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Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)

NCT00148798 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1861

Last updated 2014-06-25

Study results available
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Summary

The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.

Conditions

  • Non Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

cetuximab + cisplatin + vinorelbine

cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.

DRUG

cisplatin + vinorelbine

cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Robert Pirker, Professor · Universitätsklinik für Innere Medizin I, Wien

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2007-07-31
Completion
2012-05-31

Countries

  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Chile
  • Czechia
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Ireland
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT00148798 on ClinicalTrials.gov