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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04398940
• Other study ID #: TQ-B3139-II-02
• Status: Recruiting
• Phase: Phase 2
• Start date: August 11, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Baohui Han, Doctor
• Phone: 021-22200000
• Email: 18930858216[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Est. completion date: October 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• TQ-B3139
TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing
China	The Sixth Medical Center of PLA General Hospital	Beijing	Beijing
China	Xuanwu Hospital Capital Medical University	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Harbin Medical University Cancer Hospital	Ha'erbin	Heilongjiang
China	Sir Run Shaw Shaw Hospital, Zhejiang University School of Medicine	Hangzhou	Hangzhou
China	Zhejiang Cancer Hospital	Hangzhou	Hangzhou
China	Anhui Provincial Hospital	Hefei	Anhui
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi Zhuang Autonomous Region
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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