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

Betta Pharmaceuticals

Status and phase

Active, not recruiting

Phase 2

Conditions

Non-Small Cell Lung Cancer

Treatments

Drug: X-396 capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT03215693

BTP-42322

Details and patient eligibility

About

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.

Full description

This is a phase II, multicenter, single-arm study in which the safety and efficacy of X-396(Ensartinib) will be assessed in adult Chinese patients with ALK-positive(rearrangement) non-small cell lung cancer previously treated with crizotinib. Approximately 144 patients with locally advanced or metastatic NSCLC which carry ALK -rearrangement will be enrolled in the study.

Enrollment

152 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.