Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT (Positron Emission Tomography-Computed Tomography) scan. In case of isolated CNS progression which may or may not be accompanied by asymptomatic systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients whose intracranial disease will progress further, brain radiotherapy (in the form of SRS or WBRT) will be administered; treatment with AZD9291 will be interrupted and re-initiated at a standard dose after the end of radiotherapy course in the absence of symptomatic systemic progression. The treatment will be continued until symptomatic systemic progression, unacceptable toxicity or further intracranial progression following brain radiotherapy administration (whichever occurs first). All patients will be followed until death or 5 years.
Name: AZD9291
Description: Patients will receive TAGRISSO. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT scan.
Measure: Intracranial overall response rate as defined by modified RECIST Time: 5 yearsDescription: Patients will receive TAGRISSO. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT scan.
Measure: Intracranial disease control rate (IDCR) as defined by mRECIST Time: 5 yearsDescription: Patients will receive TAGRISSO. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT scan.
Measure: median time to intracranial response (mTTIR) as defined by mRECIST Time: 5 yearsDescription: Patients will receive TAGRISSO. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT scan.
Measure: median intracranial progression free survival (mIPFS) as defined by mRECIST Time: 5 yearsAllocation: Non-Randomized
Single Group Assignment
There are 2 SNPs
- Exon 19 deletion, L858R, T790M and uncommon sensitizing EGFR mutations in treatment-naïve patients are allowed. --- L858R ---
- Exon 19 deletion, L858R, T790M and uncommon sensitizing EGFR mutations in treatment-naïve patients are allowed. --- L858R --- --- T790M ---
erlotinib or afatinib) in whom T790M was diagnosed in the tumor specimen or ctDNA after testing it following the most recent disease progression. --- T790M ---
erlotinib or afatinib) who progressed unrelated to T790M (T790M-). --- T790M ---
erlotinib or afatinib) who progressed unrelated to T790M (T790M-). --- T790M --- --- T790M ---
6. T790M is allowed. --- T790M ---