Carboplatin, Gemcitabine, and Thalidomide in Patients Undergoing Surgery for Stage II or III Non-Small Cell Lung Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following histologic subtypes:

  • Squamous cell carcinoma
  • Adenocarcinoma
  • Large cell undifferentiated carcinoma
• Stage II or IIIA disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral Computerized Axial Tomography (CT) scan
• No tumor involving the superior sulcus (e.g., Pancoast tumor)
• Karnofsky performance status 70-100%
• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Creatinine ≤ 2 mg/dL
• Bilirubin < 2 mg/dL
• Aspartate aminotransferase (AST) < 3 times upper limit of normal

Exclusion Criteria:

• Pregnant or nursing

  • No nursing during and for ≥ 4 weeks after completion of study treatment
• Positive pregnancy test
• Fertile female patients must use 2 effective methods of contraception 4 weeks before, during, and for 4 weeks after completion of study treatment
• Fertile male patients must use effective barrier contraception during and for 4 weeks after completion of study treatment
• Blood, sperm, or ova donation during study treatment
• Post obstructive pneumonia
• Other serious infection or medical illness that would preclude study participation
• Other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other malignancy that is unlikely to affect survival for the next 3 years
• Less than 5 years since prior resection of lung disease
• Prior systemic chemotherapy or radiotherapy for non-small cell lung cancer (NSCLC)
• Other concurrent chemotherapy or radiotherapy
• Concurrent hormonal therapy or immunotherapy
• Other concurrent anticancer therapy
• Other concurrent investigational agents
• Concurrent participation in another clinical study