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Brief Title: CPG 7909 Injection in Non-Small Cell Lung Cancer
Official Title: Promune™ (CPG 7909 Injection) In Combination With Chemotherapy In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer, A Randomized, Multi-Center, Controlled, Phase 2 Study
Study ID: NCT00070629
Brief Summary: Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Office of Ronald Yanagihara, Gilroy, California, United States
Kenmar Research Institute, LLC, Los Angeles, California, United States
Comprehensive Cancer Center of the Dessert, Palm Springs, California, United States
Florida Cancer Specialist, Fort Myers, Florida, United States
Indiana Hematology and Oncology Associates, Indianapolis, Indiana, United States
Medical Center Vincennes, Vincennes, Indiana, United States
Kentucky Cancer Clinic, Hazard, Kentucky, United States
University of Minnesota, Minneapolis, Minnesota, United States
Southeast Nebraska Hematology Oncology Consultants, PC, Lincoln, Nebraska, United States
VA New Jersey Health Care System, East Orange, New Jersey, United States
HemOnCare, Brooklyn, New York, United States
Cancer Care of Western North Carolina, Asheville, North Carolina, United States
Providence Portland Medical Center, Portland, Oregon, United States
Cancer Care Institute of Carolina, Aiken, South Carolina, United States
Charleston Hematology/Oncology, PA, Charleston, South Carolina, United States
The Family Cancer Center, Collierville, Tennessee, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Queen Elizabeth II Health, Halifax, Nova Scotia, Canada
Ottawa Regional Cancer Center, Ottawa, Ontario, Canada
McGill University, Montreal, Quebec, Canada
Staedtisches Krankenhaus Martha-Maria, Halle-Dolau, , Germany
Universitätsklinikum Mannheim der Universität Heidelberg, Heidelberg, , Germany
St. Vincentius-Kliniken gAG, Hamatologie-Onkologie, Karlsruhe, , Germany
Klinikum Rechts der Isar, Munchen, , Germany