Small Cell Lung Cancer
Conditions
Brief summary
Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR), Overall Survival (OS)
Detailed description
Progression-free survival (PFS) based on BICR assessment per RECIST v1.1., Duration of response (DoR) based on BICR assessment per RECIST v1.1., Change from baseline at Week 12 in physical functioning as measured by the physicalfunctioning domain of the EORTC QLQ-C30., Change from baseline at Week 12 in Global Health Status (GHS)/Quality of life (QoL) as measured by the EORTC QLQ-C30 GHS/QoL scale
Interventions
DRUGTOPOTECAN
DRUGABBV-706
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response (OR) as Measured by Overall Response Rate (ORR) Based on Blinded Independent Central Review (BICR), Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) based on BICR assessment per RECIST v1.1., Duration of response (DoR) based on BICR assessment per RECIST v1.1., Change from baseline at Week 12 in physical functioning as measured by the physicalfunctioning domain of the EORTC QLQ-C30., Change from baseline at Week 12 in Global Health Status (GHS)/Quality of life (QoL) as measured by the EORTC QLQ-C30 GHS/QoL scale | — |
Outcome results
None listed