Safety Study of Cetuximab in Combination With Cisplatin and Vinorelbine to Treat Advanced Non-small Cell Lung Cancer

Completed · Phase 2

Conditions studied: Lung Neoplasms, Carcinoma, Cancer of the Lung, Non-Small-Cell Lung Carcinoma

In brief

The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.

Key facts

Study ID

NCT01109524

Run by

Eli Lilly and Company

People needed

72

Starts

2010-07-01

Expected to finish

2012-09-01

Last updated by the study team

2015-12-24

Who can join

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

You may qualify if…

• Non-Small Cell Lung Cancer (NSCLC), Stage IV (per the American Joint Committee on Cancer (AJCC) Staging Manual, Seventh Edition) or recurrent disease following surgery and/or radiation therapy
• Evaluable or measurable disease
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

You may not qualify if…

• Uncontrolled Central Nervous System (CNS) metastasis.
• Previous exposure to monoclonal antibodies, signal transduction inhibitors or Epidermal growth factor receptor (EGFR) targeting therapy
• Concurrent malignancy
• Prior chemotherapy for NSCLC
• Pre-existing ascites grade ≥ 2 or pericardial effusion grade ≥ 2
• Superior vena cava syndrome contra-indicating hydration
• White Blood Cells (WBC) < 3,000/mm³
• Absolute neutrophile count (ANC) < 1,500/mm³
• Platelet < 100,000/mm³
• Hemoglobin (Hgb) < 9.0 g/dL
• Total bilirubin > 1.5 x Upper limit of normal (ULN).
• Aspartate aminotransferase (AST) or Alanine-aminotransferase (ALT) > 5.0 x ULN.
• Serum creatinine >1.25 x ULN and calculated creatinine clearance <60mL/min

Where it is running

• Donald W. Hill M.D., P.C. — Casa Grande, Arizona, United States
• Beverly Hills Cancer Center — Beverly Hills, California, United States
• Cancer Care Institute — Los Angeles, California, United States
• Northern California Hematology & Oncology — Oakland, California, United States
• Sharp Clinical Oncology Research — San Diego, California, United States
• Broward Oncology Associates, P.A. — Fort Lauderdale, Florida, United States
• Elite Research Institute — Miami, Florida, United States
• Edward H. Kaplan, MD & Associates — Skokie, Illinois, United States
• Fairview Southdale Medical Oncology Clinic — Edina, Minnesota, United States
• Mid Dakota Clinic, Pc — Bismarck, North Dakota, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• University Medical Center — Lubbock, Texas, United States
• Columbia Basin Hematology and Oncology — Kennewick, Washington, United States
• The Moncton Hospital — Moncton, New Brunswick, Canada
• Local Institution — Grand Falls-Windsor, Newfoundland and Labrador, Canada
• Sudbury Regional Hospital — Greater Sudbury, Ontario, Canada
• The Credit Valley Hospital — Mississauga, Ontario, Canada
• Thunder Bay Regional Health Sciences Centre (Regional Cancer Care) — Thunder Bay, Ontario, Canada
• Toronto East General Hospital — Toronto, Ontario, Canada
• Centre de sante et de services sociaux de Rimouski-Neigette — Rimouski, Quebec, Canada
• Ponce School of Medicine (Caimed Center) — Ponce, Puerto Rico
• Fundacion de Investigacion de Diego — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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