A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer
NCT ID: NCT02259582
Last Updated: 2020-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
82 participants
INTERVENTIONAL
2015-02-28
2017-04-07
Brief Summary
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Detailed Description
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If enrolled in the study, you will receive intravenous (in the vein) infusions of demcizumab (or placebo), carboplatin, and pemetrexed administered on the same day, every 21 days for 4 cycles, or until it has been shown that your cancer has gotten worse. If your physician decides to delay treatment with one of the agents due to side effects, the other agents may still be administered as scheduled. After 4 cycles, if you have stable or improved disease, you will continue to receive pemetrexed once every 21 days as maintenance therapy. After 8 cycles, if you have stable or improved disease, you may receive demcizumab (or placebo), every 21 days for 4 more cycles.
You will undergo assessments every 6 weeks to determine the status of your disease.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1 Pem, carbo, placebo x 4 cycles
Pemetrexed (500 mg/m2),carboplatin (area under the concentration-time curve of 6 mg/mL x min) once every 21 days X 4 cycles, pemetrexed maintenance and placebo starting at Day 84
Pemetrexed
Carboplatin
Arm 2 Pem, carbo x 4 cycles, one course of dem
Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, one course of demcizumab 5mg/kg, maintenance pemetrexed + placebo starting on Day 84
Pemetrexed
Carboplatin
demcizumab
Arm 3 pem, carbo, dem x 4 cycles, dem retreatment
Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, maintenance pemetrexed starting on Day 84. 2 courses of demcizumab 5 mg/kg
Pemetrexed
Carboplatin
demcizumab
Interventions
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Pemetrexed
Carboplatin
demcizumab
Eligibility Criteria
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Inclusion Criteria
2. Histologically or cytologically confirmed Stage IV non-squamous NSCLC
3. Availability of FFPE (formalin-fixed paraffin-embedded) tumor tissue, either fresh core-needle-biopsied or archived
4. Age \> or = to 21 years
5. ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
6. Disease that is measurable per RECIST v1.1
7. Adequate organ and marrow function
8. For women of childbearing potential, agreement to use two effective forms of contraception
Exclusion Criteria
2. NSCLC with known EGFR (epidermal growth factor receptor ) mutation or anaplastic lymphoma kinase (ALK) gene translocation (such as EML4 \[echinoderm microtubule-associated protein-like 4\]-ALK \[anaplastic lymphoma kinase\])
3. Prior or ongoing therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy) for the treatment of Stage IV non-squamous NSCLC
4. Evidence of tumor invading major blood vessels, cavitation of one or more pulmonary tumor mass(es) or tracheo-esophageal fistula
5. Brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
6. Malignancies other than non-squamous NSCLC successfully treated within 3 years prior to randomization (with the exception of certain early-stage cancers)
7. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
8. Significant intercurrent illness defined as an illness that may result in the subject's death prior to their death from non-squamous NSCLC and/or significantly limit their ability to comply with the requirements of this study
9. Recent hemoptysis \>2.5 mL or serious bleeding from another site, known bleeding disorder or coagulopathy or therapeutic anti-coagulation
10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure during the course of the study
21 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
OncoMed Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States
University of California, San Francisco
San Francisco, California, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States
Ocala Oncology Center
Ocala, Florida, United States
Edward H. Kaplan MD & Associates
Skokie, Illinois, United States
Anne Arundel Medical Center
Annapolis, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Broome Oncology, LLC
Binghamton, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Hematology Oncology Associates of Rockland
Nyack, New York, United States
Gaston Hematology & Oncology
Gastonia, North Carolina, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, United States
Texas Oncology-Sherman
Sherman, Texas, United States
Compass Oncology
Vancouver, Washington, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
The Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia
North Coast Cancer Institute Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Royall Brisbane & Women's Hospital
Herston, Queensland, Australia
Icon Cancer Foundation
Milton, Queensland, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Monash Health, Monash Cancer Centre-Moorabbin
Bentleigh East, Victoria, Australia
St. John of God Subiaco Hospital
Subiaco, Western Australia, Australia
Ziekenhuisnetwerk Antwerpen- Koningin Paola Kinderzickenhuis
Antwerp, , Belgium
Grand Hopital de Charleroi- Site Notre-Dame
Charleroi, , Belgium
Centre Hospitalier Jolimont-Lobbes
La Louvière, , Belgium
CHR de Ia Citadelle
Liège, , Belgium
Azienda Ospedaliera Istituti Ospitalieri
Cremona, Lombardy, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
Smilow Cancer Hospital at Yale-New Haven
Aviano, Pordenone, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Nuestra Senora de Sonsoles
Ávila, , Spain
Hospital Universitari Vall D'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Institute Catalan de Oncologia (ICO L'Hospitalet)
Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Madrid Universitario Sanchinarro
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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M18-007
Identifier Type: -
Identifier Source: org_study_id
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