S0709: Erlotinib With or Without Carboplatin and Paclitaxel in Stage IIIB or Stage IV Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes:

  * Adenocarcinoma
  * Large cell carcinoma
  * Squamous cell carcinoma
  * Unspecified
* Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:

  * Selected stage IIIB disease (T4 \[secondary to malignant pleural effusion only\], any N, M0)
  * Stage IV disease (any T, any N, M1 \[distant metastases present\])
* Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan

  * The CT scan from a combined PET/CT scan may only be used to document nonmeasurable disease
  * Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
* Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
* No untreated brain metastases

  * Patients with treated brain metastases are allowed provided metastases have remained controlled for at least two weeks following treatment, AND patient has no residual neurological dysfunction off corticosteroids
  * Patients with neurologic abnormalities on physical examination or symptoms must have a negative pretreatment CT or MRI scan of the brain 28 days prior to registration

PATIENT CHARACTERISTICS:

* Zubrod performance status 2
* ANC ≥ 1,500/mm³
* Platelet count ≥ 1,000/mm³
* Serum bilirubin normal
* SGOT or SGPT normal
* Serum creatinine ≤ 2 times upper limit of normal OR creatinine clearance ≥ 50 mL/min
* Willing to provide prior smoking history as requested on the prestudy form
* No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
* No malabsorption syndrome or requirement for IV alimentation
* No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
* No significant history of cardiac disease, including any of the following:

  * Uncontrolled high blood pressure
  * Unstable angina
  * Congestive heart failure
  * Myocardial infarction within the past 6 months
  * Cardiac ventricular arrhythmia requiring medication
* No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery) and recovered
* At least 1 year since prior adjuvant chemotherapy
* No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced NSCLC
* No prior EGFR inhibitors
* No prior surgical procedures affecting absorption
* No concurrent major surgery