A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Vallejo, California.

Sponsor
Genentech, Inc.
Study ID
NCT00130728
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
  • erlotinib HCl — DRUG
    oral erlotinib HCl 150 mg/day orally
  • placebo — DRUG
    intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Study Details

This is a Phase III, multicenter, placebo-controlled, double-blind, randomized study. Approximately 650 patients will be randomized in a 1:1 ratio to one of two treatment arms.

Key Dates

First listed
Aug 16, 2005
Start date
Jun 8, 2005
Status verified
Dec 2020
Primary completion
Jul 15, 2008
Completion
Dec 23, 2019

Study Design

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

Arms

  • Experimental: erlotinib HCl + bevacizumab
    oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
  • Placebo Comparator: erlotinib HCl + placebo
    oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Primary Outcome Measure

Overall Survival (OS) Among All Randomized Patients [ Time Frame: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Kaiser Permanente - VallejoVallejoCalifornia94589-
University Cancer & Blood Center, LLC; ResearchAthensGeorgia30607-
University of Kansas Medical CenterKansas CityKansas66160-
Anne Arundel Health System Research Instit-Annapolis Oncology CtrAnnapolisMaryland21401-

Find similar trials in Vallejo, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Kaiser Permanente - Vallejo· Vallejo, CAUniversity Cancer & Blood Center, LLC; Research· Athens, GAUniversity of Kansas Medical Center· Kansas City, KSAnne Arundel Health System Research Instit-Annapolis Oncology Ctr· Annapolis, MD

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