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

September 10, 2020 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

71

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100021
        • Not yet recruiting
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Junling Li, Doctor
      • Beijing, Beijing, China, 100142
        • Not yet recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Jian Fang
          • Phone Number: 010-88196479
      • Beijing, Beijing, China, 100071
        • Not yet recruiting
        • The Fifth Medical Center of PLA General Hospital
        • Contact:
        • Principal Investigator:
          • Hong Wang, Doctor
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
        • Principal Investigator:
          • Yi Zhang, Doctor
        • Contact:
      • Beijing, Beijing, China, 100010
        • Not yet recruiting
        • The Sixth Medical Center of PLA General Hospital
        • Principal Investigator:
          • Zhihai Han, Doctor
        • Contact:
    • Guangxi Zhuang Autonomous Region
      • Nanning, Guangxi Zhuang Autonomous Region, China, 530021
        • Not yet recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
    • Hangzhou
      • Hangzhou, Hangzhou, China, 310016
        • Not yet recruiting
        • Sir Run Shaw Shaw Hospital, Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Kejing Ying, Doctor
      • Hangzhou, Hangzhou, China, 310022
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Xinmin Yu
        • Contact:
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • Harbin medical university cancer hospital
        • Contact:
        • Principal Investigator:
          • Gongyan Chen, Doctor
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Not yet recruiting
        • Henan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Qiming Wang, Doctor
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Hunan Cancer hospital
        • Principal Investigator:
          • Jianhua Chen, Doctor
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Not yet recruiting
        • Jiangsu Cancer Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
          • Baohui Han, Doctor
          • Phone Number: 021-22200000
        • Principal Investigator:
          • Baohui Han, Doctor
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Jialei WANG
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300041
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Diansheng Zhong, Doctor
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQ-B3139 capsules
TQ-B3139 capsules administered orally.
Drug: TQ-B3139
TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: up to 18 months
Percentage of subjects achieving complete response (CR) and partial response (PR).
up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: up to 18 months
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.
up to 18 months
Disease control rate (DCR)
Time Frame: up to 18 months
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 18 months
Overall survival (OS)
Time Frame: up to 24 months
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.
up to 24 months
Duration of Response (DOR)
Time Frame: up to 18 months
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
up to 18 months
Intracranial progression-free survival (CNS-PFS)
Time Frame: up to 18 months
The time from enrollment to the first confirmed intracranial progression for brain metastases.
up to 18 months
Intracranial objective response rate (CNS-ORR)
Time Frame: up to 18 months
Percentage of subjects achieving intracranial complete response and partial response.
up to 18 months
Time to progress of intracranial disease (CNS-TTP)
Time Frame: up to 18 months
The time from the first dose to the first occurrence of intracranial disease progression.
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2020

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

September 11, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ-B3139-II-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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