RecruitingPhase 3NCT05341583

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

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.

Sponsor

Betta Pharmaceuticals Co., Ltd.

Enrollment

202 participants

Start Date

May 24, 2022

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether ensartinib — a targeted oral drug — can reduce the chance of non-small cell lung cancer coming back after surgery in patients whose tumors have a specific gene change called ALK-positive. **You may be eligible if...** - You have had surgery to completely remove non-small cell lung cancer (R0 resection) - Your cancer is classified as stage IB through IIIB (T3N2M0) after surgery - Your tumor has been confirmed ALK-positive by a central laboratory - You have fully recovered from surgery - Your life expectancy is at least 1 year - Your ECOG performance status is 0 or 1 **You may NOT be eligible if...** - Your tumor is ALK-negative - You have not fully recovered from surgery - Your blood counts, liver, or kidney function do not meet required levels - You have incomplete (non-R0) surgical resection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEnsartinib

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

DRUGPlacebo

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

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NCT05341583

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