Alflutinib Mesylate Versus Gefitinib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer （FLAG）

Inclusion criteria

• ✓. Subjects must meet all the following criteria to be enrolled in this study: subjects will voluntarily participate and sign a written informed consent.
• ✓. Male or female, aged at least 18 years.
• ✓. ECOG performance status of 0 to 2. Life expectancy of at least 12 weeks.
• ✓. Patients had histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma not amenable to curative surgery or radiotherapy.
• ✓. The tumour harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R).
• ✓. Tumour tissue sample in a quantity sufficient to allow for central analysis of EGFR mutation status.
• ✓. Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy, investigational agents) if the disease has no progression during one year.
• ✓. At least one measurable lesion by CT or MRI. The measureable lesion should receive no local treatments (i.e., radiotherapy) or not used for screening biopsies (If there is only one target lesion that must be biopsied, baseline tumor evaluation is required at least 14 days after screening biopsy) and can be accurately measured at baseline with the longest diameter greater than 10 mm at baseline (if it is a lymph node, short diameter greater than 15 mm is required). If the lesions located at the regions which were previously treated are confirmed to progress, they can be chosen as lesion according to RECIST Version 1.1

Exclusion criteria