Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of one
of the following stages:

- Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural
effusion, any N, M0)

- Newly diagnosed stage IV disease (any T, any N, M1)

- Recurrent stage IV disease after prior surgery or radiotherapy

- The following subtypes are eligible:

- Adenocarcinoma

- Squamous cell carcinoma

- Large cell carcinoma

- Unspecified

- Measurable disease by CT scan, MRI, x-ray, or physical exam

- Pleural effusions, ascites, or laboratory parameters are not acceptable as the
only evidence of disease

- Not within prior radiotherapy field unless a new lesion is present

- Not within area of prior surgical resection

- No known brain metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 9 mg/dL

Hepatic

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- SGOT or SGPT ≤ 2 times ULN

- Alkaline phosphatase ≤ 2 times ULN

- No known acute hepatitis

Renal

- Creatinine ≤ ULN

- Creatinine clearance ≥ 50 mL/min

Cardiovascular

- No significant cardiac disease

- No uncontrolled hypertension

- No unstable angina

- No congestive heart failure

Other

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated
stage I or II cancer currently in complete remission

- No active or uncontrolled infection

- No sensory neuropathy ≥ grade 2

- No known human anti-mouse antibodies

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic therapy for NSCLC

- No prior chimeric or murine monoclonal antibody therapy

- No prior cetuximab

Chemotherapy

- No prior systemic chemotherapy for NSCLC

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery

- See Disease Characteristics

- At least 2 weeks since prior thoracic or major surgery and recovered

Other

- No prior gefitinib or other investigational agents that target the epidermal growth
factor receptor pathway