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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04398940

Collaborator

(none)

Enrollment

Locations

Arm

26.6

Anticipated Duration (Months)

4.4

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Drug: TQ-B3139	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

71 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 11, 2020

Anticipated Primary Completion Date :

Jan 31, 2022

Anticipated Study Completion Date :

Oct 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Objective Response Rate (ORR) [up to 18 months]
Percentage of subjects achieving complete response (CR) and partial response (PR).

Secondary Outcome Measures

Progression-free survival (PFS) [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.
Disease control rate (DCR) [up to 18 months]
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Overall survival (OS) [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.
Duration of Response (DOR) [up to 18 months]
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) [up to 18 months]
The time from enrollment to the first confirmed intracranial progression for brain metastases.
Intracranial objective response rate (CNS-ORR) [up to 18 months]
Percentage of subjects achieving intracranial complete response and partial response.
Time to progress of intracranial disease (CNS-TTP) [up to 18 months]
The time from the first dose to the first occurrence of intracranial disease progression.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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;

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Provincial Hospital	Hefei	Anhui	China	230000
2	The Sixth Medical Center of PLA General Hospital	Beijing	Beijing	China	100010
3	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021
4	Xuanwu Hospital Capital Medical University	Beijing	Beijing	China	100053
5	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing	China	100071
6	Beijing Cancer Hospital	Beijing	Beijing	China	100142
7	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi Zhuang Autonomous Region	China	530021
8	Sir Run Shaw Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Hangzhou	China	310016
9	Zhejiang Cancer Hospital	Hangzhou	Hangzhou	China	310022
10	Harbin Medical University Cancer Hospital	Ha'erbin	Heilongjiang	China	150000
11	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
12	Hunan Cancer Hospital	Changsha	Hunan	China	410013
13	Jiangsu Cancer Hospital	Nanjing	Jiangsu	China	210009
14	Shanghai Chest Hospital	Shanghai	Shanghai	China	200030
15	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032
16	Tianjin Medical University General Hospital	Tianjin	Tianjin	China	300041

Sponsors and Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04398940

Other Study ID Numbers:

TQ-B3139-II-02

First Posted:

May 22, 2020

Last Update Posted:

Sep 11, 2020

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Sep 11, 2020