TAilored Post-Surgical Therapy in Early Stage NSCLC
Status:
Completed
Trial end date:
2016-01-21
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Intergroupe Francophone de Cancerologie Thoracique