A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer

Study start date: February 1, 2000

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