NCT07235306

Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC

Ensartinib for the Treatment of Patients With ALK-Mutated Stage III Unresectable NSCLC: A Multicenter, Randomized Controlled, Double-blind Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NSCLC Stage III
• Ensartinib
• Chemoradiotherapy
• ALK

Interventions

Type	Name	Description
DRUG	Ensartinib 225mg	225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met
DRUG	Placebo Ensartinib 225mg	225mg once daily, until disease progression, unacceptable toxicity or other discontinuation criteria are met

Timeline

• Start date: 2025-12-01
• Primary completion: 2031-01-31
• Completion: 2031-12-31
• First posted: 2025-11-19
• Last updated: 2025-11-19