Inclusion Criteria:

For inclusion in the trial, all of the following inclusion criteria must be fulfilled:

• Subject has given written informed consents before any trial-related activities are
• carried out
• Male or female, ≥18 years of age at the time of informed consent, inpatient or outpatient
• Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIB NSCLC with
• pleural effusion or stage IV
• Presence of at least 1 uni-dimensionally measurable index lesion, whereby index lesions
• must not lie in a previously irradiated area
• ECOG performance status of 0 or 1 at inclusion in the trial
• 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
• Glomerular filtration rate (GFR) ≥60 mL/min
• The GFR is to be based on the Cockroft-Gault formula for creatinine clearance:
• C x (140-age [years] x weight [kg])
• GFR (mL/min) = 72 x serum creatinine (mg/dL)
• where C = 0.85 for female subjects and C = 1.00 for male subjects
• Effective contraception i.e., barrier method (condoms, diaphragm), oral, injectable or
• implant birth control, for both male and female subjects during the whole trial period
• and for at least 6 months after the end of trial treatment, if the risk of conception exists
• Recovered from relevant toxicities prior to inclusion in the trial

Exclusion Criteria:

Subjects are not eligible for this trial if they fulfill any of the following exclusion criteria:

• Previous exposure to EGFR-targeting therapy
• Previous chemotherapy for NSCLC; neo-adjuvant or adjuvant (radio-)chemotherapy is
• allowed if it was finished 6 months prior to start of trial treatment and no more than 300
• mg/m² cisplatin was administered
• Major surgery within 30 days prior to inclusion in the trial
• Prior chest irradiation within 90 days prior to inclusion in the trial (palliative radiation
• of bone lesions is allowed)
• Participation in another clinical trial or treatment with any investigational agent(s)
• within 30 days prior to inclusion in the trial
• Concurrent chronic systemic immune therapy, chemotherapy for disease other than
• cancer, or hormone therapy for the treatment of cancer not indicated in the trial 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