Patients with locally-advanced or metastatic EGFRm (Ex19del and/or L858R) Non-Small Cell Lung Cancer.
Conditions
Brief summary
Progression-free survival (PFS) using Investigator assessment as defined by RECIST 1.1.
Detailed description
OS; Landmark OS at 1, 2, and 3 years; ORR, DoR; depth of response; DCR by Investigator, PFS2; TFST; TSST, Change from baseline and time to deterioration in EORTC QLQ-C30; Change from baseline and time to deterioration in EORTC QLQ-LC13, Steady-state plasma concentrations and appropriate PK parameters (CLss/F, Cmax,ss Cmin,ss and AUCss) of osimertinib and its metabolite, AZ5104 will be summarized., Concordance of EGFR mutation status between the local EGFR mutation test and the central cobas® EGFR Mutation Test v2 results from tumor samples with evaluable results., PFS by Investigator by plasma EGFR mutation status.
Interventions
DRUGTAGRISSO 80 mg film-coated tablets
DRUGCARBOPLATIN
DRUGCISPLATIN
DRUGPEMETREXED
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) using Investigator assessment as defined by RECIST 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS; Landmark OS at 1, 2, and 3 years; ORR, DoR; depth of response; DCR by Investigator, PFS2; TFST; TSST, Change from baseline and time to deterioration in EORTC QLQ-C30; Change from baseline and time to deterioration in EORTC QLQ-LC13, Steady-state plasma concentrations and appropriate PK parameters (CLss/F, Cmax,ss Cmin,ss and AUCss) of osimertinib and its metabolite, AZ5104 will be summarized., Concordance of EGFR mutation status between the local EGFR mutation test and the central cobas® EGFR Mutation Test v2 results from tumor samples with evaluable results., PFS by Investigator by plasma EGFR mutation status. | — |
Countries
Czechia, France
Outcome results
None listed