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A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TQ-B3139
Sponsored by
Chia Tai Tianqing Pharmaceutical Group 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:

  • 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 2. Life expectancy ≥12 weeks; 3. MET-altered non-small cell lung cancer (NSCLC) ; 4. Has at least one measurable lesion; 5. Previous standard treatment has failed; 6. Adequate organ system function; 7. Left ventricular ejection fraction (LVEF) ≥50%; 8. Understood and signed an informed consent form.

Exclusion Criteria:

  • 1. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 2. Has received c-MET inhibitors; 3. Has received other system anti-tumor treatment within 4 weeks before the first administration; 4. Has received major surgical treatment within 4 weeks before the first administration; 5. Has received radiotherapy or any surgery within 2 weeks before the first administration; 6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy; 7. Has active infection within 2 weeks before the first administration; 8. Has currently uncontrollable congestive heart failure; 9. Has currently uncontrollable congestive heart failure; 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms; 11. Has uncontrollable effusion; 12. Has interstitial lung diseases; 13. Has severely unstable central nervous system metastasis; 14. Has active viral infection; 15. Has multiple factors affecting oral medication; 16. Breastfeeding or pregnant women; Men unwilling to use adequate contraceptive measures during the study; 17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sites / Locations

  • Anhui Provincial Hospital
  • The Sixth Medical Center of PLA General Hospital
  • Cancer Hospital Chinese Academy of Medical Sciences
  • Xuanwu Hospital Capital Medical UniversityRecruiting
  • The Fifth Medical Center of PLA General Hospital
  • Beijing Cancer Hospital
  • Guangxi Medical University Affiliated Tumor Hospital
  • Sir Run Shaw Shaw Hospital, Zhejiang University School of Medicine
  • Zhejiang Cancer Hospital
  • Harbin Medical University Cancer Hospital
  • Henan Cancer Hospital
  • Hunan Cancer Hospital
  • Jiangsu Cancer Hospital
  • Shanghai Chest HospitalRecruiting
  • Fudan University Shanghai Cancer Center
  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TQ-B3139 capsules

Arm Description

TQ-B3139 capsules administered orally.

Outcomes

Primary Outcome Measures

Objective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).

Secondary Outcome Measures

Progression-free survival (PFS)
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
Disease control rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Intracranial progression-free survival (CNS-PFS)
The time from enrollment to the first confirmed intracranial progression for brain metastases.
Intracranial objective response rate (CNS-ORR)
Percentage of subjects achieving intracranial complete response and partial response.
Time to progress of intracranial disease (CNS-TTP)
The time from the first dose to the first occurrence of intracranial disease progression.

Full Information

First Posted
May 19, 2020
Last Updated
September 10, 2020
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04398940
Brief Title
A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
Official Title
A Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of TQ-B3139 in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
January 31, 2022 (Anticipated)
Study Completion Date
October 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

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

5. Study Description

Brief Summary
This is a single-arm, multi-center clinical trial to evaluate the safety and efficacy of TQ-B3139 capsules in patients with MET gene abnormal advanced non-small cell lung cancer.

