EUCTR2004-001105-96-SEActive, not recruitingNot Applicable
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
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Merck KGaA
- Enrollment
- 1,100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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