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)
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled 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
2 other identifiers
interventional
104
7 countries
42
Brief Summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of MEGF0444A combined with paclitaxel + carboplatin + bevacizumab therapy in patients with histologically or cytologically documented inoperable, locally advanced, metastatic (Stage IV), or recurrent non-squamous NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 2, 2011
CompletedFirst Posted
Study publicly available on registry
June 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedNovember 2, 2016
November 1, 2016
1.7 years
June 2, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (defined as the time from randomization to the first occurrence of progression based on RECIST 1.1 criteria or death from any cause on study)
Up to 24 months
Secondary Outcomes (3)
Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1
Up to 24 months
Duration of objective response (defined as the first occurrence of a documented objective response until the time of progression or death from any cause on study)
Up to 24 months
Overall survival (defined as the time from randomization until death from any cause)
Up to 24 months
Study Arms (2)
A
EXPERIMENTALB
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically documented inoperable (Stage IV) or recurrent non-squamous non-small cell lung cancer (NSCLC). Diagnoses of non-squamous NSCLC that are based on sputum cytology alone are not acceptable. Mixed tumors should be categorized according to the predominant cell type.
- 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
You may not qualify if:
- Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors,radiotherapy, immunotherapy, hormonal therapy or investigational therapy) before Day 1 of Cycle 1 for the treatment of Stage IV or recurrent NSCLC. Patients who received prior adjuvant chemotherapy or radiotherapy for NSCLC are not excluded if the time interval from completion of adjuvant therapy until disease progression is \> 12 months.
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (42)
Unknown Facility
Birmingham, Alabama, 35205, United States
Unknown Facility
Hot Springs, Arkansas, 71913, United States
Unknown Facility
Santa Monica, California, 90404, United States
Unknown Facility
Orlando, Florida, 32904, United States
Unknown Facility
Port Saint Lucie, Florida, 34952, United States
Unknown Facility
St. Petersburg, Florida, 33719, United States
Unknown Facility
Tampa, Florida, 33603, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Wichita, Kansas, 67214-3728, United States
Unknown Facility
Burnsville, Minnesota, 55337, United States
Unknown Facility
Las Vegas, Nevada, 89148, United States
Unknown Facility
Albany, New York, 12208, United States
Unknown Facility
Columbus, Ohio, 43219, United States
Unknown Facility
Portland, Oregon, 97239, United States
Unknown Facility
Hershey, Pennsylvania, 17033, United States
Unknown Facility
Nashville, Tennessee, 37203, United States
Unknown Facility
Austin, Texas, 78731, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
Vancouver, Washington, 98684, United States
Unknown Facility
St Leonards, New South Wales, 2065, Australia
Unknown Facility
Herston, Queensland, 4029, Australia
Unknown Facility
Woodville South, South Australia, 5011, Australia
Unknown Facility
Brno, 656 53, Czechia
Unknown Facility
Ostrava - Poruba, 708 52, Czechia
Unknown Facility
Le Mans, 72037, France
Unknown Facility
Lyon, 69373, France
Unknown Facility
Marseille, 13273, France
Unknown Facility
Marseille, 13915, France
Unknown Facility
Paris, 75571, France
Unknown Facility
Saint-Herblain, 44805, France
Unknown Facility
Toulouse, 31059, France
Unknown Facility
Essen, 45122, Germany
Unknown Facility
Gauting, 82131, Germany
Unknown Facility
Großhansdorf, 22927, Germany
Unknown Facility
Halle, 06120, Germany
Unknown Facility
Budapest, 1121, Hungary
Unknown Facility
Budapest, 1125, Hungary
Unknown Facility
Székesfehérvár, 8000, Hungary
Unknown Facility
Tatabánya, 2800, Hungary
Unknown Facility
Bydgoszcz, 85-796, Poland
Unknown Facility
Gdansk, 80-952, Poland
Related Publications (1)
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.
PMID: 29438092DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ina Rhee, M.D., Ph.D.
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2011
First Posted
June 3, 2011
Study Start
June 1, 2011
Primary Completion
February 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11