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

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 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

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 2021