Non Small Cell Lung CancerPhase 2NSCLCNCT00583830
A Study of Mapatumumab in Combination With Paclitaxel and Carboplatin in Subjects With Non-small Cell Lung Cancer
A Phase 2 study testing Mapatumumab, Paclitaxel and Carboplatin in people with Non Small Cell Lung Cancer, run by Human Genome Sciences Inc. at 33 sites in 4 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Mapatumumab, Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 33 sitesin 4 countries
- Study dates
- Jan 2007to Feb 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma
- Age 18 years or older
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
33 sites in 4 countries.
33 sites in 4 countries
United States16 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80045
University of Maryland, Greenebaum Cancer Center
Baltimore, Maryland, 21201
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, 35213
Medical University of South Carolina: Hollings Cancer Center
Charleston, South Carolina, 29425
Chevy Chase Health Care
Chevy Chase, Maryland, 20815
Rush University Medical Center
Chicago, Illinois, 60612
Fairfax-Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, 22031
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Osceola Cancer Center
Kissimmee, Florida, 34741
LaGrange Oncology Associates
LaGrange, Illinois, 60525
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, 40202
The Sarah Cannon Cancer Center
Nashville, Tennessee, 37203
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, 92270
UT Health Science Center at San Antonio, Be Well Center
San Antonio, Texas, 78229
Orchard Research, LLC
Skokie, Illinois, 60076
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401
Germany10 sites
Charite - Campus Mitte, Universitätsmedizin Berlin, Abteilung Onkologie und Hämatologie
Berlin, 10117
Universitätsmedizin Berlin, Centrum für Innere Medizin
Berlin, 10117
Asklepios Fachkliniken München-Gauting
Gauting, 82131
Krankenhaus Großhansdorf
Großhansdorf, 22927
Krankenhaus Martha-Maria Halle-Dölau
Halle, 06120
Universitätsklinik Magdeburg, Klinik für Kardiologie, Angiologie und Pneumologie
Magdeburg, 39120
Klinikum der Johannes-Gutenberg-Universität Mainz
Mainz, 55131
Universitätsklinikum Mannheim, Chirurgische Klinik
Mannheim, 68167
Pius-Hospital
Oldenburg, 26121
Paracelsus Klinik, Zentrum für Tumordiagnostik und -therapie
Osnabrück, 49076
Hungary4 sites
Fővárosi Önkormányzat Uzsoki Utcai Kórház
Budapest, 1145
Országos Korányi TBC és Pulmonológiai Intezet
Budapest, 1529
Debrecen University, Medical and Health Center, Dept of Oncology
Debrecen, 4032
Kenézy Gyula Kórház, Debrecen, Pulmonológia
Debrecen, 4043
Romania3 sites
Institutul Oncologic 'Prof Dr. Al Trestioreanu' Bucuresti
Bucharest, 022328
Institutul Oncologic 'Prof . Dr. I. Chiricuta' Cluj-Napoca
Cluj-Napoca, 400015
Spitalul Clinic Judetean Oradea, Oncology Department
Oradea, 410032
About this study
Official 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).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Mapatumumab, Paclitaxel, Carboplatin
- Keywords
- Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MapatumumabBiological
30 mg/kg IV (in the vein), on day 1 of each 21 day cycle
MapatumumabBiological
10 mg/kg IV (in the vein), on day 1 of each 21 day cycle
PaclitaxelDrug
Also called Tax01, Paxene
200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle
CarboplatinDrug
Also called Paraplatin
AUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Paclitaxel and carboplatin Receives: Drug: Paclitaxel; Drug: Carboplatin |
| B | Experimental | Paclitaxel, carboplatin and Mapatumumab 10 mg/kg Receives: Biological: Mapatumumab; Drug: Paclitaxel; Drug: Carboplatin |
| C | Experimental | Paclitaxel, carboplatin and Mapatumumab 30 mg/kg Receives: Biological: Mapatumumab; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response and Progression free survival
Measured: 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.
Measured: 6 cycles, or until disease progression or unacceptable toxicity develops
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Human Genome Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583830
- Sponsor's protocol ID
- HGS1012-C1072
- Acronym
- NSCLC
- Status last verified
- Aug 2013
- First submitted
- 20 Dec 2007
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24560012
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT00583830
- Acronym / sponsor ID
- NSCLC / HGS1012-C1072
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Human Genome Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 31 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Paclitaxel, Drug: CarboplatinPaclitaxel and carboplatin |
| B | Experimental | Biological: Mapatumumab, Drug: Paclitaxel, Drug: CarboplatinPaclitaxel, carboplatin and Mapatumumab 10 mg/kg |
| C | Experimental | Biological: Mapatumumab, Drug: Paclitaxel, Drug: CarboplatinPaclitaxel, carboplatin and Mapatumumab 30 mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with histologically or cytologically confirmed stage IIIB or stage IV advanced primary non-small cell lung cancinoma
- Age 18 years or older
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mapatumumab30 mg/kg IV (in the vein), on day 1 of each 21 day cycle | Biological | C |
| Mapatumumab10 mg/kg IV (in the vein), on day 1 of each 21 day cycle | Biological | B |
| PaclitaxelAlso: Tax01, Paxene200 mg/m^2 IV (in the vein), on day 1 of each 21 day cycle | Drug | A, B, C |
| CarboplatinAlso: ParaplatinAUC 6.0 mg min/ml IV (in the vein), on day 1 of each 21 day cycle | Drug | A, B, C |
Primary outcome
Objective response and Progression free survival
Time frame: 6 cycles, or until disease progression or unacceptable toxicity develops
1 secondary outcome
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.
Time frame: 6 cycles, or until disease progression or unacceptable toxicity develops
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
- Derived from this study: PubMed 24560012von 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
33 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mapatumumab, Paclitaxel and Carboplatin in people with Non Small Cell Lung Cancer, run by Human Genome Sciences Inc. at 33 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Germany, Hungary, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response and Progression free survival (time frame: 6 cycles, or until disease progression or unacceptable toxicity develops). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00583830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2013.