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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)

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

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


- 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

- 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

- 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

- Patients with known HIV infection requiring antiretroviral medications and those with

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate by FDG PET

Outcome Description:

(complete metabolic response + partial metabolic response) to alternative, non-platinum chemotherapy (vinorelbine + docetaxel) in patients with resectable Stage Ib-IIIa, NSCLC who do not respond to 2 cycles of platinum-based chemotherapy. The baseline for comparison for the primary endpoint is the PET scan performed immediately before the alternative chemotherapy.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jamie E. Chaft, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2011

Completion Date:

September 2014

Related Keywords:

  • Lung Cancer
  • Carboplatin
  • Cisplatin
  • Pemetrexed (Altima)
  • Taxotere (Docetaxel)
  • Vinorelbine Tartrate (Navelbine)
  • Stage IB-III
  • non squamous
  • non-small cell lung cancer
  • 11-106
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center Sleepy Hollow, New York  10591
Memoral Sloan Kettering Cancer Center Basking Ridge, New Jersey  
Memorial Sloan-Kettering Cancer Center @ Suffolk Commack, New York  11725
Memorial Sloan-Kettering at Mercy Medical Center Rockville Centre, New York