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RECRUITING
NCT05341583
PHASE3

Ensartinib as Adjuvant Treatment in Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer

Sponsor: Betta Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

This double-blind, randomized, placebo-controlled, multicenter, Phase III study is designed to evaluate the efficacy and safety of ensatinib compared with placebo as adjuvant treatment in ALK positive stage II-IIIB non-small cell lung cancer after surgical resection with or without chemotherapy.

Official title: A Phase Ⅲ, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of Ensartinib Versus Placebo as Adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Stage IB- IIIB Non-small Cell Lung Cancer.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

202

Start Date

2022-05-24

Completion Date

2025-07-23

Last Updated

2024-08-23

Healthy Volunteers

No

Interventions

DRUG

Ensartinib

Ensartinib 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.

DRUG

Placebo

Placebo 225 mg once daily until disease recurrence or up to 2 years, whichever occurs earlier.

Locations (1)

TianJin Medical University Cancer Institute & Hospital

Tianjin, China