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