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

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2004-001105-96-GB
• Date of registration: 18/07/2005
• Prospective Registration: No
• Primary sponsor: Merck KGaA
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 26/10/2004
• Target sample size: 1100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-001105-96
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Czech Republic, Hungary, Italy, Slovakia, Spain, Sweden, United Kingdom

Key inclusion & exclusion criteria

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Trade Name: Erbitux
Product Name: Erbitux
Product Code: EMD271786
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cetuximab
Current Sponsor code: EMD271786
Other descriptive name: C225
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: not less then
Concentration number: 2 mg / ml-

Primary Outcome(s)

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:
Progression-free survival (PFS) time
Response rate
Disease control rate
Safety
Quality of life (QoL)
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.

Secondary ID(s)

EMR62202-046

2004-001105-96-HU

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 25/06/2016
• Date Completed: 19/04/2012
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2004-001105-96/results