OBJECTIVES:

• Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer.
• Determine the duration of response in patients treated with this regimen.
• Determine the toxicity of this treatment regimen in this patient population.
• Assess levels of circulating HER2 and correlate with HER2 expression in this patient population.

OUTLINE: Patients are stratified according to prior treatment (yes vs no).

Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks until disease progression or death.

PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IIIB or IV non-small cell lung cancer

  • Supraclavicular node involvement allowed
  • Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative)
• No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy
• Recurrent disease allowed
• HER2 overexpression (2-3+)

• At least 1 unidimensionally measurable lesion

  • At least 20 mm by conventional techniques OR
  • At least 10 mm by spiral CT scan

  • The following are not considered measurable:

    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural/pericardial effusion
    • Abdominal masses not confirmed and followed by imaging
    • Cystic lesions
• No CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• LVEF at least 45% (by echocardiogram or MUGA)

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• HIV negative
• No concurrent immunologic disease (e.g., autoimmune disease)
• No history of allergy to murine products

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior murine antibodies

Chemotherapy:

• See Disease Characteristics
• No prior anthracyclines
• No more than 1 prior chemotherapy regimen for lung cancer
• At least 4 weeks since prior chemotherapy
• No concurrent chemotherapy

Endocrine therapy:

• No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic
• No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)

Radiotherapy:

• See Disease Characteristics
• At least 6 months since prior radiotherapy
• No concurrent palliative radiotherapy

Surgery:

• At least 4 weeks since prior major surgery