Phase II study of Erlotinib monotherapy in EGFR mutation-negative lung adenocarcinoma excluded biomarkers against EGFR-TKI treatment

INTERVENTION: Erlotinib 150mg/day CONDITION: lung adenocarcinoma PRIMARY OUTCOME: Progression‐Free Survival (PFS) SECONDARY OUTCOME: Response Rate (RR), Overall Survival (OS), Safety, Quality of life (QOL) INCLUSION CRITERIA: 1) Histologically or cytologically proven stage IIIB, IV or relapsed lung adenocarcinoma. 2) Tumor specimen is available for biomarker analysis 3) Patients without activating EGFR mutation, EML4‐ALK fusion gene, K‐Ras mutation and MET protein over expression 4) Patients who have previously treated chemotherapy 5) Measurable region evaluable according to the RECIST 6) ECOG performance status of 0‐1 7) Expected to be observed for at least 2 weeks in a hospital or in a comparable institution after the initiation of erlotinib treatment 8) Patients aged 20 years or older 9) Sufficient function of main organ 10) Patients who are considered to survive for more than 3 months 11) Written informed consent