Lung Cancer
Conditions
Brief summary
Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.
Detailed description
Lung adenocarcinoma is the most common NSCLC,most patient were diagnosed to advanced stage.The first-line therapy include chemotherapy of targeted therapy .Tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant EGFR patients.However,the benefit lasted for about 6-8 months.So we consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients.We designed the study to find out whether the addition of apatinib to the Tarceva would enhance the efficacy of Tarceva.
Interventions
DRUGApatinib
a tyrosine kinase inhibitor of VEGF invented by Hengrui pharma in China
DRUGTarceva
DRUGPlacebo
Sponsors
First Affiliated Hospital of Kunming Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* lung adenocarcinoma proved by histology;with mutant EGFR;ECOG PS 0-2;Clinical stage IIIb or IV;without other fatal disease;without hemorrhagic disease;normal liver,renal and bone marrow function,not pregnant.
Exclusion criteria
* ECOG PS 3-5;abnormal liver,renal and bone marrow function,pregnant;with severe diseases;wild type EGFR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From date of randomization until the date of death from any cause, assessed up to 36 months | From date of randomization until the date of death from any cause, assessed up to 36 months |
| Response rate | through study completion, an average of 1 year | — |
Outcome results
None listed