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

Sponsor
Merck KGaA, Darmstadt, Germany
Study ID
NCT00148798
Phase
PHASE3
Status
Completed

Conditions

  • Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

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

Interventions

  • cetuximab + cisplatin + vinorelbine — DRUG
    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.
  • cisplatin + vinorelbine — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 31, 2004
Status verified
Jun 2014
Primary completion
Jul 31, 2007
Completion
May 31, 2012

Study Design

Enrollment
1,861 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cetuximab plus chemotherapy
    cetuximab + cisplatin + vinorelbine
  • Active Comparator: Chemotherapy alone
    cisplatin + vinorelbine alone

Primary Outcome Measure

Overall Survival Time (OS) [ Time Frame: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007 ]

Related Studies