NCT05341583

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.

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, randomized, placebo-controlled, multicenter, Phase III study, the primary endpoint is disease-free survival. Participants in the experimental arm will receive Ensatinib at 225 mg orally once a day taken with or without food for 2 years. Participants in the control arm will receive placebo at 225 mg orally once a day taken with or without food for 2 years. Treatments will continue until disease recurrence, meeting one of treatment discontinuation criteria (eg, patient decision, adverse event, pregnancy), or achieving a maximum treatment duration of 2 years, whichever occurs earlier. At the time of treatment discontinuation, participants will enter a survival follow-up until death, withdrawal of consent or study closure, whichever occurs earlier.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-24
• Primary completion: 2025-06-01
• Completion: 2025-07-23
• First posted: 2022-04-22
• Last updated: 2024-08-23

Locations

1 site across 1 country: China