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

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

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

- Non-squamous histology

- Adequate renal function with calculated creatinine clearance ≥45 ml/min by Cockcroft
and Gault equation using parameters of age, weight in kilograms (kg), and baseline
serum creatinine in mg/dl.

- 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

Selection of Carboplatin versus Cisplatin: Patients may be treated with carboplatin
instead of cisplatin if they meet any one of the following criteria:

- 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 insufficiency ≤ 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.

- Patient refuses to take cisplatin