Study of Alectinib Combined With Consolidation Radiation Therapy for Advanced ALK-Positive Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of adding radiation therapy to all tumor lesions alongside first-line treatment with alectinib in patients with advanced non-small cell lung cancer NSCLC that has ALK gene rearrangements. This phase III trial aims to determine if this combination is safe and whether it can delay disease progression in patients who have responded to initial alectinib treatment. Participants first receive 2-3 months of alectinib treatment. Those showing stable disease or partial response then undergo consolidation radiation therapy to all known active tumor lesions using stereotactic body radiation therapy SBRT, stereotactic radiosurgery SRS, or moderately hypofractionated radiation therapy while continuing alectinib. Treatment continues until disease progression, unacceptable side effects, or other criteria require stopping. During the study, participants are closely monitored for safety and treatment effects. Researchers assess toxicity up to 6 months after radiation and track progression-free survival at 12 months after starting alectinib. Other outcomes include overall survival, time to treatment failure, and time to next therapy over several years. Patients undergo imaging scans, laboratory tests, and clinical evaluations throughout their participation, which may last several years depending on outcomes.

Alectinib Followed by Concomitant Consolidation Radiation Therapy in Advanced NSCLC With ALK-rearrangement (A-SAB)