A Study of TQ-B3139 Capsules in Subjects With MET-Altered Advanced Non-small Cell Lung Cancer
- Registration Number
- NCT04398940
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 71
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 2. Life expectancy β₯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) β₯50%; 8. Understood and signed an informed consent form.
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- 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 β₯ 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 β₯ 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQ-B3139 capsules TQ-B3139 TQ-B3139 capsules administered orally.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) up to 18 months Percentage of subjects achieving complete response (CR) and partial response (PR).
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
Disease control rate (DCR) up to 18 months Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Intracranial objective response rate (CNS-ORR) up to 18 months Percentage of subjects achieving intracranial complete response and partial response.
Trial Locations
- Locations (16)
Anhui Provincial Hospital
π¨π³Hefei, Anhui, China
Sir Run Shaw Shaw Hospital, Zhejiang University School of Medicine
π¨π³Hangzhou, Hangzhou, China
Zhejiang Cancer Hospital
π¨π³Hangzhou, Hangzhou, China
Henan Cancer Hospital
π¨π³Zhengzhou, Henan, China
Hunan Cancer Hospital
π¨π³Changsha, Hunan, China
Shanghai Chest Hospital
π¨π³Shanghai, Shanghai, China
The Fifth Medical Center of PLA General Hospital
π¨π³Beijing, Beijing, China
Xuanwu Hospital Capital Medical University
π¨π³Beijing, Beijing, China
Beijing Cancer Hospital
π¨π³Beijing, Beijing, China
The Sixth Medical Center of PLA General Hospital
π¨π³Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
π¨π³Beijing, Beijing, China
Guangxi Medical University Affiliated Tumor Hospital
π¨π³Nanning, Guangxi Zhuang Autonomous Region, China
Jiangsu Cancer Hospital
π¨π³Nanjing, Jiangsu, China
Harbin Medical University Cancer Hospital
π¨π³Ha'erbin, Heilongjiang, China
Tianjin Medical University General Hospital
π¨π³Tianjin, Tianjin, China
Fudan University Shanghai Cancer Center
π¨π³Shanghai, Shanghai, China