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

Phase 2TerminatedNCT04211922

Suzhou Zelgen Biopharmaceuticals Co.,Ltd4 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ALK-positive Non-small Cell Lung Cancer

Interventions

Alkotinib CapsulesDRUG

Alkotinib 400mg QD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

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).

Time frame: 24 months

Secondary Outcomes

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.

Time frame: 36 months

Overall survival (OS)

OS, defined as time from first dose of Alkotinib to death due to any cause

Time frame: 36 months

Data from ClinicalTrials.gov

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