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TAilored Post-Surgical Therapy in Early Stage NSCLC — TASTE  

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:
Randomized Phase II/III Adjuvant Trial Evaluating Feasibility of Standard (A) vs. Customized Treatment (B) in Stage II or Stage IIIA Non-N2, Non-squamous Non Small Cell Lung Cancer (NSCLC).

Clinical Trial Summary

Our hypothesis is that patients receiving therapy based on their baseline tumor ERCC1 levels and EGFR mutations would attain better disease free survival rates than patients in the control arm receiving noncustomized therapy. Using this selective approach, patients with stage II and IIIA non N2 NSCLC in the genotypic arm with low ERCC1 levels will receive cisplatin plus pemetrexed, and those with high ERCC1 levels will not receive cisplatin-based chemotherapy. If they harbor EGRF mutations they will be treated with erlotinib.

The study will be restricted to non-squamous NSCLC for two mains reasons. First, this will enrich the EGFR mutation rate that is awaited to be higher in these tumors than in squamous cell carcinoma. Second, permetrexed cisplatin combination has a promising efficacy and favorable toxicity profile and is of potential interest in the adjuvant setting of resected non-squamous NSCLC.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00775385
Study type Interventional
Source Intergroupe Francophone de Cancerologie Thoracique
Contact
Status Completed
Phase Phase 2/Phase 3
Start date April 2009
Completion date January 21, 2016
View Details
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