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

Sponsor
Betta Pharmaceuticals Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03215693
Collaborator
(none)
152
Enrollment
4
Locations
1
Arm
14.1
Anticipated Duration (Months)
38
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: X-396 capsule
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
152 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 28, 2017
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: X-396 capsule

225mg once daily

Drug: X-396 capsule
225mg once daily
Other Names:
  • Ensartinib

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) based on independent radiology review [24 months]

      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

    1. ORR based on investigator assessment [24 months]

      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).

    2. Progression-free survival (PFS) as assessed by independent radiology review and investigator [36 months]

      PFS, defined as time from first dose of X-396 to progression or death due to any cause.

    3. Overall survival (OS) [36 months]

      OS, defined as time from first dose of X-396 to death due to any cause.

    Other Outcome Measures

    1. Overall intracranial response rate (OIRR) by independent radiology review and investigator assessment [24 months]

      OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline.

    2. Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire [24 months]

      Time to deterioration (TTD) is defined at the time from date of randomization to a worsening of at least 10 points (on a 100 point scale) in each item score of the EORTC C30/LC13

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Cancer Hospital Beijing China
    2 Beijing Chest Hospital，Capital Medical University Beijing China
    3 Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences Beijing China
    4 Peking Union College Hospital Beijing China

    Sponsors and Collaborators

    • Betta Pharmaceuticals Co., Ltd.

    Investigators

    • Study Chair: Li Zhang, MD, Sun Yat-sen University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Betta Pharmaceuticals Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03215693
    Other Study ID Numbers:
    • BTP-42322
    First Posted:
    Jul 12, 2017
    Last Update Posted:
    Dec 21, 2017
    Last Verified:
    Dec 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Ensartinib

    Study Results

    No Results Posted as of Dec 21, 2017