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

Completed · Phase 2

Conditions studied: Lung Cancer

In brief

The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer. It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery. In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.

Key facts

Study ID: NCT01443078
Run by: Memorial Sloan Kettering Cancer Center
People needed: 42
Starts: 2011-10-01
Expected to finish: 2015-04-01
Last updated by the study team: 2018-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

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

Full record on ClinicalTrials.gov

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