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Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC

NCT07235306 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-11-19

No results posted yet for this study

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

  • ALK
  • NSCLC Stage III
  • Ensartinib
  • Chemoradiotherapy

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

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2031-01-31
Completion
2031-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07235306 on ClinicalTrials.gov