Study Evaluating the Safety and Efficacy of MEGF0444A in Combination With Carboplatin, Paclitaxel and Bevacizumab in Patients With Advanced or Recurrent Non-Squamous Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy for Advanced Disease (NILE)
NCT ID: NCT01366131
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
104 participants
INTERVENTIONAL
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
MEGF0444A
Intravenous repeating dose
bevacizumab
Intravenous repeating dose
carboplatin
Intravenous repeating dose
paclitaxel
Intravenous repeating dose
B
bevacizumab
Intravenous repeating dose
carboplatin
Intravenous repeating dose
paclitaxel
Intravenous repeating dose
placebo
Intravenous repeating dose
Interventions
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MEGF0444A
Intravenous repeating dose
bevacizumab
Intravenous repeating dose
carboplatin
Intravenous repeating dose
paclitaxel
Intravenous repeating dose
placebo
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* ECOG performance status of 0 or 1
* Life expectancy \>12 weeks
* Measurable disease, as defined by RECIST 1.1
* Adequate hematologic and end organ function
Exclusion Criteria
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
* Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
* Pregnant and lactating women
* Active infection requiring IV antibiotics
Bevacizumab-Specific Exclusions:
* Histologically or cytologically documented inoperable, locally advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
* Evidence of tumor invading major blood vessels on imaging
* Evidence of central nervous system (CNS) metastases
* History of stroke or transient ischemic attacks (TIAs) within 6 months prior to Day 1
* Significant vascular disease within 6 months prior to Day 1
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ina Rhee, M.D., Ph.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Birmingham, Alabama, United States
Hot Springs, Arkansas, United States
Santa Monica, California, United States
Orlando, Florida, United States
Port Saint Lucie, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Marietta, Georgia, United States
Indianapolis, Indiana, United States
Wichita, Kansas, United States
Burnsville, Minnesota, United States
Las Vegas, Nevada, United States
Albany, New York, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Vancouver, Washington, United States
St Leonards, New South Wales, Australia
Herston, Queensland, Australia
Woodville South, South Australia, Australia
Brno, , Czechia
Ostrava - Poruba, , Czechia
Le Mans, , France
Lyon, , France
Marseille, , France
Marseille, , France
Paris, , France
Saint-Herblain, , France
Toulouse, , France
Essen, , Germany
Gauting, , Germany
Großhansdorf, , Germany
Halle, , Germany
Budapest, , Hungary
Budapest, , Hungary
Székesfehérvár, , Hungary
Tatabánya, , Hungary
Bydgoszcz, , Poland
Gdansk, , Poland
Countries
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References
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von Pawel J, Spigel DR, Ervin T, Losonczy G, Barlesi F, Juhasz E, Anderson M, McCall B, Wakshull E, Hegde P, Ye W, Chen D, Chang I, Rhee I, Reck M. Randomized Phase II Trial of Parsatuzumab (Anti-EGFL7) or Placebo in Combination with Carboplatin, Paclitaxel, and Bevacizumab for First-Line Nonsquamous Non-Small Cell Lung Cancer. Oncologist. 2018 Jun;23(6):654-e58. doi: 10.1634/theoncologist.2017-0690. Epub 2018 Feb 7.
Other Identifiers
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GO27811
Identifier Type: OTHER
Identifier Source: secondary_id
MEF4984g
Identifier Type: -
Identifier Source: org_study_id