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A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

NCT00449033 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 904

Last updated 2015-04-23

Study results available
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Summary

Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Sorafenib (Nexavar, BAY43-9006)

Multikinase inhibitor, Sorafenib 400 mg po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV

DRUG

Placebo

Placebo 2 tablets po bid; applied in combination with chemotherapy components: Gemcitabine 1250 mg/m\^2 IV, Cisplatin 75 mg/m\^2 IV

DRUG

Gemcitabine

Chemotherapy component; Gemcitabine 1250 mg/m\^2 IV

DRUG

Cisplatin

Chemotherapy component; Cisplatin 75 mg/m\^2 IV

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-04-30
Completion
2011-06-30

Countries

  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Cyprus
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

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 NCT00449033 on ClinicalTrials.gov