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Apatinib is a new kind of selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor (TKI). The investigators have finished the preclinical,phase I and phase II clinical studies and found its promising anti-tumor activity and tolerable toxicities. A disease-control rate of 61.1% and a mPFS of 4.7 months were showed in apatinib phase II study in patients with NSCLC.
The study aims to compare the efficacy and safety of apatinib to placebo in advanced non-squamous non-small cell lung cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib | Experimental | Apatinib tablet administered orally, 750 mg,once daily until progression |
|
| Placebo | Placebo Comparator | Placebo tablet administered orally, once a day until progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival(OS) | Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause.The date the patient was recorded alive of last follow-up.Median time results from unstratified Kaplan-Meier estimates. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). | 24 months |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunjiang Yu | Contact | +86-021-68868768 | yushunjiang@hrs.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, Cancer Center, Sun Yet-sen University | Recruiting | Guangzhou | Guangdong | 510060 | China |
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ORR was defined as the proportion of patients whose best response was Complete Response [CR: disappearance of all clinical and radiological evidence of tumor (both target and non-target)] or Partial Response [PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD] over the whole duration of study. |
| 24 months |
| Duration of response (DoR) | DoR was defined as the time from documentation of tumor response to disease progression. | 24 months |
| Disease control rate (DCR) | DCR was defined as the proportion of patients whose best response was CR or PR or Stable Disease (SD) | 24 months |
| Mean Change From Baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) | 24 months |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| 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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| ID | Term |
|---|---|
| C553458 | apatinib |
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