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

ALK-positive Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04211922
• Other study ID #: ZGALK002
• Status: Terminated
• Phase: Phase 2
• Start date: January 21, 2020
• Est. completion date: October 11, 2022

Study information

• Verified date: April 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 11, 2022
• Est. primary completion date: October 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ALK-positive Non-small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• Alkotinib Capsules
Alkotinib 400mg QD

Locations

Country	Name	City	State
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR) based on independent radiology review	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).	24 months
Secondary	Progression-free survival (PFS) as assessed by independent radiology review and investigator	PFS, defined as time from first dose of Alkotinib to progression or death due to any cause.	36 months
Secondary	Overall survival (OS)	OS, defined as time from first dose of Alkotinib to death due to any cause	36 months