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

Inclusion Criteria

• •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