Clinical Trial

Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC

Not Yet Recruiting Phase 2
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Summary
The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). However, its benefit is limited in patients with driver gene mutations. The LAURA study established a new paradigm of targeted consolidation therapy after CRT for patients with EGFR mutations. Although retrospective data support the efficacy of ALK-TKIs, no randomized controlled trial (RCT) has clearly demonstrated the value of ALK-TKI maintenance therapy after CRT. This study adopts a multicenter, randomized, double-blind, placebo-controlled design aimed at evaluating the efficacy and safety of ensartinib in patients with ALK-positive unresectable stage III NSCLC.
Trial Details
NCT Number NCT07235306
Lead Sponsor Shanghai Pulmonary Hospital, Shanghai, China
Conditions NSCLC Stage III, Ensartinib, Chemoradiotherapy, ALK
Enrollment 45 participants
Start Date 2025-12-01
Primary Completion 2031-01-31 (estimated)
Study Completion 2031-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-19