About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
SBRT
RadiationPlease refer to the current NCCN NSCLC guidelines for possible treatment options
First or second-line standard of care therapy
Other interventionPlease refer to the current NCCN NSCLC guidelines for possible treatment options.
Treatment groups
Trial outcomes
Primary outcomes
Progression-free survival
Overall survival
Secondary outcomes
Number and severity of adverse events
Patient-reported adverse events utilizing PRO-CTCAE questionnaire
Patient-reported quality of life utilizing EORTC-QLQ-C30 questionnaire
Patient-reported quality of life utilizing QLQ-LC-13 questionnaire
Sponsors and contacts
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Canadian Cancer Trials Group
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborator
ECOG-ACRIN Cancer Research Group
Collaborator
NRG Oncology
Collaborator
SWOG Cancer Research Network
Collaborator