Patients will receive AZD9291 at a dose of 80 mg once daily. Systemic evaluation will be done by PET-CT scan after 6 weeks. In responding patients AZD9291 will be given orally 80 mg daily for 12 weeks. Non-responding patients will receive AZD9291 for the period of 6 or 12 weeks (according to the results of response assessment at each time-point).
Description: assessed by PET-CTMeasure: Overall Response Rate as defined by RECIST 1.1 Time: 12 weeks
Description: mPFS measured by Kaplan-Meier method.Measure: mPFS measured by Kaplan-Meier method. Time: 2 years
Description: Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapyMeasure: Comparing GTV (Gross tumor volume) before and after the neoadjuvant therapy Time: 2 years
Single Group Assignment
There is one SNP
3. Treatment-naïve stage IIIA/B NSCLC with an activating sensitizing EGFR mutation/T790M • Uncommon sensitizing EGFR mutations are allowed. --- T790M ---
Exclusion criteria 1. EGFR TKI - resistant EGFR mutations (e.g., insertion in exon 20) 2. T790M is allowed. --- T790M ---