A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer
NSCLC
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)
1 other identifier
interventional
111
4 countries
33
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2007
Typical duration for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
December 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedAugust 8, 2013
August 1, 2013
3.8 years
December 20, 2007
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response and Progression free survival
6 cycles, or until disease progression or unacceptable toxicity develops
Secondary Outcomes (1)
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
Study Arms (3)
A
ACTIVE COMPARATORPaclitaxel and carboplatin
B
EXPERIMENTALPaclitaxel, carboplatin and Mapatumumab 10 mg/kg
C
EXPERIMENTALPaclitaxel, carboplatin and Mapatumumab 30 mg/kg
Interventions
200 mg/m\^2 IV (in the vein), on day 1 of each 21 day cycle
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
Eligibility Criteria
You may qualify if:
- Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma
- Age 18 years or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, 35213, United States
Desert Hematology Oncology Medical Group, Inc.
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
Related Publications (1)
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.
PMID: 24560012DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
December 31, 2007
Study Start
January 1, 2007
Primary Completion
November 1, 2010
Study Completion
February 1, 2011
Last Updated
August 8, 2013
Record last verified: 2013-08