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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Paclitaxel and carboplatin |
|
| B | Experimental | Paclitaxel, carboplatin and Mapatumumab 10 mg/kg |
|
| C | Experimental | Paclitaxel, carboplatin and Mapatumumab 30 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mapatumumab | Biological | 30 mg/kg IV (in the vein), on day 1 of each 21 day cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response and Progression free survival | 6 cycles, or until disease progression or unacceptable toxicity develops |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Hematology and Oncology Associates, LLC | Birmingham | Alabama | 35213 | United States | ||
| Desert Hematology Oncology Medical Group, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24560012 | Derived | von Pawel J, Harvey JH, Spigel DR, Dediu M, Reck M, Cebotaru CL, Humphreys RC, Gribbin MJ, Fox NL, Camidge DR. Phase II trial of mapatumumab, a fully human agonist monoclonal antibody to tumor necrosis factor-related apoptosis-inducing ligand receptor 1 (TRAIL-R1), in combination with paclitaxel and carboplatin in patients with advanced non-small-cell lung cancer. Clin Lung Cancer. 2014 May;15(3):188-196.e2. doi: 10.1016/j.cllc.2013.12.005. Epub 2013 Dec 27. |
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| Mapatumumab |
| Biological |
10 mg/kg IV (in the vein), on day 1 of each 21 day cycle |
|
| Paclitaxel | Drug | 200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle |
|
|
| Carboplatin | Drug | AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle |
|
|
| Rancho Mirage |
| California |
| 92270 |
| United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Osceola Cancer Center | Kissimmee | Florida | 34741 | United States |
| Palm Beach Cancer Institute | West Palm Beach | Florida | 33401 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| LaGrange Oncology Associates | LaGrange | Illinois | 60525 | United States |
| Orchard Research, LLC | Skokie | Illinois | 60076 | United States |
| Kentuckiana Cancer Institute, PLLC | Louisville | Kentucky | 40202 | United States |
| University of Maryland, Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Chevy Chase Health Care | Chevy Chase | Maryland | 20815 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Medical University of South Carolina: Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| The Sarah Cannon Cancer Center | Nashville | Tennessee | 37203 | United States |
| UT Health Science Center at San Antonio, Be Well Center | San Antonio | Texas | 78229 | United States |
| Fairfax-Northern Virginia Hematology Oncology, PC | Fairfax | Virginia | 22031 | United States |
| Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie | Berlin | 10117 | Germany |
| Universitätsmedizin Berlin, Centrum für Innere Medizin | Berlin | 10117 | Germany |
| Asklepios Fachkliniken München-Gauting | Gauting | 82131 | Germany |
| Krankenhaus Großhansdorf | Großhansdorf | 22927 | Germany |
| Krankenhaus Martha-Maria Halle-Dölau | Halle | 06120 | Germany |
| Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie | Magdeburg | 39120 | Germany |
| Klinikum der Johannes-Gutenberg-Universität Mainz | Mainz | 55131 | Germany |
| Universitätsklinikum Mannheim, Chirurgische Klinik | Mannheim | 68167 | Germany |
| Pius-Hospital | Oldenburg | 26121 | Germany |
| Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie | Osnabrück | 49076 | Germany |
| Fővárosi Önkormányzat Uzsoki Utcai Kórház | Budapest | 1145 | Hungary |
| Országos Korányi TBC és Pulmonológiai Intezet | Budapest | 1529 | Hungary |
| Debrecen University, Medical and Health Center, Dept of Oncology | Debrecen | 4032 | Hungary |
| Kenézy Gyula Kórház, Debrecen, Pulmonológia | Debrecen | 4043 | Hungary |
| Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti | Bucharest | 022328 | Romania |
| Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca | Cluj-Napoca | 400015 | Romania |
| Spitalul Clinic Judetean Oradea, Oncology Department | Oradea | 410032 | Romania |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C507357 | mapatumumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
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