Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
Eli Lilly and Company
United States Department of Defense
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN)
