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Apatinib is a new kind of Vascular endothelial growth factor receptor(VEGFR) tyrosine kinase inhibitors (TKIs). The investigators have finished the preclinical and phase I and phase II clinical study for apatinib and found its satisfactory anti-tumor activity and tolerated toxicities. A disease-control rate of 75% was found in lung cancer patients. In the present phase III trial, the investigators will further evaluate the efficacy and toxicities of apatinib in the treatment of advanced non-squamous non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apatinib | Experimental | 750 mg,po,QD; 28 days every cycle |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib | Drug | 750 mg,po,QD; 28 days every cycle |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Progression-free survival as the time from randomization to documented disease progression according to response evaluation criteria in solid tumors (RECIST) or death. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | ORR was the percentage of patients who got partial or complete response | 24 months |
| Overall Survival(OS) | OS was determined from date of enrollment until death or the date the patient was recorded alive of last follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, MD | Cancer Center of Sun Yat-Sen University (CCSU) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of Sun Yat-Sen University (CCSU) | Guangzhou | Guangdong | 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 |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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| Drug |
po,QD; 28 days every cycle |
|
| 24 months |
| Toxicity | Adverse events (AEs) were recorded, graded for toxicity using the NCI-CTC, and assessed by the investigator for any relationship with treatment. | 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |