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.
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.
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
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There are 44 Locations for this study
Rancho Mirage California, 92270, United States
San Francisco California, . 941, United States
New Haven Connecticut, 06510, United States
Ocala Florida, 34471, United States
Skokie Illinois, 60076, United States
Annapolis Maryland, 21401, United States
Detroit Michigan, 48202, United States
Detroit Michigan, 4820I, United States
Binghamton New York, 13905, United States
Buffalo New York, 14263, United States
Nyack New York, 10960, United States
Gastonia North Carolina, 28054, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44106, United States
Dallas Texas, 75246, United States
Galveston Texas, 77555, United States
Sherman Texas, 75090, United States
Vancouver Washington, 98684, United States
Camperdown New South Wales, 2050, Australia
Darlinghurst New South Wales, 2010, Australia
Port Macquarie New South Wales, 2444, Australia
Herston Queensland, 4029, Australia
Milton Queensland, 4064, Australia
Woodville South South Australia, 5011, Australia
Bentleigh East Victoria, 3165, Australia
Subiaco Western Australia, 6008, Australia
Antwerpen , 2020, Belgium
Charleroi , 6000, Belgium
La Louviere , 7100, Belgium
Liege , 4000, Belgium
Cremona Lombardia, 26100, Italy
Torino Piemonte, 10126, Italy
Aviano Pordenone, 33081, Italy
Pisa Toscana, 56126, Italy
Badalona Barcelona, 08916, Spain
Majadahonda Madrid, 28222, Spain
Avila , 05004, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Barcelona , 08908, Spain
Barcelona , 08916, Spain
Madrid , 28009, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Sevilla , 41013, Spain
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