Phase II Study of Nintedanib with Sequential Radiotherapy to Prevent Radiation Pneumonia in Unresectable Non-Small Cell Lung Cancer

What this Trial Is About

This research aims to study patients with unresectable non-small cell lung cancer NSCLC who receive nintedanib alongside sequential radiotherapy. The study evaluates the occurrence of significant radiation pneumonitis above grade 2 and monitors the safety of combining nintedanib with radiotherapy. Additionally, the study will observe progression-free survival PFS and overall survival OS in patients treated with nintedanib plus radiotherapy and immunotherapy. Participants will first undergo induction therapy, including chemotherapy andor immunotherapy for at least one cycle. Following this, they will receive sequential radiotherapy combined with nintedanib treatment for six months. After completing this phase, patients will continue with maintenance immunotherapy for 16 cycles as part of their treatment plan. Throughout the study, participants will be monitored for safety and the incidence of radiation pneumonia for up to two years. Lung function, PFS, and OS will also be assessed during this period. The total follow-up and observation will last up to two years to evaluate these outcomes and monitor patient health comprehensively.

Nintedanib for the Prevention of Radiation Pneumonia in Unresectable NSCLC