Non Small Cell Lung Cancer Clinical Trial
— NSCLCOfficial title:
A Phase 2, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Mapatumumab in Combination With Carboplatin and Paclitaxel as First Line Therapy in Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC)
The purpose of this study is to evaluate the efficacy (disease response) and safety of mapatumumab in combination with carboplatin and paclitaxel as first line therapy in subjects with advanced non-small cell lung cancer (NSCLC).
Status | Completed |
Enrollment | 111 |
Est. completion date | February 2011 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma - Age 18 years or older Exclusion Criteria: - Received investigational (not yet approved by a regulatory authority) or non-investigational agent to treat Lung Cancer - Received radiation therapy within 4 weeks before randomization - Major surgery within 4 weeks before randomization - Minor surgery within 2 weeks before randomizaiton - Systemic steroids within 1 week before randomization - Any grade 2 or greater neuropathy - History of severe (Grade 4) hypersensitivity reaction to products containing Cremophor EL (cyclosporine, teniposide) - History of any infection requiring hospitalization or antibiotics within 2 weeks before randomization - Known brain or spinal cord metastases - History of other cancers within 5 years before randomization - Known HIV, hepatitis-B or hepatitis-C infection - Pregnant or breast-feeding women - Previously treated with Mapatumumab |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie | Berlin | |
Germany | Universitätsmedizin Berlin, Centrum für Innere Medizin | Berlin | |
Germany | Asklepios Fachkliniken München-Gauting | Gauting | |
Germany | Krankenhaus Großhansdorf | Großhansdorf | |
Germany | Krankenhaus Martha-Maria Halle-Dölau | Halle | |
Germany | Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie | Magdeburg | |
Germany | Klinikum der Johannes-Gutenberg-Universität Mainz | Mainz | |
Germany | Universitätsklinikum Mannheim, Chirurgische Klinik | Mannheim | |
Germany | Pius-Hospital | Oldenburg | |
Germany | Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie | Osnabrück | |
Hungary | Fovárosi Önkormányzat Uzsoki Utcai Kórház | Budapest | |
Hungary | Országos Korányi TBC és Pulmonológiai Intezet | Budapest | |
Hungary | Debrecen University, Medical and Health Center, Dept of Oncology | Debrecen | |
Hungary | Kenézy Gyula Kórház, Debrecen, Pulmonológia | Debrecen | |
Romania | Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti | Bucuresti | |
Romania | Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca | Cluj-Napoca | |
Romania | Spitalul Clinic Judetean Oradea, Oncology Department | Oradea | |
United States | University of Colorado Health Sciences Center | Aurora | Colorado |
United States | University of Maryland, Greenebaum Cancer Center | Baltimore | Maryland |
United States | Birmingham Hematology and Oncology Associates, LLC | Birmingham | Alabama |
United States | Medical University of South Carolina: Hollings Cancer Center | Charleston | South Carolina |
United States | Chevy Chase Health Care | Chevy Chase | Maryland |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Fairfax-Northern Virginia Hematology Oncology, PC | Fairfax | Virginia |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
United States | Osceola Cancer Center | Kissimmee | Florida |
United States | LaGrange Oncology Associates | LaGrange | Illinois |
United States | Kentuckiana Cancer Institute, PLLC | Louisville | Kentucky |
United States | The Sarah Cannon Cancer Center | Nashville | Tennessee |
United States | Desert Hematology Oncology Medical Group, Inc. | Rancho Mirage | California |
United States | UT Health Science Center at San Antonio, Be Well Center | San Antonio | Texas |
United States | Orchard Research, LLC | Skokie | Illinois |
United States | Palm Beach Cancer Institute | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Human Genome Sciences Inc. |
United States, Germany, Hungary, Romania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response and Progression free survival | 6 cycles, or until disease progression or unacceptable toxicity develops | No | |
Secondary | Disease control; Overall survival; Response duration and time to response in responders; Frequency and severity of treatment-emergent adverse events; Laboratory parameters; and Serum mapatumumab concentrations for use in a PK analysis. | 6 cycles, or until disease progression or unacceptable toxicity develops | Yes |
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