A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781; IND# 63,383) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers

Inclusion Criteria:

- Renal: Creatinine =< 1.5 mg/dL

- Histologically confirmed primary non-small cell lung cancer (NSCLC)

- Adenocarcinoma histology, including any of the following histologic variants: pure or
mixed bronchoalveolar cell carcinoma, adenosquamous cell carcinoma

- No NSCLC not otherwise specified

- Pathology block or unstained slides from initial or subsequent diagnosis available

- At least a core biopsy required

- Fine needle aspirate alone is not sufficient

- Meets 1 of the following stage criteria: s

- elect stage IIIB disease with cytologically documented malignant pleural or

- pericardial effusion or stage IV disease

- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by
conventional techniques OR >= 10 mm by spiral CT scan

- The following are considered non-measurable disease:

- bone lesions,

- leptomeningeal disease;

- ascites;

- pleural or pericardial effusion;

- lymphangitis cutis/pulmonis;

- abdominal masses not confirmed and followed by imaging techniques;

- cystic lesions

- Meets 1 of the following criteria for smoking history:

- non-smoker,

- defined as a person who smoked =< 100 cigarettes in their lifetime;

- former light smoker,

- defined as a person who smoked =< 10 pack years AND

- quit smoking >= 1 year ago

- No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically
unstable, symptomatic, and/or requires corticosteroids)

- ECOG 0-1

- Hematopoietic:

- Granulocyte count >= 1,500/mm^3;

- Platelet count >= 100,000/mm^3;

- Hemoglobin >= 9.0 g/dL

- Hepatic:

- AST =< 2.5 times upper limit of normal (ULN);

- Total bilirubin =< ULN

- Gastrointestinal:

- Able to swallow tablets intact or dissolved in water;

- no dysphagia;

- no active gastrointestinal disease or disorder that would alter gastrointestinal
motility or absorption;

- no lack of integrity of the gastrointestinal tract

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No prior trastuzumab (Herceptin) or cetuximab

- No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy

- No other concurrent chemotherapy

- No concurrent hormonal therapy except for the following:

- hormones for non-disease-related conditions (e.g., insulin for diabetes);

- steroids for adrenal failure;

- intermittent use of dexamethasone as an antiemetic or to prevent paclitaxel
hypersensitivity reactions

- At least 3 weeks since prior radiotherapy, including cranial irradiation

- No concurrent radiotherapy, including palliative radiotherapy

- At least 3 weeks since prior major surgery

- No prior significant surgical resection of the stomach or small bowel

- No prior erlotinib, gefitinib, or lapatinib

- No other prior treatment targeting the HER family axis

- More than 4 weeks since prior and no other concurrent investigational agents