A Phase II Study of the mTOR Inhibitor, CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer

Study start date: February 1, 2004

Inclusion Criteria: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB (with pleural effusion) or IV disease * Measurable disease * At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan * The following are not considered measurable disease: * Bone lesions * Leptomeningeal disease * Ascites * Pleural/pericardial effusion * Inflammatory breast disease * Lymphangitis cutis/pulmonis * Cystic lesions * Abdominal masses that are not confirmed and followed by imaging techniques * Blood and tissue blocks available * Must have accessible tumor (i.e., superficial lesions such as lymph node, subcutaneous nodules) to provide core needle biopsy tissue before and during study treatment * No known brain metastases * Performance status - ECOG 0-2 * At least 12 weeks * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL * Bilirubin ≤ 2 times upper limit of normal (ULN) * AST ≤ 3 times ULN (5 times ULN if hepatic metastases are present) * Creatinine ≤ 1.5 times ULN * Serum fasting cholesterol ≤ 350 mg/dL * Serum fasting triglycerides ≤ 400 mg/dL * HIV negative * No uncontrolled infection * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or non-invasive carcinomas * No concurrent severe underlying disease that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study treatment * No prior biologic therapy * No prior gene therapy * No prior immunotherapy * No concurrent immunotherapy * No concurrent prophylactic growth factors to support neutrophil count * No prior chemotherapy for NSCLC except low-dose cisplatin as a radiosensitizer * No other concurrent chemotherapy * No concurrent dexamethasone (10 mg IV) * No prior radiotherapy to 30% or more of bone marrow * Concurrent radiotherapy for underlying malignancy and non-target sites (e.g., painful pre-existing bony metastasis) allowed * No other concurrent investigational therapy * No concurrent immunosuppressive therapy