First-line patients with extensive disease small-cell lung cancer (SCLC)
Conditions
Brief summary
Maintenance participants alive and progression free (APF12)
Detailed description
Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18), Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1, Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1, Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1, Overall survival (OS) in maintenance participants, The safety and tolerability profile of study intervention in SCLC, The pharmacokinetics of durvalumab and AZD2811, Disease-related symptoms & Health-related QoL measured by EORTC QLQ-LC30 & EORTC QLQ-LC13
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance participants alive and progression free (APF12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18), Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1, Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1, Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1, Overall survival (OS) in maintenance participants, The safety and tolerability profile of study intervention in SCLC, The pharmacokinetics of durvalumab and AZD2811, Disease-related symptoms & Health-related QoL measured by EORTC QLQ-LC30 & EORTC QLQ-LC13 | — |
Countries
Spain