Customized Neoadjuvant Versus Standard Chemotherapy in NSCL Patients With Resectable Stage IIIA (N2)Disease
Summary
* The investigators hypothesized that NSCL patients receiving therapy based on their baseline tumor markers levels would attain higher response rates than patients in the control arm receiving non customized therapy. * patients with stage IIIA(N2) NSCLC will be randomized in a 2:1 ratio to customized therapy based on biomarkers status (ERCC1, RRM1, TS and EGFR mutation) vs standard chemotherapy. * The primary objective of this multicenter trial is to compare pathological complete response of all subjects randomized, by treatment arm. * Secondary objectives are to compare all randomized subjects by treatment arm for: response rate, disease-free survival, overall survival, one, two and three year survival and safety profile. The study is expected to demonstrate both the feasibility of this approach and the logistic problems associated with a biomarker-driven therapeutic strategy in NSCLC.
Timeline
- Start
- 2012-07
- Primary completion
- 2015-10
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | — | — |
| Subject | Docetaxel | Small molecule | — | — |
| Subject | Gefitinib | Small molecule | — | — |
| Subject | Gemcitabine | Small molecule | — | — |
| Subject | Pemetrexed | Small molecule | — | — |
| Subject | Vinorelbine | Small molecule | — | — |