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

Phase 2

Terminated

• Conditions: ALK-positive Non-small Cell Lung Cancer
• Interventions: Drug: Alkotinib Capsules

• Registration Number: NCT04211922
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief 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.

Study Timeline

• Study First Submitted: 2019-12-23
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-26
• Study Start: 2020-01-21
• Primary Completion: 2022-10-11
• Study Completion: 2022-10-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Evidence of positive ALK.
• Patients must have demonstrated progression during or after crizotinib treatment.
• Age 18 years or older at the time of informed consent.
• Eastern cooperative oncology group performance status (ECOG PS) of 0-2
• At least one measurable lesion by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).
• Willingness and ability to comply with the trial and follow-up procedures.

Exclusion Criteria

• chemotherapy, radiation therapy, immunotherapy within 4 weeks.
• Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
• Uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alkotinib 400mg QD	Alkotinib Capsules	400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR) based on independent radiology review	24 months	ORR per RECIST 1.1 calculated as the proportion of patients with a best overall response defined as complete response (CR) or partial response (PR).

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	36 months	OS, defined as time from first dose of Alkotinib to death due to any cause
Progression-free survival (PFS) as assessed by independent radiology review and investigator	36 months	PFS, defined as time from first dose of Alkotinib to progression or death due to any cause.

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China