A Multicenter, Open Clinical Trial of Using TS Gene Polymorphism to Predict Effect in Patients of Advanced Lung Adenocarcinoma to Pemetrexed Combining With Cisplatin Regiment as First-line Treatment
1. Main eligibility criteria were histologic or cytologic proof of advanced non-small-cell
lung cancer (NSCLC) primary treatment, normal organ function, and Eastern Cooperative
Oncology Group performance status 0 to 2.
2. All Patients were delivered to pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 for not less
than 4 cycle, administered intravenously every 3 weeks. Response assessment was
performed every 6 weeks; toxicity assessment was performed every 3 weeks.
3. Primary end point was time to progression (TTP); secondary end points were objective
response rate (ORR), overall survival (OS), and toxicity.
4. The study was designed to evaluate TS gene polymorphism as a predictor for advanced
lung adenocarcinoma effect to pemetrexed combined with cisplatin regiment as first-line
5. Polymorphisms of thymidylate synthase were investigated in peripheral WBC of all
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
time to progress
Yi Luo, doctor
Hunan Province Tumor Hospital
China: Food and Drug Administration