Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2) and also represents mild inhibition to PDGFR, c-Kit and c-src tyrosine kinases. It is an orally bioavailable, small molecule agent which is thought to inhibit VEGF-mediated endothelial cell migration and proliferation thus blocking blood vessel formation in tumor tissues. Previous studies have identified that apatinib was well tolerated at doses below 750mg daily. In phase I/II study, investigators reported an objective response rate of 68%. In a phase III trial conducted in advanced pretreated gastric cancer, the median overall survival was significantly prolonged in the apatinib group compared with placebo group. Thus, in this trial, the investigators aim to investigate the efficacy and safety of apatinib in previously treated advanced non-squamous non-small cell lung cancer.
Observing the efficacy and safety of apatinib in heavily treated non-squamous non-small cell lung cancer.
Primary Outcome Measure: Objective Response Rate Secondary Outcome Measures: Progression free survival, overall survival, Side effects, Quality Of Life
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib single agent | Experimental | apatinib, single agent, 500mg or 750mg Qd po, continue until disease progression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| apatinib single agent | Drug | For those heavily treated non-squamous non-small cell lung cancer, treat with apatinib single agent, 500mg or 750mg Qd, p.o based on the status of patient, continue until disease progression, dose reduction was admitted |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | To evaluate Objective response rate every 6-8 weeks after the initiation of apatinib. | tumor assessment every 2 cycles after the initiation of apatinib,up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | PFS is evaluated in 24 months since the treatment began | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | evaluated in the 24th month since the treatment began | 12 months |
| side effects | evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
Inclusion Criteria:
7. Organ functions normal, as defined below, within two weeks of randomization: Hb≥90g/L Absolute neutrophils count(ANC)≥1.5×109/L Platelets≥80×109/L Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT)≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥45ml/min or Cr≤1.25×ULN 8. Females of child-bearing potential must have negative serum pregnancy test. Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| caicun zhou, MD,PhD | Shanghai Pulmonary Hospital, Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Shanghai pulmonary hospital | Shanghai | 200433 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30026059 | Derived | Wu F, Zhang S, Xiong A, Gao G, Li W, Cai W, Su C, Chen X, Zhou F, Zhao J, Ren S, Zhou C. A Phase II Clinical Trial of Apatinib in Pretreated Advanced Non-squamous Non-small-cell Lung Cancer. Clin Lung Cancer. 2018 Nov;19(6):e831-e842. doi: 10.1016/j.cllc.2018.06.002. Epub 2018 Jun 27. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C553458 | apatinib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 12 months |
| Quality of life | evaluated in the 24th month since the treatment began | 12 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |