Small cell lung cancer (SCLC)
Conditions
Brief summary
1. Progression-free survival in the PAS, 2. Overall survival in the PAS
Detailed description
1. Progression free survival in the FAS, 2. Overall survival in the FAS, 3. Confirmed objective response rate in the PAS and FAS population, 4. Duration of response in the PAS and FAS population, 5. Progression-free survival rates at 6 months and at 12 months in the PAS and FAS population, 6. Overall survival rates at 12 months and 24 months in the PAS and FAS population, 7. Time to confirmed deterioration in the PAS and FAS population, 8. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, 9. Severity for cytokine-release syndrome (CRS) will also be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS consensus grading scale, 10. Minimum serum concentration [Cmin]of tiragolumab and atezolizumab at specified timepoints, 11. Maximum serum concentration [Cmax] of tiragolumab and atezolizumab at specified timepoints, 12. Prevalence of ADAs to tiragolumab and atezolizumab at baseline and during the study, 13. Change in EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L) index-based and Visual Analog Scale scores at specified timepoints during the study
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Progression-free survival in the PAS, 2. Overall survival in the PAS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression free survival in the FAS, 2. Overall survival in the FAS, 3. Confirmed objective response rate in the PAS and FAS population, 4. Duration of response in the PAS and FAS population, 5. Progression-free survival rates at 6 months and at 12 months in the PAS and FAS population, 6. Overall survival rates at 12 months and 24 months in the PAS and FAS population, 7. Time to confirmed deterioration in the PAS and FAS population, 8. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, 9. Severity for cytokine-release syndrome (CRS) will also be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS consensus grading scale, 10. Minimum serum concentration [Cmin]of tiragolumab and atezolizumab at specified timepoints, 11. Maximum serum concentration [Cmax] of tiragolumab and atezolizumab at specified timepoints, 12. Prevalence | — |
Countries
Greece, Italy, Poland