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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3139 capsules | Experimental | TQ-B3139 capsules administered orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3139 | Drug | TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Percentage of subjects achieving complete response (CR) and partial response (PR). | up to 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baohui Han, Doctor | Contact | 021-22200000 | 18930858216@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | 230000 | China |
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Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
| 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. | 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. | up to 18 months |
| Intracranial progression-free survival (CNS-PFS) | The time from enrollment to the first confirmed intracranial progression for brain metastases. | up to 18 months |
| Intracranial objective response rate (CNS-ORR) | Percentage of subjects achieving intracranial complete response and partial response. | up to 18 months |
| 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 |
| The Sixth Medical Center of PLA General Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100010 | China |
|
| Cancer Hospital Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | Beijing Municipality | 100021 | China |
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| Xuanwu Hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| The Fifth Medical Center of PLA General Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100071 | China |
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| Beijing Cancer Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Guangxi Medical University Affiliated Tumor Hospital | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| Sir Run Shaw Shaw Hospital, Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Hangzhou | 310016 | China |
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| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Hangzhou | 310022 | China |
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| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450008 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410013 | China |
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| Jiangsu Cancer Hospital | Not yet recruiting | Nanjing | Jiangsu | 210009 | China |
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| Shanghai Chest Hospital | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Fudan University Shanghai Cancer Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Tianjin Medical University General Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300041 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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