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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
Anhui Provincial Hospital
Hefei, Anhui, China
NOT_YET_RECRUITINGObjective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) and partial response (PR).
Time frame: up to 18 months
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.
Time frame: up to 18 months
Disease control rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 18 months
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.
Time frame: up to 24 months
Duration of Response (DOR)
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
Intracranial progression-free survival (CNS-PFS)
The time from enrollment to the first confirmed intracranial progression for brain metastases.
Time frame: up to 18 months
Intracranial objective response rate (CNS-ORR)
Percentage of subjects achieving intracranial complete response and partial response.
Time frame: up to 18 months
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The Sixth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGXuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGThe Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGBeijing Cancer Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGGuangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
NOT_YET_RECRUITINGSir Run Shaw Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Hangzhou, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, Hangzhou, China
NOT_YET_RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
NOT_YET_RECRUITING...and 6 more locations
Time to progress of intracranial disease (CNS-TTP)
The time from the first dose to the first occurrence of intracranial disease progression.
Time frame: up to 18 months