resectable stage IB-IIIA non small cell lung cancer (NSCLC)
Conditions
Interventions
Trade Name: Erbitux
Product Name: ERbitux
Product Code: EMD271786
Pharmaceutical Form: Intravenous infusion
Trade Name: Cisplatin
Product Name: Cisplatin
Pharmaceutical Form: Intravenous infusion
Tr
Sponsors
Dr Ken O'Byrne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed written informed consents· Male or female >=18 years of age· Diagnosis of histologically confirmed NSCLC, stage IB IIIA disease· Presence of unidimensionally measurable disease using RECIST criteria. Life expectancy of >= 3 months. Performance status 0-1. Effective contraception for both male and female patients if risk of conception exists. Neutrophils >= 1.5 x 109/L, platelets >= 100 x 109/L, and hemoglobin >= 9 g/dL. Bilirubin level = 60 ml/min 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
Exclusion criteria: Proven or symptomatic brain metastases· Stage IIIB or IV disease. Major surgery within 4 weeks prior to study entry. Chest irradiation within 4 weeks prior to study entry. Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol. Any prior chemotherapy for the current disease or within 5 years of the current diagnosis. Any investigational agent(s) within 4 weeks prior to entry. Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy. Known drug abuse· Pregnancy (absence confirmed by serum/urine b-HCG) or breast-feeding. Legal incapacity or limited legal capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the objective radiological response and complete pathological response rates to cetuximab administered in combination with cisplatin and gemcitabine in patients with stage IB-IIIA NSCLC prior to surgery;Secondary Objective: To determine the safety of the combination both before and after surgery To record the successful resection rate following induction therapy To determine the overall survival time To determine relapse free survival To attempt to identify biomarkers predictive for response and resistance to therapy;Primary end point(s): Confirmed response to treatment. THe primary target vriable will be measured according to modified RECIST. | — |
Countries
Ireland
Outcome results
None listed