Brief Title
Alkotinib Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
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
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate (ORR) based on independent radiology review
Secondary Outcome
Progression-free survival (PFS) as assessed by independent radiology review and investigator
Condition
ALK-positive Non-small Cell Lung Cancer
Intervention
Alkotinib Capsules
Study Arms / Comparison Groups
Alkotinib 400mg QD
Description: 400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
104
Start Date
January 20, 2020
Completion Date
August 30, 2022
Primary Completion Date
June 30, 2022
Eligibility Criteria
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 lension 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Caicun Zhou, Doctor, 021-65115006, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT04211922
Organization ID
ZGALK002
Responsible Party
Sponsor
Study Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study Sponsor
Caicun Zhou, Doctor, Study Chair, Shanghai Pulmonary Hospital, Shanghai, China
Verification Date
July 2020