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

Zelgen Biopharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: ALK-positive Non-small Cell Lung Cancer

Treatments: Drug: Alkotinib Capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT04211922

ZGALK002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

Alkotinib 400mg QD

Experimental group

Description:

400mg orally once daily. Take Alkotinib at least 1 hour before or at least 2 hours after a meal.

Treatment:

Drug: Alkotinib Capsules