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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

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

Qualifiers

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

Treatments tested in this trial

  • SBRT
  • First or second-line standard of care therapy

Treatment groups

320 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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