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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT01366131
Phase
PHASE2
Status
Completed

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MEGF0444A — DRUG
    Intravenous repeating dose
  • bevacizumab — DRUG
    Intravenous repeating dose
  • carboplatin — DRUG
    Intravenous repeating dose
  • paclitaxel — DRUG
    Intravenous repeating dose
  • placebo — DRUG
    Intravenous repeating dose

Study Details

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.

Key Dates

First listed
Jun 3, 2011
Start date
Jun 30, 2011
Status verified
Nov 2016
Primary completion
Feb 28, 2013

Study Design

Enrollment
104 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Experimental: B

Primary Outcome Measure

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 ]

Locations (20)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35205-
-Hot SpringsArkansas71913-
-Santa MonicaCalifornia90404-
-OrlandoFlorida32904-
-Port Saint LucieFlorida34952-
-St. PetersburgFlorida33719-
-TampaFlorida33603-
-MariettaGeorgia30060-
-IndianapolisIndiana46260-
-WichitaKansas67214-3728-
-BurnsvilleMinnesota55337-
-Las VegasNevada89148-
-AlbanyNew York12208-
-ColumbusOhio43219-
-PortlandOregon97239-
-HersheyPennsylvania17033-
-NashvilleTennessee37203-
-AustinTexas78731-
-Fort WorthTexas76104-
-VancouverWashington98684-

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