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

Phase 3

Completed

• Conditions: Non Small Cell Lung Cancer (NSCLC)
• Interventions: Drug: cetuximab + cisplatin + vinorelbine; Drug: cisplatin + vinorelbine

• Registration Number: NCT00148798
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-08
• Primary Completion: 2007-07
• Results First Submitted: 2011-08-24
• Results First Submitted QC: 2011-08-24
• Results First Posted: 2011-10-04
• Study Completion: 2012-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1861

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cetuximab plus chemotherapy	cetuximab + cisplatin + vinorelbine	cetuximab + cisplatin + vinorelbine
Chemotherapy alone	cisplatin + vinorelbine	cisplatin + vinorelbine alone

Primary Outcome Measures

Name	Time	Method
Overall Survival Time (OS)	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 Outcome Measures

Name	Time	Method
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	Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.; Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
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	The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
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	The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).
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	Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
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	Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.
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.	Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.
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	Please refer to Adverse Events section for further details

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wolverhampton, United Kingdom