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

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ClinicalTrials.gov Identifier: NCT03215693
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

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
Non-Small Cell Lung Cancer 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 152 participants
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 : September 28, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Crizotinib

Arm Intervention/treatment
Experimental: X-396 capsule
225mg once daily
Drug: X-396 capsule
225mg once daily
Other Name: Ensartinib




Primary Outcome Measures :
  1. Objective response rate (ORR) based on independent radiology review [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 36 months ]
    PFS, defined as time from first dose of X-396 to progression or death due to any cause.

  3. Overall survival (OS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215693


Contacts
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Contact: Li Zhang, MD 020-87342288 li-zhang@csco.org.cn

Locations
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China
Beijing Cancer Hospital Recruiting
Beijing, China
Contact: Jian Fang, MD    13701224460    fangjian5555@163.com   
Principal Investigator: Jun Zhao, MD         
Beijing Chest Hospital,Capital Medical University Recruiting
Beijing, China
Contact: Shucai Zhang, MD    13901297065    sczhang6304@163.com   
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Junling Li, MD    13801178891    drlijunling@vip.163.com   
Peking Union College Hospital Recruiting
Beijing, China
Contact: Wei Zhong, MD    13810616395    zw_pumch@126.com   
Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Study Chair: Li Zhang, MD Sun Yat-sen University

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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03215693     History of Changes
Other Study ID Numbers: BTP-42322
First Posted: July 12, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Crizotinib
Ensartinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action