Open, randomized, controlled, multicenter phase III study comparing cisplatin / vinoelbine plus cetuximab versus cisplatin / vinorelbine as first-line treament for patients with EGFR-expessing advanced NSCLC - FLEX

Phase 1

• Conditions: Epidermal growth factor receptor-expressing advanced non-small cell lung cancer.; MedDRA version: 7.0Classification code 10061873

• Registration Number: EUCTR2004-001105-96-SK
• Lead Sponsor: Merck KGaA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-06
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

Patient has given written informed consents before any study-related activities are carried out.
Male or female, =18 years of age.
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.
ECOG performance status of =2 at study entry.
White blood count =3 x 109/L with neutrophils =1.5 x 109/L, platelet count =100 x 109/L, and hemoglobin = 5.6 mmol/L (9 g/dL).
Total bilirubin =1.5 x upper limit of normal (ULN) range.
Aspartate aminotransferase (ASAT) and alanine-aminotransferase (ALAT) = 5 x ULN.
Serum creatinine =1.25 ULN and/or creatinine clearance = 60 ml/min.
Effective contraception for both male and female patients if the risk of conception exists.
Recovered from relevant toxicities prior to study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR-targeting therapy.
Previous chemotherapy for NSCLC.
Major surgery within 4 weeks prior to study entry.
Prior chest irradiation within 12 weeks prior to study entry (palliative radiation of bone lesions is allowed).
Treatment with any investigational agent(s) within 4 weeks prior to study entry.
Concurrent chronic systemic immune therapy, chemotherapy for disease other than cancer, or hormone therapy for the treatment of cancer not indicated in the study protocol.
Documented or symptomatic brain metastasis.
Pre-existing ascites grade =2 and/or pericardial effusion grade = 2.
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.
Active infection (infection requiring intravenous [IV] antibiotics), including active tuberculosis, known and declared HIV.
Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current grade 3 or 4 cardio-vascular disorder despite treatment.
Known allergic/hypersensitivity reaction to any of the components of study treatments.
Symptomatic peripheral neuropathy National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grade =2 and/or ototoxicity grade =2, except if due to trauma or mechanical impairment due to tumor mass.
History of significant neurologic or psychiatric disorders including dementia, seizures, bipolar disorder.
Medical or psychological condition that would not permit the patient to complete the study or sign informed consent.
Known drug abuse.
Pregnancy (absence to be confirmed by b-HCG test) or lactation period.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To show superiority in terms of overall survival time of patients receiving platinum-based chemotherapy plus cetuximab as first-line treatment compared with patients receiving the same chemotherapy alone.;Secondary Objective: To compare between the two treatment groups:<br>Progression-free survival (PFS) time <br>Response rate<br>Disease control rate<br>Safety<br>Quality of life (QoL)<br>Cetuximab pharmacokinetics in the cetuximab arm via a population pharmacokinetics approach.;Primary end point(s): The primary end point in this study is the overall survival time defined as the time from the day of randomization to death.