Erlotinib as 1st Line Treatment in NSCLC Stage IIIB/IV

Inclusion Criteria:

• Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC
• No previous therapy for advanced/metastatic NSCLC is allowed
• age >18 years
• bidimensionally measurable disease
• non-smokers (or ex-smokers with less than 5 pack-years smoking history)
• adenocarcinoma histology
• performance status (WHO) 0-3
• adequate liver (serum bilirubin <1.5 times the upper normal limit (UNL); AST and ALT <2.5 times the UNL in the absence of demonstrable liver metastases, or <5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine <1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function
• previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields
• patient able to take oral medication
• tissue sample for tumour mutational analysis is required

Exclusion Criteria:

• serious chronic skin conditions (e.g. psoriasis, eczema) that would preclude study participation
• active infection
• history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
• malnutrition (loss of ≥ 20% of the original body weight)
• performance status: 4
• psychiatric illness or social situation that would preclude study compliance
• pregnant or lactating women