contraceptive method.
• +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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →).
• +Candidate for regulatory approved SOCStandard of careThe treatment normally given for a condition outside a study.Read more → first-line orsecond-line systemic therapy options.
• +Participants must be ≥ 18 years of age.
• +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.
• +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 ArmArmOne of the groups in a study, each receiving something different.Read more → 1, SBRT must be initiated within 3 weeks of participant enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• +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.
• +Participants must be accessible for treatment and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →, and follow-up.
• +ECOG performance status of 0, 1 or 2.
• +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 controlControl groupThe group a new treatment is measured against.Read more →, MRLinac, fiducial insertion, etc.) and accounting for previous radiotherapy overlap. Safety must be assessed and determined by a radiation oncologist.
• +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.
• +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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
• +Reimbursement of continued SOC ICI and chemotherapy systemic therapies may not be uniform across all sites. In the event that siteTrial siteA hospital or clinic where a study is actually run.Read more →/investigator is unable to provide access to the drug, participant will not be eligible for this trial.