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NOT YET RECRUITING
NCT07235306
PHASE2

Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-12-01

Completion Date

2031-12-31

Last Updated

2025-11-19

Healthy Volunteers

No

Interventions

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