Brief Title
X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Official Title
A Phase II, Multicenter, Single-arm Study to Evaluate Safety and Efficacy of X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Brief 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.
Detailed 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate (ORR) based on independent radiology review
Secondary Outcome
ORR based on investigator assessment
Condition
Non-Small Cell Lung Cancer
Intervention
X-396 capsule
Study Arms / Comparison Groups
X-396 capsule
Description: 225mg once daily
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
152
Start Date
September 28, 2017
Completion Date
December 2018
Primary Completion Date
September 2018
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Li Zhang, MD, 020-87342288, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03215693
Organization ID
BTP-42322
Responsible Party
Sponsor
Study Sponsor
Betta Pharmaceuticals Co., Ltd.
Study Sponsor
Li Zhang, MD, Study Chair, Sun Yat-sen University
Verification Date
December 2017