Lung Cancer Clinical Trial

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

Summary

A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given in combination with carboplatin and pemetrexed compared to placebo. The administration of carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small cell lung cancer.

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Full Description

Patients will be enrolled at centers in North America, Western Europe, Australia and New Zealand. Up to 28 days (4 weeks) prior to treatment.

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.

View Eligibility Criteria

Eligibility Criteria

Main Inclusion Criteria:

Signed Informed Consent Form
Histologically or cytologically confirmed Stage IV non-squamous NSCLC
Availability of FFPE (formalin-fixed paraffin-embedded) tumor tissue, either fresh core-needle-biopsied or archived
Age > or = to 21 years
ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1
Disease that is measurable per RECIST v1.1
Adequate organ and marrow function
For women of childbearing potential, agreement to use two effective forms of contraception

Main Exclusion Criteria:

Histologically or cytologically documented, advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas
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])
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
Evidence of tumor invading major blood vessels, cavitation of one or more pulmonary tumor mass(es) or tracheo-esophageal fistula
Brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
Malignancies other than non-squamous NSCLC successfully treated within 3 years prior to randomization (with the exception of certain early-stage cancers)
History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
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
Recent hemoptysis >2.5 mL or serious bleeding from another site, known bleeding disorder or coagulopathy or therapeutic anti-coagulation
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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT02259582

Recruitment Status:

Completed

Sponsor:

OncoMed Pharmaceuticals, Inc.

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There are 44 Locations for this study

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Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage California, 92270, United States
University of California, San Francisco
San Francisco California, . 941, United States
Smilow Cancer Hospital at Yale-New Haven
New Haven Connecticut, 06510, United States
Ocala Oncology Center
Ocala Florida, 34471, United States
Edward H. Kaplan MD & Associates
Skokie Illinois, 60076, United States
Anne Arundel Medical Center
Annapolis Maryland, 21401, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Karmanos Cancer Institute
Detroit Michigan, 4820I, United States
Broome Oncology, LLC
Binghamton New York, 13905, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Hematology Oncology Associates of Rockland
Nyack New York, 10960, United States
Gaston Hematology & Oncology
Gastonia North Carolina, 28054, United States
Gabrail Cancer Center Research
Canton Ohio, 44718, United States
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
University of Texas Medical Branch at Galveston
Galveston Texas, 77555, United States
Texas Oncology-Sherman
Sherman Texas, 75090, United States
Compass Oncology
Vancouver Washington, 98684, United States
Chris O'Brien Lifehouse
Camperdown New South Wales, 2050, Australia
The Kinghorn Cancer Centre
Darlinghurst New South Wales, 2010, Australia
North Coast Cancer Institute Port Macquarie Base Hospital
Port Macquarie New South Wales, 2444, Australia
Royall Brisbane & Women's Hospital
Herston Queensland, 4029, Australia
Icon Cancer Foundation
Milton Queensland, 4064, Australia
The Queen Elizabeth Hospital
Woodville South South Australia, 5011, Australia
Monash Health, Monash Cancer Centre-Moorabbin
Bentleigh East Victoria, 3165, Australia
St. John of God Subiaco Hospital
Subiaco Western Australia, 6008, Australia
Ziekenhuisnetwerk Antwerpen- Koningin Paola Kinderzickenhuis
Antwerpen , 2020, Belgium
Grand Hopital de Charleroi- Site Notre-Dame
Charleroi , 6000, Belgium
Centre Hospitalier Jolimont-Lobbes
La Louviere , 7100, Belgium
CHR de Ia Citadelle
Liege , 4000, Belgium
Azienda Ospedaliera Istituti Ospitalieri
Cremona Lombardia, 26100, Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino Piemonte, 10126, Italy
Smilow Cancer Hospital at Yale-New Haven
Aviano Pordenone, 33081, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa Toscana, 56126, Italy
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Hospital Puerta de Hierro Majadahonda
Majadahonda Madrid, 28222, Spain
Hospital Nuestra Senora de Sonsoles
Avila , 05004, Spain
Hospital Universitari Vall D'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Institute Catalan de Oncologia (ICO L'Hospitalet)
Barcelona , 08908, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital General Universitario Gregorio Marañon
Madrid , 28009, Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Madrid Universitario Sanchinarro
Madrid , 28050, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT02259582

Recruitment Status:

Completed

Sponsor:


OncoMed Pharmaceuticals, Inc.

How clear is this clinincal trial information?

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