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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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