Non-small Cell Lung Cancer
Conditions
Keywords
non-small cell lung cancer, Apatinib, S1
Brief summary
This study is to explore the potential efficacy and safety of low-dose Apatinib combined with S-1 in patients with advanced lung cancer. Patients with advanced NSCLC will be treated with oral apatinib and S-1 after treatment failure of standard regimen.
Detailed description
Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). The anti-angiogenesis effect of apatinib has been proved in preclinical tests. Phase II study has showed an improvement of progression free survival in pretreated patients. S-1, an oral fluoropyrimidine has considerable effectiveness with mild side effect in patients failed to standard treatments. The purpose of this study is to evaluate the potential efficacy and safety of low-dose Apatinib combined with S-1 in heavily pretreated patients with advanced lung cancer. And to explore the biomarkers of antiangiogenesis therapy and the possible mechanisms of treatment resistance on the basis of next generation sequencing.
Interventions
DRUGApatinib Mesylate tablet combined with S-1 capsules
Oral use with low-dose Apatinib combined with S-1 until disease progression
Sponsors
Changzhou Cancer Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed Non-small cell lung cancer * Patients with extracranial measurable lesions * Patients with NSCLC failed for standard treatments * Eastern Cooperative Oncology Group performance status score: 0\ 2 and life expectancy of more than 3 months * Major organs functioning properly * Compliance is good and agreed to cooperate with the survival of follow-up * Informed consent
Exclusion criteria
* Contraindications for investigational agents * Patients with clinical symptoms of brain metastases or meningeal metastasis * Tumor invade big vessels or close to big vessels * Uncontrolled hypertension * Abnormal coagulation (INR\>1.5 or Prothrombin Time\>ULN+4, or Activated Partial Thromboplastin Time\>1.5 ULN), bleeding tendency or receiving coagulation therapy * Hemoptysis, more than 2.5ml daily * Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis. * Myocardial ischemia or infarction more than stage II, cardiac insufficiency. * Received big surgery, had bone fracture or ulcer in 4 weeks. * Urine protein≥++, or urine protein in 24 hours≥1.0g
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival(PFS) | 2 years | PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival(OS) | 2 years | Overall Survival is defined as the length of time from random assignment to death or to last contact. |
| Objective response rate(ORR) | 2 years | Objective response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1） |
| Disease Control Rate(DCR) | 2 years | Disease Control Rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease according to radiological assessments. |
| Adverse Events(AEs) | 2 years | AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0. |
Countries
China
Outcome results
None listed