Status:
COMPLETED
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
Lead Sponsor:
OncoMed Pharmaceuticals, Inc.
Collaborating Sponsors:
Celgene Corporation
Conditions:
Nonsquamous Nonsmall Cell Neoplasm of Lung
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief 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 ca...
Detailed 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 (i...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2017
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT02259582
Start Date
February 1 2015
End Date
April 7 2017
Last Update
September 9 2020
Active Locations (45)
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1
Desert Hematology Oncology Medical Group, Inc.
Rancho Mirage, California, United States, 92270
2
University of California, San Francisco
San Francisco, California, United States, . 94143-1705
3
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, United States, 06510-3221
4
Ocala Oncology Center
Ocala, Florida, United States, 34471