Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)

This is an interventional treatment trial for Lung Cancer focused on measuring Carboplatin, Cisplatin, Pemetrexed (Altima), Taxotere (Docetaxel), Vinorelbine Tartrate (Navelbine), Stage IB-III, non squamous, non-small cell lung cancer, 11-106 Read More

Inclusion Criteria:

• Pathologic confirmation of NSCLC at MSKCC
• Stages IB, IIA, IIB, IIIA or IIIB NSCLC
• Primary tumor must measure ≥ 2 cm on CT imaging (per PERCIST guidelines)
• Primary tumor must be FDG-avid with an SUVmax >4.5 (to be consistent with PERCIST guidelines)
• Patients must be candidates for resection with curative intent
• Age ≥ 18 years
• Karnofsky performance status ≥ 70%
• Normal bone marrow function
• leukocytes ≥ 3,000/μl
• absolute neutrophil count ≥ 1,500/μl
• platelets ≥100,000/μl
• hemoglobin ≥9gm/dl.
• Adequate hepatic function
• Total bilirubin ≤1.5 x ULN
• AST ≤ 1.5 x UNL, ALT ≤ 1.5 x ULN
• Alkaline phosphatase ≤ 1.5x ULN
• Women of childbearing age must have a negative pregnancy test
• Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
• Patients must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients must not be receiving any other investigational agents
• History of myocardial infarction or unstable angina within the past 12 months Patients with peripheral neuropathy > grade 1
• Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection.
• Patients with diabetes mellitus requiring insulin therapy (per PERCIST guidelines)
• Patients with third space fluid which cannot be adequately controlled with drainage
• Women who are pregnant or breast-feeding
• Psychiatric illness or social situation that would limit compliance with study requirements
• Patients with known HIV infection requiring antiretroviral medications and those with AIDS
• Baseline subjective hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily living (CTCAE grade 2 or higher)
• Baseline renal function <60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).
• Congestive heart failure with New York Heart Association functional classification > II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life.

Selection of Pemetrexed versus Gemcitabine: Patients treated with pemetrexed must meet all of the following criteria:

• Non-squamous histology
• Patients must have the ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed
• Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol
• Patient refuses to take cisplatin