X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is to evaluate safety and efficacy of X-396(Ensartinib) 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: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.
• Treatments: Crizotinib; Ensartinib

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer.

• 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

• Measurable disease by response evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1).

• Asymptomatic CNS metastases do not require the use of steroids or anticonvulsants.

• Willingness and ability to comply with the trial and follow-up procedures.

• Ability to understand the nature of this trial and give written informed consent.

Exclusion Criteria:

• Prior use of ALK TKIs with the exception of crizotinib.

• Patients currently receiving cancer system therapy.

• Use of an investigational drug within 4 weeks prior to the first dose of study drug.

• Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.

• Patients with a known allergy or delayed hypersensitivity reaction to drugs.