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)

November 1, 2016 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • St. Leonards, New South Wales, Australia, 2065
    • Queensland
      • Herston, Queensland, Australia, 4029
    • South Australia
      • Woodville South, South Australia, Australia, 5011
  • Czech Republic
      • Brno, Czech Republic, 656 53
      • Ostrava - Poruba, Czech Republic, 708 52
  • France
      • Le Mans, France, 72037
      • Lyon, France, 69373
      • Marseille, France, 13273
      • Marseille, France, 13915
      • Paris, France, 75571
      • Saint Herblain, France, 44805
      • Toulouse, France, 31059
  • Germany
      • Essen, Germany, 45122
      • Gauting, Germany, 82131
      • Grosshansdorf, Germany, 22927
      • Halle, Germany, 06120
  • Hungary
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1121
      • Szekesfehervar, Hungary, 8000
      • Tatabánya, Hungary, 2800
  • Poland
      • Bydgoszcz, Poland, 85-796
      • Gdansk, Poland, 80-952
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Santa Monica, California, United States, 90404
    • Florida
      • Orlando, Florida, United States, 32904
      • Port Saint Lucie, Florida, United States, 34952
      • St Petersburg, Florida, United States, 33719
      • Tampa, Florida, United States, 33603
    • Georgia
      • Marietta, Georgia, United States, 30060
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Kansas
      • Wichita, Kansas, United States, 67214-3728
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
    • Nevada
      • Las Vegas, Nevada, United States, 89148
    • New York
      • Albany, New York, United States, 12208
    • Ohio
      • Columbus, Ohio, United States, 43219
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78731
      • Fort Worth, Texas, United States, 76104
    • Washington
      • Vancouver, Washington, United States, 98684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: bevacizumab
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
Drug: MEGF0444A
Intravenous repeating dose
Experimental: B
Drug: placebo
Intravenous repeating dose
Drug: bevacizumab
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: Up to 24 months
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Objective response (partial response plus complete response) as determined by the Investigator using RECIST 1.1
Time Frame: Up to 24 months
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)
Time Frame: Up to 24 months
Up to 24 months
Overall survival (defined as the time from randomization until death from any cause)
Time Frame: Up to 24 months
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Ina Rhee, M.D., Ph.D., Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

June 2, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (Estimate)

June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEF4984g
  • GO27811 (Other Identifier: Hoffmann-La Roche)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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