Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC.

Merck KGaA, Darmstadt, Germany1 site in 1 country1,861 target enrollmentOctober 2004

ConditionsNon Small Cell Lung Cancer (NSCLC)

Interventionscetuximab + cisplatin + vinorelbine cisplatin + vinorelbine

Drugscetuximab + cisplatin + vinorelbine cisplatin + vinorelbine

Overview

Phase: Phase 3
Intervention: cetuximab + cisplatin + vinorelbine
Conditions: Non Small Cell Lung Cancer (NSCLC)
Sponsor: Merck KGaA, Darmstadt, Germany
Enrollment: 1861
Locations: 1
Primary Endpoint: Overall Survival Time (OS)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2004

End Date

May 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck KGaA, Darmstadt, Germany

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV
•Immunohistochemical evidence of EGFR expression on tumor tissue
•Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions must not lie in an irradiated area

Exclusion Criteria

•Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR-targeting therapy
•Previous chemotherapy for NSCLC
•Documented or symptomatic brain metastasis
•Superior vena cava syndrome contra-indicating hydration
•Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

Arms & Interventions

Cetuximab plus chemotherapy

cetuximab + cisplatin + vinorelbine

Intervention: cetuximab + cisplatin + vinorelbine

Chemotherapy alone

cisplatin + vinorelbine alone

Intervention: cisplatin + vinorelbine

Outcomes

Primary Outcomes

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

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

Secondary Outcomes

Progression-free Survival Time(Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)
Best Overall Response Rate(Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)
Disease Control Rate(Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status(at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning(at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)
A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations(Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.)
Safety - Number of Patients Experiencing Any Adverse Event(time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007)