Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2

You may be eligible if

• 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
• * 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
• Performance status - ECOG 0-2
• Granulocyte count at least 1,500/mm3
• Platelet count at least 100,000/mm3
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Creatinine no greater than 1.5 times ULN
• LVEF at least 45% (by echocardiogram or MUGA)
• 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
• No prior murine antibodies
• No prior anthracyclines
• No more than 1 prior chemotherapy regimen for lung cancer
• At least 4 weeks since prior chemotherapy
• No concurrent chemotherapy
• 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)
• At least 6 months since prior radiotherapy
• No concurrent palliative radiotherapy
• At least 4 weeks since prior major surgery