Non-small cell lung cancer locally advanced
Conditions
Interventions
Trade Name: Erbitux
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: CISPLATIN
CAS Number: 15663271
Concentra
Sponsors
NKI-AVL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 years of age 2. Histologically or cytologically confirmed diagnosis of NSCLC 3. Stage II/III non-operable disease , without malignant pleural effusion 4. Presence of at least one measurable target lesion 5. Acceptable pulmonary function as defined by a Fev1 of =30% and a DLCO of =40% of predicted 6. Life expectancy of at least 6 months 7. WHO performance 0-1 8. Adequate hematological, renal and hepatic functions a. absolute neutrophil count > 2 x 109/l b. platelet count > 100 x 109/l c. total bilirubin 50ml/min; measured or calculated g. Urine dipstick for proteinuria =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Concurrent active malignancy other than localized, nonmelanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 3 years or more before study entry and the patient had remained disease free); 2. Prior: a. Ipsilateral radiotherapy to the chest; b. Chemotherapy within the last 5 years; c. Immunotherapy or treatment with murine monoclonal antibodies, Cetuximab, or other EGFR inhibitors. 3. Pregnant or breast-feeding patients 4. WHO performance score > 2 5. Other serious diseases, such as heart failure, angina pectoris, myocardial infarction within the last 6 months, uncontrolled hypertension 6. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed with the patient before registration in the trial. 7. Participation in other trial with investigational drug or treatment modality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase 1: To assess the safety of Cetuximab added to concurrent CRT Phase 2: To assess the activity of combined regimen of Cetuximab with concurrent CRT ;Secondary Objective: Phase 1: Chronic toxicity Phase 2: To assess the efficacy of combined treatment of low-dose Cisplatin and Cetuximab with radiotherapy in locally advanced NSCLC ;Primary end point(s): Phase I: Adverse events (dose-limiting toxicities defined in Paragraph 9.4) Phase 2: Objective tumour response (According to RECIST) | — |
Countries
Netherlands
Outcome results
None listed