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A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination with Atezolizumab Compared with Placebo in Combination with Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502482-17-00
Acronym
GO41717
Enrollment
192
Registered
2024-08-19
Start date
2020-05-19
Completion date
2025-11-05
Last updated
2025-08-11

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

Conditions

Non-small cell lung cancer (NSCLC)

Brief summary

1. PFS as determined by the investigator according to RECIST v1.1 in the primary analysis population, 2. Overall Survival (OS) in the primary analysis population

Detailed description

1. Investigator assessed PFS according to RECIST v1.1 in the secondary analysis population, 2. OS in the secondary analysis population, 3. Confirmed ORR as determined by the investigator according to RECIST v1.1, 4. DOR for patients with confirmed ORR as determined by the investigator according to RECIST v1.1, 5. PFS rate at 6 months and 12 months as determined by the investigator according to RECIST v1.1, 6. OS rate at 12 months and 24 months, 7. Time to confirmed deterioration (TTCD) in patient-reported physical functioning and global health status/quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer, 8. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, 9. Severity for CRS will also be determined according to the ASTCT CRS consensus grading scale, 10. Serum concentrations of tiragolumab and atezolizumab at specified timepoints, 11. Prevalence of ADAs to tiragolumab at baseline and incidence of ADAs to tiragolumab during the study, 12. Prevalence of ADAs to atezolizumab at baseline and incidence of ADAs to atezolizumab during the study, 13. Change in EQ-5D-5L index-based and visual analog scale (VAS) scores at specified timepoints during the study (including post-progression)

Interventions

DRUGTiragolumab
DRUGTecentriq 1 200 mg concentrate for solution for infusion

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. PFS as determined by the investigator according to RECIST v1.1 in the primary analysis population, 2. Overall Survival (OS) in the primary analysis population

Secondary

MeasureTime frame
1. Investigator assessed PFS according to RECIST v1.1 in the secondary analysis population, 2. OS in the secondary analysis population, 3. Confirmed ORR as determined by the investigator according to RECIST v1.1, 4. DOR for patients with confirmed ORR as determined by the investigator according to RECIST v1.1, 5. PFS rate at 6 months and 12 months as determined by the investigator according to RECIST v1.1, 6. OS rate at 12 months and 24 months, 7. Time to confirmed deterioration (TTCD) in patient-reported physical functioning and global health status/quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer, 8. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0, 9. Severity for CRS will also be determined according to the ASTCT CRS consensus grading scale, 10. Serum concentrations of tira

Countries

Austria, Germany, Greece, Hungary, Italy, Netherlands, Poland, Spain

Outcome results

None listed

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