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

Primary Purpose

Non-Small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
X-396 capsule
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Cancer Hospital
  • Beijing Chest Hospital，Capital Medical University
  • Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
  • Peking Union College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

X-396 capsule

Arm Description

225mg once daily

Outcomes

Primary Outcome Measures

Objective response rate (ORR) based on independent radiology review
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

ORR based on investigator assessment
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
PFS, defined as time from first dose of X-396 to progression or death due to any cause.
Overall survival (OS)
OS, defined as time from first dose of X-396 to death due to any cause.

Full Information

First Posted
July 11, 2017
Last Updated
August 15, 2023
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03215693
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
X-396 capsule
Arm Type
Experimental
Arm Description
225mg once daily
Intervention Type
Drug
Intervention Name(s)
X-396 capsule
Other Intervention Name(s)
Ensartinib
Intervention Description
225mg once daily
Primary Outcome Measure Information:
Title
Objective response rate (ORR) based on independent radiology review
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
ORR based on investigator assessment
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).
Time Frame
24 months
Title
Progression-free survival (PFS) as assessed by independent radiology review and investigator
Description
PFS, defined as time from first dose of X-396 to progression or death due to any cause.
Time Frame
36 months
Title
Overall survival (OS)
Description
OS, defined as time from first dose of X-396 to death due to any cause.
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Overall intracranial response rate (OIRR) by independent radiology review and investigator assessment
Description
OIRR calculated as the ORR (CR+PR) of lesions in the brain for patients who have measureable disease in the brain at baseline.
Time Frame
24 months
Title
Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire
Description
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhang, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Beijing Chest Hospital，Capital Medical University
City
Beijing
Country
China
Facility Name
Department of Medical Oncology, Cancer Institute/Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Facility Name
Peking Union College Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31628085
Citation
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.
Results Reference
derived

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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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