A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Summary
This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.
Timeline
- Start
- 2018-08-10
- Primary completion
- 2019-06-30
- Completion
- 2025-11-14
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo + Atezolizumab vs Tiragolumab + Atezolizumab; p = 0.0310; Odds Ratio (OR) 2.57 (95% CI 1.07 to 6.14); Cochran-Mantel-Haenszel NCT03563716 ↗
registry analysis (superiority test); Placebo + Atezolizumab vs Tiragolumab + Atezolizumab; p = 0.0153; Hazard Ratio (HR) 0.57 (95% CI 0.37 to 0.90); Log Rank NCT03563716 ↗
release “The randomised phase II Cityscape met both its primary endpoints of ORR and PFS in PD-L1-positive metastatic non-small cell lung cancer” roche.com ↗
Publications
- Guan X, Hu R, Choi Y, Srivats S, Nabet BY, Silva J, McGinnis L, Hendricks R, Nutsch K, Banta KL, Duong E, Dunkle A, Chang PS, Han CJ, Mittman S, Molden N, Daggumati P, Connolly W, Johnson M, Abreu DR, Cho BC, Italiano A, Gil-Bazo I, Felip E, Mellman I, Mariathasan S, Shames DS, Meng R, Chiang EY, Johnston RJ, Patil NS. Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells. Nature. 2024 Mar;627(8004):646-655. doi: 10.1038/s41586-024-07121-9. Epub 2024 Feb 28.
- Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792. doi: 10.1016/S1470-2045(22)00226-1. Epub 2022 May 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tiragolumab | Monoclonal antibody | 600 mg | Intravenous |
| Background | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |