Small Cell Lung Cancer (SCLC)
Conditions
Brief summary
Objective Response Rate (ORR): The percentage of participants who show a confirmed complete response (no detectable cancer) or confirmed partial response (reduced tumor size) as assessed by blinded independent central review., Overall Survival (OS): The time interval from the date of randomization to the date of death due to any cause.
Detailed description
ORR as assessed by the investigator, progression-free survival, duration of response, disease control rate, time to response, PROs measures of health-related quality of life, adverse events, antidrug antibody prevalence, correlation of B7-H3 protein expression in tumor tissue with clinical outcomes, and PK.
Interventions
DRUGTOPOTECAN
Sponsors
Daiichi Sankyo Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR): The percentage of participants who show a confirmed complete response (no detectable cancer) or confirmed partial response (reduced tumor size) as assessed by blinded independent central review., Overall Survival (OS): The time interval from the date of randomization to the date of death due to any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR as assessed by the investigator, progression-free survival, duration of response, disease control rate, time to response, PROs measures of health-related quality of life, adverse events, antidrug antibody prevalence, correlation of B7-H3 protein expression in tumor tissue with clinical outcomes, and PK. | — |
Countries
Austria, Belgium, Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Spain
Outcome results
None listed