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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03215693
Recruitment Status : Unknown
Verified December 2017 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 12, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE July 11, 2017
First Posted Date  ICMJE July 12, 2017
Last Update Posted Date December 21, 2017
Actual Study Start Date  ICMJE September 28, 2017
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2017)
  • 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).
  • 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.
  • Overall survival (OS) [ Time Frame: 36 months ]
    OS, defined as time from first dose of X-396 to death due to any cause.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 11, 2017)
  • 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.
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE X-396 Capsule in Patients With ALK-positive Non-small Cell Lung Cancer Previously Treated With Crizotinib
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Small Cell Lung Cancer
Intervention  ICMJE Drug: X-396 capsule
225mg once daily
Other Name: Ensartinib
Study Arms  ICMJE Experimental: X-396 capsule
225mg once daily
Intervention: Drug: X-396 capsule
Publications * Yang Y, Zhou J, Zhou J, Feng J, Zhuang W, Chen J, Zhao J, Zhong W, Zhao Y, Zhang Y, Song Y, Hu Y, Yu Z, Gong Y, Chen Y, Ye F, Zhang S, Cao L, Fan Y, Wu G, Guo Y, Zhou C, Ma K, Fang J, Feng W, Liu Y, Zheng Z, Li G, Wu N, Song W, Liu X, Zhao S, Ding L, Mao L, Selvaggi G, Yuan X, Fu Y, Wang T, Xiao S, Zhang L. Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial. Lancet Respir Med. 2020 Jan;8(1):45-53. doi: 10.1016/S2213-2600(19)30252-8. Epub 2019 Oct 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 19, 2017)
152
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2017)
144
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03215693
Other Study ID Numbers  ICMJE BTP-42322
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Betta Pharmaceuticals Co., Ltd.
Study Sponsor  ICMJE Betta Pharmaceuticals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Li Zhang, MD Sun Yat-sen University
PRS Account Betta Pharmaceuticals Co., Ltd.
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP