19130 Background: B improves survival in first-line treatment of selected patients (pts) with NSCLC. The addition of an EGFR inhibitor to B appears promising. Methods: Eligible pts with untreated stage IIIB (pleural effusion) or IV NSCLC and good PS were enrolled. Pts with brain metastasis, squamous histology, or hemoptysis were excluded. Treatment consisted of 3 modules. Module A: up to 4 cycles of B (15 mg/kg) every 21 days and E (150 mg qd). Module B: up to 4 cycles of carboplatin (AUC=6), paclitaxel (200 mg/m2) and B (15 mg/kg) every 21 days. Pts who had SD or any response in module A then continued treatment in module C: B every 21 days and E until PD. This study follows a three- stage design, with a maximum sample of 48 pts. The primary objective was to determine the rate of non-PD after module A. Results: 48 pts have been enrolled. Demographics: 30 males (62%), with a median age of 65 years (35–80). 79.2% (n=38) were Caucasian. ECOG PS was 1 in 60% (n=29). 45 (94%) pts had stage IV disease. 66% (n=32) of pts’ tumors were adenocarcinomas, followed by NSCLC not otherwise specified in 25% (n=12). 70% of pts were heavy smokers. In module A, 63% of pts had 4 cycles (n=30). Lack of progression was seen in 64% (n=31), and 12% had a PR. Treatment-related (TR) grade 3/4 AEs: 12% of pts had rash, 6% neuropathy, 4% diarrhea, 4% bowel perforation. 37 pts were treated on module B, with 36 evaluable for response (1 was taken off study due to thrombosis), resulting in PR in 21% (n=8), SD in 45% (n=17) and PD in 29% (n=11). TR grade 3/4 AEs: 10% of pts had neutropenia, 10% neuropathy, 8% infection. 23 pts were treated on module C (median 7 cycles per pt). 19 pts were evaluated for response: 17% (n=4) had PR, 39% (n=9) had SD and 26% (n=6) had PD. TR grade 3/4 AEs: 10% had thrombosis, 10% diarrhea, 10% neuropathy, one patient each with vomiting, anorexia, weight loss and one required an aneurysmal repair. 10 pts remain on study. Median survival for all pts was 12.9 months (95% CI= 7.1 to 18.6 mo). 1-year survival rate was 49%. Pts who had SD or PR in module A had a median survival of 23.2 mo (versus 6.6 mo, p<0.001). Conclusions: The combination of B and E followed by chemotherapy is feasible in pts with advanced NSCLC. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Genentech