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A Study of Bevacizumab in Combination With Standard of Care Treatment in Participants With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

NCT01351415 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 485

Last updated 2017-09-18

Study results available
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Summary

This open-label, randomized, multicenter study will evaluate the efficacy and safety of bevacizumab (Avastin) in combination with standard of care (SOC) treatment in participants with advanced non-squamous NSCLC. Participants will be enrolled at documentation of progression of disease (PD) after 4-6 cycles of first-line treatment with bevacizumab plus a platinum doublet-containing therapy and a minimum of two cycles of bevacizumab maintenance treatment prior to PD. Participants will be randomly assigned to one of two treatment arms to receive either bevacizumab plus SOC treatment or SOC treatment alone.

Conditions

  • Non-Squamous Non-Small Cell Lung Cancer

Interventions

DRUG

Bevacizumab

Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.

DRUG

Docetaxel

Docetaxel 60 or 75 milligram per meter square (mg/m\^2) on Day 1 every 21 days.

DRUG

Erlotinib

Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.

DRUG

Pemetrexed

Pemetrexed 500 mg/m\^2 IV over 10 minutes on Day 1 every 21 days.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-25
Primary Completion
2016-06-25
Completion
2016-06-25

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Japan
  • Lebanon
  • Mexico
  • Netherlands
  • Oman
  • Slovakia
  • Spain
  • United Arab Emirates

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01351415 on ClinicalTrials.gov