NCT04211922

Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to evaluate safety and efficacy of Alkotinib capsule in patients with ALK-positive non-small cell lung cancer previously treated with crizotinib.While exploring the relationship between biomarkers and drug efficacy and safety.

Detailed description

The drug being tested in this study is called alkotinib. Alkotinib has been demonstrated to benefit people with ALK+ NSCLC. The study is a non-control study. The study will enroll approximately 104 participants. All participants will take alkotinib 300mg throughout the study. This multi-center trial will be conducted in China. The overall time to participate in this study is 3 years. Participants will make multiple visits to the site, and 28 days after last dose of study drug for a follow-up assessment.

Conditions

• ALK-positive Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Alkotinib Capsules	Alkotinib 400mg QD

Timeline

• Start date: 2020-01-21
• Primary completion: 2022-10-11
• Completion: 2022-10-11
• First posted: 2019-12-26
• Last updated: 2024-04-26

Locations

1 site across 1 country: China