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
71 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TQ-B3139 capsules
Arm Type
Experimental
Arm Description
TQ-B3139 capsules administered orally.
Intervention Type
Drug
Intervention Name(s)
TQ-B3139
Intervention Description
TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Percentage of subjects achieving complete response (CR) and partial response (PR).
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause.
Time Frame
up to 18 months
Title
Disease control rate (DCR)
Description
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time Frame
up to 18 months
Title
Overall survival (OS)
Description
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Time Frame
up to 24 months
Title
Duration of Response (DOR)
Description
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time Frame
up to 18 months
Title
Intracranial progression-free survival (CNS-PFS)
Description
The time from enrollment to the first confirmed intracranial progression for brain metastases.
Time Frame
up to 18 months
Title
Intracranial objective response rate (CNS-ORR)
Description
Percentage of subjects achieving intracranial complete response and partial response.
Time Frame
up to 18 months
Title
Time to progress of intracranial disease (CNS-TTP)
Description
The time from the first dose to the first occurrence of intracranial disease progression.
Time Frame
up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 2. Life expectancy ≥12 weeks; 3. MET-altered non-small cell lung cancer (NSCLC) ; 4. Has at least one measurable lesion; 5. Previous standard treatment has failed; 6. Adequate organ system function; 7. Left ventricular ejection fraction (LVEF) ≥50%; 8. Understood and signed an informed consent form. Exclusion Criteria: 1. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 2. Has received c-MET inhibitors; 3. Has received other system anti-tumor treatment within 4 weeks before the first administration; 4. Has received major surgical treatment within 4 weeks before the first administration; 5. Has received radiotherapy or any surgery within 2 weeks before the first administration; 6. Acute toxicity that is ≥ Grade 2 caused by previous cancer therapy; 7. Has active infection within 2 weeks before the first administration; 8. Has currently uncontrollable congestive heart failure; 9. Has currently uncontrollable congestive heart failure; 10. Has continuous arrhythmia ≥ Grade 2, uncontrollable atrial fibrillation or QTc interval > 480ms; 11. Has uncontrollable effusion; 12. Has interstitial lung diseases; 13. Has severely unstable central nervous system metastasis; 14. Has active viral infection; 15. Has multiple factors affecting oral medication; 16. Breastfeeding or pregnant women; Men unwilling to use adequate contraceptive measures during the study; 17. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baohui Han, Doctor
Phone
021-22200000
Email
18930858216@163.com
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueyin Pan, Doctor
Phone
0551-2283114
Email
yueyinpan1965@126.com
First Name & Middle Initial & Last Name & Degree
Yueyin Pan, Doctor
Facility Name
The Sixth Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100010
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihai Han, Doctor
Phone
010-66957581
Email
hanzhihai@souhu.com
First Name & Middle Initial & Last Name & Degree
Zhihai Han, Doctor
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junling Li, Doctor
Phone
010-87788713
Email
drlijunling@vip.163.com
First Name & Middle Initial & Last Name & Degree
Junling Li, Doctor
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhang, Doctor
Phone
010-83192232
Email
steven9130@sina.com
First Name & Middle Initial & Last Name & Degree
Yi Zhang, Doctor
Facility Name
The Fifth Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Wang, Doctor
Phone
010-66947163
Email
18611707961@163.com
First Name & Middle Initial & Last Name & Degree
Hong Wang, Doctor
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Fang
Phone
010-88196479
First Name & Middle Initial & Last Name & Degree
Jian Fang
Facility Name
Guangxi Medical University Affiliated Tumor Hospital
City
Nanning
State/Province
Guangxi Zhuang Autonomous Region
ZIP/Postal Code
530021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qitao Yu
Phone
0771-5328331
Email
yqt178@163.com
First Name & Middle Initial & Last Name & Degree
Qitao Yu
Facility Name
Sir Run Shaw Shaw Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Hangzhou
ZIP/Postal Code
310016
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kejing Ying, Doctor
Phone
0571-86006192
Email
yingsrrsh@163.com
First Name & Middle Initial & Last Name & Degree
Kejing Ying, Doctor
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinmin Yu
Phone
0571-88122084
Email
yuxm@zjcc.org.cn
First Name & Middle Initial & Last Name & Degree
Xinmin Yu
Facility Name
Harbin Medical University Cancer Hospital
City
Ha'erbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gongyan Chen, Doctor
Phone
0451-86298265
Email
chengongyan@163.com
First Name & Middle Initial & Last Name & Degree
Gongyan Chen, Doctor
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiming Wang, Doctor
Phone
400-0371-818
Email
qimingwang1006@126.com
First Name & Middle Initial & Last Name & Degree
Qiming Wang, Doctor
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Chen, Doctor
Phone
0731-89762220
Email
cjh_1000@163.com
First Name & Middle Initial & Last Name & Degree
Jianhua Chen, Doctor
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiqi Shi
Phone
025-83283568
Email
shimeiqi1963@163.com
First Name & Middle Initial & Last Name & Degree
Meiqi Shi
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baohui Han, Doctor
Phone
021-22200000
First Name & Middle Initial & Last Name & Degree
Baohui Han, Doctor
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jialei Wang
Email
luwangjialei@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jialei Wang
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diansheng Zhong, Doctor
Phone
022-60817007
Email
zhongdsh@hotmail.com
First Name & Middle Initial & Last Name & Degree
Diansheng Zhong, Doctor

12. IPD Sharing Statement

Learn more about this trial

A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer

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