Study Question

Study Question

• Study Question

• In a randomized, prospective, Phase III study comparing erlotinib to Platinum based doublet chemo as first line therapy EGFR mutation positive

• Endpoints

• Primary Endpoint
• Progression free survival (PFS)
• Secondary Endpoints
• Overall survival (OS)
• Objective Response Rate (ORR)

• Study Population

• Stage IIIB/IV NSCLC, ECOG 0-2, chemo-naïve, EGFR mutation positive (exon 19/21)

21% of patient samples tested were EGFR mutation positive

• 21% of patient samples tested were EGFR mutation positive

• Overall survival no different but majority of patients crossed over at progression

• No relevant safety concerns

• First trial in western population to show erlotinib superior to chemo in terms of ORR and PFS in EGFR mutation positive patients.

This is the first study in Caucasian population of EGFR TKI versus chemo as first line therapy

• This is the first study in Caucasian population of EGFR TKI versus chemo as first line therapy

• Further support for EGFR mutation analysis in appropriate patients

• Those with activating mutations should be considered for first line GFR TKI therapy