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



Status:Completed
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:8/22/2018
Start Date:February 2015
End Date:April 7, 2017

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A 2-Arm Phase 2 Double-Blind Randomized Study of Carboplatin, Pemetrexed Plus Placebo Versus Carboplatin, Pemetrexed Plus Truncated Demcizumab as First-Line Treatment in Subjects With Stage IV Non-Squamous Non-Small Cell Lung Cancer

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.

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.

Main Inclusion Criteria:

1. Signed Informed Consent Form

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

Main Exclusion Criteria:

1. Histologically or cytologically documented, advanced, mixed non-small cell and small
cell tumors or mixed adenosquamous carcinomas

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
We found this trial at
19
sites
Annapolis, Maryland 21401
Principal Investigator: Peter Graze, MD
Phone: 443-481-4884
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Grace Dy, MD
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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433 Southwest 10th Street
Ocala, Florida 34471
Principal Investigator: Craig H. Reynolds, MD
Phone: 352-732-4938
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Binghamton, New York 13905
Principal Investigator: Ronald P. Harris, MD
Phone: 607-763-8065
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Camperdown, New South Wales 2050
Principal Investigator: Michael Joseph Boyer, MD
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Canton, Ohio 44718
Principal Investigator: Nashat Gabrail, MD
Phone: 330-492-3345
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: Afshin Dowlati, MD
Phone: 216-844-1228
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
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Dallas, Texas 75246
Principal Investigator: Kartik Konduri,, MD
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Detroit, Michigan 48202
Principal Investigator: Haythem Ali, MD
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Detroit, Michigan 48201
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Galveston, Texas
Principal Investigator: Maurice Willis, MD
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Gastonia, North Carolina 28054
Principal Investigator: William Charles, MD
Phone: 704-865-5210
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New Haven, Connecticut 06520
Principal Investigator: Anne Chiang, MD
Phone: 203-785-6879
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Nyack, New York 10960
Principal Investigator: Bradley Cohen, MD
Phone: 845-362-1750
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Rancho Mirage, California
Principal Investigator: Luke Dreisbach, MD
Phone: 760-568-3613
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San Francisco, California 94143
Principal Investigator: Matthew Gubens, MD
Phone: 415-514-6241
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Sherman, Texas 75090
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Skokie, Illinois 60076
Principal Investigator: Edward H Kaplan, MD
Phone: 847-675-3900
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Vancouver, Washington 98683
Principal Investigator: DAVID A SMITH, MD
Phone: 360-449-6521
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