Erlotinib Treatment Beyond Progression in EGFR Mutant NSCLC

Inclusion Criteria:

• Histologically confirmed stage IIIB/IV NSCLC.
• Investigator confirmed progression according RECIST 1.1 during EGFR TKI treatment within 28 days of the randomization
• Activating mutation (G719A/C/S; Exon 19 insertion/deletion; L858R; L861Q) in the EGFR gene or have had at least partial response with EGFR TKI lasting ≥ 6 months
• Performance status: WHO 0-2
• Measurable disease according to RECIST 1.1
• Patients must be able to comply with study treatments
• Women with child-bearing potential and men with reproductive potential must be willing to practice acceptable methods of birth control during the study
• Neutrophils ≥ 1'000/μl, Platelets ≥ 100'000/μl, Alanine amino transferase ≤ 2.5 × Upper limit of normal (ULN) (< 5 × ULN if liver metastases), Alkaline phosphatase ≤ 2.5 × ULN (< 5 × ULN if liver metastases), Serum bilirubin ≤ 1.5 × ULN, Serum Creatinine ≤ 1.5 × ULN.
• Patient must be able to comply with the protocol

Exclusion Criteria:

• RECIST 1.1 defined disease progression for more than 28 days while on previous EGFR TKI treatment.
• Patient has been treated with any investigational agent for any indication within 4 weeks of study treatment.
• Patient has history of hypersensitivity or intolerance to erlotinib or gefitinib.
• Patient has history of hypersensitivity or intolerance to chemotherapeutic agents used in the study.
• Patient with symptomatic central nervous system metastases
• Patient has known active hepatitis B or C, or HIV infection
• Pregnant or breastfeeding.
• Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study