Skip to content

A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study of Tiragolumab in combination with Atezolizumab plus Pemetrexed and Carboplatin/Cisplatin versus Pembrolizumab plus Pemetrexed and Carboplatin/Cisplatin in Patients with previously Untreated Advanced Non-Squamous Non-Small-Cell Lung Cancer

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502031-20-00
Acronym
BO42592
Enrollment
149
Registered
2024-06-07
Start date
2020-12-17
Completion date
2025-08-22
Last updated
2025-09-27

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

Conditions

Non-squamous non-small cell lung cancer (NSCLC)

Brief summary

1. Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2), 2. Investigator-Assessed Progression-free survival (PFS) (Phase 2 and Phase 3), 3. Overall survival (Phase 3)

Detailed description

1. Overall survival (Phase 2), 2. PFS as determined by an independent review facility (IRF) (Phase 3), 3. PFS and OS in patients with PD L1 expression at TC ≥50% and TC ≥1% cut-off, as determined by central testing with Ventana PD-L1 (SP263) assay (Phase 3), 4. PFS at 6 months and 12 months (Phase 3), 5. OS rate at 12 months and 24 months (Phase 3), 6. Confirmed ORR (Phase 3), 7. Duration of response for patients with a confirmed objective response, defined as the time from first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (Phase 2 and Phase 3), 8. Time to confirmed deterioration (TTCD) in patient-reported physical functioning and global health status/quality of life (GHS/QoL), as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain, as measured through the use of the EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) (Phase 2 and Phase 3), 9. Percentage of Participants with Adverse Events (AEs) (Phase 2 and Phase 3), 10. Frequency of patients’ response of the degree they are troubled with treatment symptoms, as assessed through use of the single-item EORTC IL46 (Phase 2 and Phase 3), 11. Serum concentrations of tiragolumab and atezolizumab (Phase 2 and Phase 3), 12. Percentage of participants with anti-drug antibodies (ADAs) to tiragolumab (Phase 2 and Phase 3), 13. Percentage of participants with ADAs to atezolizumab (Phase 2 and Phase 3)

Interventions

DRUGTecentriq 1 200 mg concentrate for solution for infusion
DRUGKEYTRUDA 25 mg/mL 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. Investigator-Assessed Confirmed Objective Response Rate (ORR) (Phase 2), 2. Investigator-Assessed Progression-free survival (PFS) (Phase 2 and Phase 3), 3. Overall survival (Phase 3)

Secondary

MeasureTime frame
1. Overall survival (Phase 2), 2. PFS as determined by an independent review facility (IRF) (Phase 3), 3. PFS and OS in patients with PD L1 expression at TC ≥50% and TC ≥1% cut-off, as determined by central testing with Ventana PD-L1 (SP263) assay (Phase 3), 4. PFS at 6 months and 12 months (Phase 3), 5. OS rate at 12 months and 24 months (Phase 3), 6. Confirmed ORR (Phase 3), 7. Duration of response for patients with a confirmed objective response, defined as the time from first occurrence of a confirmed objective response to disease progression or death from any cause (whichever occurs first) (Phase 2 and Phase 3), 8. Time to confirmed deterioration (TTCD) in patient-reported physical functioning and global health status/quality of life (GHS/QoL), as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain,

Countries

Belgium, Denmark, France, Germany, Poland, Spain

Outcome results

None listed

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