A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas

Histologically or cytologically confirmed, incompletely resected or unresectable adenocarcinoma NSCLC. No squamous ca in any histologic or cytologic sample. Pts must be a lifelong non-smoker (<100 cigarettes lifetime) and willing to provide smoking history. Pts must have selected St IIIB or St IV disease. Tumors may be multi focal or diffuse (see Sec. 5.3). Pts must have measurable and/or non-measurable disease documented by chest CT (recommended) or CT/PET and/or MRI. PET/CT may only be used for non-measurable disease. If PET/CT is used for any disease assessment, designate all lesions as non-target. Measurable disease must be assessed w/i 28days. Pleural effusions, ascites and lab parameters are not acceptable as only evidence of disease. Non-measurable disease must be assessed w/i 42 days. No symptomatic brain mets. Pts may have rec�d prior RT completed at least 28 days prior to registration or palliative RT completed at lease 14 days prior to registration. Measurable or non-measurable disease must be present outside the previous radiation field or a new lesion inside the port must be present. Prior sx completed at least 28 days prior to registration is allowed. Pts must not have had a fine needle or core bx w/i 7 days. Pts may have rec�d systemic chemo (d/c w/i 28 days) or bio therapy. No prior tx with ZD1839, OSI-774, bevacizumab, or other EGFR or VEGF targeted tx. Pts must not have had hemoptysis >/= � tsp w/i 28 days. Pts must not have had clinical history of pulmonary/upper resp hemorrhage >/= Grade 2 w/i 6 months of Grade 1 w/i 28 days; no history of thrombosis or hemorrhage. Pts must have adequate hepatic function: bili </= 1 x IULN and SGOT or SGPT </= 2.5 x IULN. If liver mets are present, SGOT/SGPT </= 5x IULN. Adequate renal function: serum creat </= 1.5 x IULN or calc or measured creat clearance >/= 50 using formula in Sec 5.13. For UPC ratio >0.5, 24-hour urine protein must be obtained w/i 28 days and the level <1000 (use formula in Sec.5.14). .ANC >/= 1,5000, platelet >/= 100,000. Controlled hypertension allowed. Pts must have PS 0-2, 18 years or older. Pts strongly encouraged to submit specimens as outlined in Sec. 15.0. Pts must not be receiving or planning to receive sx or other non-protocol tx (including chemo, hormone, bio, or RT) directed at the NSCLC. Pts must not have serious non-healing wound, ulcer, or bone fx. No other prior malignancy except: treated basal cell or squamous cell skin ca, in situ cervical, Stage I or II ca in complete remission; disease-free from any ca for 5 years. No pregnant or nursing women.