Non-small cell lung cancer
Conditions
Brief summary
ORR is defined as the proportion of patients who have measurable disease at baseline and achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by an independent review committee (IRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1., Incidence of DLT(s) (ie, percentage of patients who had DLTs) per dose level during the first 21 days of treatment in the safety run-in cohorts.
Detailed description
PFS is defined as the time from the date of the first dose until the date of objective disease progression or death (whichever comes first) as assessed by IRC per RECIST Version 1.1., OS is defined as the time from the date of first dose until death due to any cause., DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of progressive disease (PD) or death from any cause (whichever comes first) as assessed by IRC per RECIST Version 1.1., DCR is defined as the proportion of patients who achieve a CR, PR, or stable disease (SD) as assessed by IRC per RECIST Version 1.1., Incidence of TEAEs and clinical laboratory abnormalities.
Interventions
DRUGTrodelvy 200 mg powder for concentrate for solution for infusion
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGCisplatin 1 mg/ml Concentrate for Solution for Infusion
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR is defined as the proportion of patients who have measurable disease at baseline and achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later as assessed by an independent review committee (IRC) according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1., Incidence of DLT(s) (ie, percentage of patients who had DLTs) per dose level during the first 21 days of treatment in the safety run-in cohorts. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS is defined as the time from the date of the first dose until the date of objective disease progression or death (whichever comes first) as assessed by IRC per RECIST Version 1.1., OS is defined as the time from the date of first dose until death due to any cause., DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of progressive disease (PD) or death from any cause (whichever comes first) as assessed by IRC per RECIST Version 1.1., DCR is defined as the proportion of patients who achieve a CR, PR, or stable disease (SD) as assessed by IRC per RECIST Version 1.1., Incidence of TEAEs and clinical laboratory abnormalities. | — |
Countries
France, Germany, Italy, Spain
Outcome results
None listed