Pilot Study of Radiotherapy to the Lung Primary Before Standard Treatment in Advanced Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are investigating treatment options for patients diagnosed with advanced non-small cell lung cancer NSCLC who have a poor prognosis with current therapies. This pilot study aims to evaluate the safety and feasibility of adding stereotactic ablative radiotherapy SABR to the lung tumor before standard systemic therapy in these patients. The study hopes to determine if radiotherapy to the primary lung tumor can be safely delivered before the third cycle of standard systemic therapy and whether this approach is feasible for a larger phase III trial. Participants will be randomly assigned to one of two groups one receiving standard of care SoC systemic therapy alone, and the other receiving radiotherapy to the lung primary tumor prior to the third cycle of SoC systemic therapy. Radiotherapy doses vary based on tumor size and location, and systemic therapy includes chemoimmunotherapy regimens such as Pembrolizumab combined with Carboplatin, Paclitaxel, or Pemetrexed depending on the cancer subtype. Biospecimens will be collected to support future research. During the study, participants will be monitored for radiation toxicity and adverse events through scheduled visits at baseline, radiotherapy if applicable, cycle 3 of systemic therapy, and at 12 and 24 weeks after starting treatment, as well as at disease progression. CT scans will be performed every six weeks to track disease status. The primary outcome is to assess the feasibility of delivering radiotherapy as planned, while secondary outcomes include patient willingness to be randomized, safety, and progression-free survival. The total recruitment period is 18 months, with follow-up extending to 24 months.

PRIME_LUNG: Primary Radiotherapy In MEtastatic Lung Cancer - A Pilot Study