This will be a Phase II, open-label, single-arm, multicenter study of the efficacy and safety of osimertinib (80 mg orally once daily) in patients with LM associated with EGFRm+ NSCLC.
Name: 80mg Osimertinib
Description: To investigate the efficacy of osimertinib on LM as measured by OS
Measure: Overall survival Time: Up to 30 monthsDescription: BICR(Blinded independent central review) assessments, based on neuroimaging RANO-LM
Measure: LM ORR(Objective response rate) Time: Up to 30 monthsDescription: BICR(Blinded independent central review) assessments, based on neuroimaging RANO-LM
Measure: LM DoR(Duration of response) Time: Up to 30 monthsDescription: BICR(Blinded independent central review) assessments, based on neuroimaging RANO-LM
Measure: LM DCR(Disease control rate) Time: Up to 30 monthsDescription: BICR(Blinded independent central review) assessments, based on neuroimaging RANO-LM
Measure: LM PFS(Progression-free survival) Time: Up to 30 monthsDescription: To investigate the efficacy of osimertinib in patients with LM associated with EGFRm+ NSCLC on the CSF cytological clearance
Measure: CSF response rate based on CSF cytology Time: Up to 30 monthsAllocation: N/A
Single Group Assignment
There are 2 SNPs
3. Male and female patients must be at least 18 years of age. 4. Patients must have documented (only allowed for EGFRm+ [exon 19 deletions or L858R] in pre-treated patients) and/or confirmed central/local test result showing eligible EGFR mutation status as specified below: - EGFR TKI pre-treated patients: EGFRm+ (exon 19 deletions or L858R), along with valid T790M mutation status 5. --- L858R ---
3. Male and female patients must be at least 18 years of age. 4. Patients must have documented (only allowed for EGFRm+ [exon 19 deletions or L858R] in pre-treated patients) and/or confirmed central/local test result showing eligible EGFR mutation status as specified below: - EGFR TKI pre-treated patients: EGFRm+ (exon 19 deletions or L858R), along with valid T790M mutation status 5. --- L858R --- --- L858R ---
3. Male and female patients must be at least 18 years of age. 4. Patients must have documented (only allowed for EGFRm+ [exon 19 deletions or L858R] in pre-treated patients) and/or confirmed central/local test result showing eligible EGFR mutation status as specified below: - EGFR TKI pre-treated patients: EGFRm+ (exon 19 deletions or L858R), along with valid T790M mutation status 5. --- L858R --- --- L858R --- --- T790M ---
6. EGFR TKI pre-treated patients must have had at least 1 prior EGFR TKI (eg, gefitinib, erlotinib, icotinib, dacomitinib or afatinib) and may have had other lines of therapy 7. If the patients is T790M negative, EXC must be stable following previous EGFR TKI treatment. --- T790M ---
EXC progression is allowed if patients are T790M positive patients 8. ECOG/WHO performance status 0 to 2 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks. --- T790M ---
Exclusion Criteria: 1. EGFR TKI pre-treated patients whose T790M mutation status cannot be determined. --- T790M ---
2. EGFR TKI pre-treated patients with progressing EXC disease who are T790M mutation-negative. --- T790M ---
Patient has previously participated in the present study, except for rescreened patients with T790M mutation-negative disease who were previously screened but were excluded due to progressing EXC disease that has subsequently been stabilized. --- T790M ---