Biomarker analysis from TRUST, a trial of erlotinib in non-small cell lung cancer (NSCLC)

7674 Background: The EGFR tyrosine kinase inhibitor erlotinib significantly prolonged survival and improved QoL in relapsed NSCLC patients (pts) (Shepherd et al. NEJM 2005;353:123). TRUST is an ongoing, single arm, international, multicenter trial providing erlotinib access to pts with advanced NSCLC (>6,500 enrolled). Methods: Stage IIIb/IV NSCLC; failed (1–2 regimens) or unsuitable for chemotherapy. Pts received erlotinib 150 mg/day p.o. until progression or unacceptable toxicity. Pts were assessed for response, progression free survival (PFS), overall survival (OS) and safety. Where possible, tumor tissue samples were collected from German centers and centrally assessed by; immunohistochemistry (IHC; EGFR, pMAPK), fluorescence in-situ hybridization (FISH; EGFR gene copy number), and DNA sequencing (EGFR, KRAS gene mutations). Results were assessed for correlations with treatment benefit. Results: Nov 2006, biomarker data were available for 287 of 393 German pts; median age 65 yrs (range 33–90). Baselin...