CPG 7909 Injection in Non-Small Cell Lung Cancer
- Conditions
- Carcinoma, Non-Small Cell Lung
- Interventions
- Drug: CPG 7909Drug: Chemotherapy
- Registration Number
- NCT00070629
- Lead Sponsor
- Pfizer
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC).
- Patients must have measurable disease according to the RECIST criteria.
- Prior treatment with chemotherapy; patients may have received prior radiotherapy.
- Patients with suspected or known CNS metastases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 CPG 7909 Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection 1 Chemotherapy Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection 2 Chemotherapy Chemotherapy (a taxane and a platinum compound)
- Primary Outcome Measures
Name Time Method Efficacy- overall response rate (CR & PR) according to the RECIST criteria Indeterminate Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations Indeterminate
- Secondary Outcome Measures
Name Time Method Secondary Efficacy Indeterminate compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups Indeterminate duration of overall response (CR, PR), survival time, and time to disease progression. Indeterminate To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination. Indeterminate
Trial Locations
- Locations (24)
VA New Jersey Health Care System
🇺🇸East Orange, New Jersey, United States
Ottawa Regional Cancer Center
🇨🇦Ottawa, Ontario, Canada
Staedtisches Krankenhaus Martha-Maria
🇩🇪Halle-Dolau, Germany
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
The Family Cancer Center
🇺🇸Collierville, Tennessee, United States
Queen Elizabeth II Health
🇨🇦Halifax, Nova Scotia, Canada
McGill University
🇨🇦Montreal, Quebec, Canada
Klinikum Rechts der Isar
🇩🇪Munchen, Germany
Indiana Hematology and Oncology Associates
🇺🇸Indianapolis, Indiana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Office of Ronald Yanagihara
🇺🇸Gilroy, California, United States
Florida Cancer Specialist
🇺🇸Fort Myers, Florida, United States
Kenmar Research Institute, LLC
🇺🇸Los Angeles, California, United States
Southeast Nebraska Hematology Oncology Consultants, PC
🇺🇸Lincoln, Nebraska, United States
Kentucky Cancer Clinic
🇺🇸Hazard, Kentucky, United States
Cancer Care Institute of Carolina
🇺🇸Aiken, South Carolina, United States
Universitätsklinikum Mannheim der Universität Heidelberg
🇩🇪Heidelberg, Germany
St. Vincentius-Kliniken gAG, Hamatologie-Onkologie
🇩🇪Karlsruhe, Germany
Comprehensive Cancer Center of the Dessert
🇺🇸Palm Springs, California, United States
HemOnCare
🇺🇸Brooklyn, New York, United States
Medical Center Vincennes
🇺🇸Vincennes, Indiana, United States
Cancer Care of Western North Carolina
🇺🇸Asheville, North Carolina, United States
Charleston Hematology/Oncology, PA
🇺🇸Charleston, South Carolina, United States