Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
PFS is defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any cause., OS is defined as the time from randomization to death due to any cause.
Detailed description
PFS is defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any cause., ORR is defined as the proportion of subjects who achieved a BOR of CR or PR., DoR is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first., DCR is defined as the proportion of subjects who achieved a BOR of CR, PR, or SD., TTR is defined as the time from randomization to the date of the first documentation of objective response (CR or PR) in responding subjects.
Interventions
DRUGDatopotamab deruxtecan
DRUGDOCETAXEL
Sponsors
Daiichi Sankyo Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS is defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any cause., OS is defined as the time from randomization to death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS is defined as the time from randomization to the earlier of the dates of the first radiographic disease progression or death due to any cause., ORR is defined as the proportion of subjects who achieved a BOR of CR or PR., DoR is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first radiographic disease progression or death due to any cause, whichever occurs first., DCR is defined as the proportion of subjects who achieved a BOR of CR, PR, or SD., TTR is defined as the time from randomization to the date of the first documentation of objective response (CR or PR) in responding subjects. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed