Efficiency and Safety of Radiotherapy Combined With Anlotinib in Locally Advanced Non-small Cell Lung Cancer Patients Intolerable to Concurrent Chemoradiotherapy: A Phase II Single-arm Trial

What this Trial Is About

Researchers are evaluating a new treatment approach for patients with locally advanced non-small cell lung cancer (LA-NSCLC) who have negative EGFR mutations and cannot tolerate concurrent chemoradiotherapy (cCRT). This phase II study aims to improve outcomes for patients receiving sequential chemoradiotherapy (sCRT) by adding an anti-angiogenesis drug called Anlotinib during the radiotherapy course. The study hypothesizes that this combination could increase the 2-year progression-free survival (PFS) rate from 35% to 50%. The study plans to enroll 44 patients. Participants will receive radiotherapy combined with oral Anlotinib. Radiotherapy may be delivered as conventional Intensity-Modulated Radiation Therapy (IMRT) with a median dose of about 60 Gy over 25 to 35 fractions, or as IMRT-based simultaneously integrated boost (SIB) with specified doses to the tumor volumes. Anlotinib treatment starts on the first day of radiotherapy at 12 mg daily for up to three cycles, each cycle lasting 2 weeks on treatment followed by 1 week off. Dose adjustments are allowed if patients experience intolerance. During the study, participants will be monitored for tumor progression, survival, local recurrence, distant metastasis, and acute toxicity. The primary outcome is 2-year progression-free survival measured from the start of radiotherapy up to 60 months. Secondary outcomes include overall survival, local regional recurrence, distant metastasis, and acute toxicity within 3 months post-radiotherapy. The total study duration includes assessments up to five years from treatment start, with safety and effectiveness evaluations ongoing throughout.

Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT