Onderzoek naar de werkzaamheid van toevoeging van Cetuximab aan de combinatie van radiotherapie en Cisplatin bij patiënten met niet-kleincellig longkanker.

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. WHO performance 0-1;

7. Life expectancy of at least 6 months;

8. Adequate haematological, renal and hepatic functions:

A. Absolute neutrophil count > 2x109/l;

B. Platelet count > 100 x 109/l;

C. Total bilirubin < 2 x UNL;

D. ASAT/ALAT < 3 x UNL;

E. Alkaline phosphatase < 5 x UNL;

F. Creatinine < 130 ¦Ìmol/l or creatinine clearance > 50 ml/min; measured or calculated;

G. Urine dipstick for proteinuria < 1+. If urine dipstick is ¡Ý 1, 24 hour urine must demonstrate < 500 mg of protein in 24 hours.

9. No pre-existing sensory neurotoxicity grade >= 2 (CTC);

10. Patients of reproductive potential must agree to practice an effective medically approved contraceptive method during the trial and 3 months afterwards;

11. Expected risk of radiation-induced pulmonary toxicity is not high: V20 =< 36% / MLD =< 20%;

12. Signed written informed consent.

1. Concurrent active malignancy other than localized, non-melanoma skin cancer or carcinoma-in-situ of the cervix (unless definitive treatment was completed 5 years or more before study entry and the patient has 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 > 1;

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.