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

• Status: Recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Treatments: Crizotinib

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