Skip to content

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide with or Without Tiragolumab (Anti-Tigit Antibody) in Patients with Untreated Extensive-Stage Small Cell Lung Cancer

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502988-37-00
Acronym
GO41767
Enrollment
90
Registered
2024-09-23
Start date
2020-06-19
Completion date
2025-07-31
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small cell lung cancer (SCLC)

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

DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGTiragolumab

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Progression-free survival in the PAS, 2. Overall survival in the PAS

Secondary

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026