Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
Progression free survival (PFS) as assessed by blinded independent central review (BICR) based on RECIST v1.1
Detailed description
Overall survival (OS), Progression-free survival (PFS) as assessed by the Investigator per RECIST v1.1, Progression-free survival on the next line of therapy (PFS2) as assessed by local standard clinical practice, Objective response rate (ORR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Duration of response (DoR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Clinical benefit rate (CBR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Disease control rate (DCR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Time to response (TTR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Patient-reported outcome (PRO) of disease-related symptoms, functioning scales, and general health status and overall quality of life, Intracranial progression-free survival (PFS) as assessed by BICR per CNS—RECIST.
Interventions
Sponsors
Daiichi Sankyo Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) as assessed by blinded independent central review (BICR) based on RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS), Progression-free survival (PFS) as assessed by the Investigator per RECIST v1.1, Progression-free survival on the next line of therapy (PFS2) as assessed by local standard clinical practice, Objective response rate (ORR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Duration of response (DoR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Clinical benefit rate (CBR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Disease control rate (DCR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Time to response (TTR) as assessed by BICR and as assessed by the Investigator per RECIST v1.1, Patient-reported outcome (PRO) of disease-related symptoms, functioning scales, and general health status and overall quality of life, Intracranial progression-free survival (PFS) as assessed by BICR per CNS—RECIST. | — |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Poland, Portugal, Spain
Outcome results
None listed