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

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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