Clinical Trials /

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

NCT03215693

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: BTP-42322
  • NCT ID: NCT03215693

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
X-396 capsuleEnsartinibX-396 capsule

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
X-396 capsuleExperimental225mg once daily
  • X-396 capsule

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) based on independent radiology review
Time Frame:24 months
Safety Issue:
Description: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).

Secondary Outcome Measures

Measure:ORR based on investigator assessment
Time Frame:24 months
Safety Issue:
Description: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).
Measure:Progression-free survival (PFS) as assessed by independent radiology review and investigator
Time Frame:36 months
Safety Issue:
Description:PFS, defined as time from first dose of X-396 to progression or death due to any cause.
Measure:Overall survival (OS)
Time Frame:36 months
Safety Issue:
Description:OS, defined as time from first dose of X-396 to death due to any cause.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Betta Pharmaceuticals Co.,Ltd.

Last Updated

December 19, 2017