A Study of Atezolizumab Compared With a Single-Agent Chemotherapy in Treatment Naïve Participants With Locally Advanced or Recurrent or Metastatic Non-Small Cell Lung Cancer Who Are Deemed Unsuitable For Platinum-Doublet Chemotherapy

Summary

This Phase III, global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody) compared with a single agent chemotherapy regimen by investigator choice (vinorelbine or gemcitabine) in treatment-naïve participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are deemed unsuitable for any platinum-doublet chemotherapy due to poor performance status (Eastern Cooperative Oncology Group \[ECOG\] performance status of 2-3).

Timeline

Start

2017-09-11

Primary completion

2022-04-30

Completion

2023-10-25

Publications

• Han B, Peters S, Le AT, Huang D, Wu G, Cao L, Pham CP, Zhao J, Wang K, Yang N, Zhong H, Hu Y, Morris S, Lam V, Graupner V, Gitlitz B, Hoglander E, Schulz C, Lee SM. First-line atezolizumab monotherapy vs . single-agent chemotherapy in patients with advanced or metastatic non-small cell lung cancer who are ineligible for platinum-based therapy: Analysis of the IPSOS Asian subpopulation. Chin Med J (Engl). 2026 Jun 20;139(12):1838-1845. doi: 10.1097/CM9.0000000000003796. Epub 2025 Dec 17.
• Peters S, Schulz C, Reck M, Prabhash K, Kowalski D, Szczesna A, Han B, Rittmeyer A, Talbot T, Vicente D, Califano R, Cortinovis D, Le AT, Huang D, Liu G, Cappuzzo F, Contreras JR, Palmero R, Mak MP, Popat S, Hu Y, Morris S, Srivastava MK, Kaul M, Graupner V, Gitlitz B, Lee SM. Brief Report: Post Hoc Validation of Platinum Ineligibility in NSCLC From the Phase III IPSOS Study. J Thorac Oncol. 2025 Dec;20(12):1843-1850. doi: 10.1016/j.jtho.2025.07.115. Epub 2025 Jul 22.
• Li B, Rong D, Lin H. Atezolizumab monotherapy as first-line treatment for non-small cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a cost-effectiveness analysis in the USA. BMJ Open. 2024 Nov 12;14(11):e083716. doi: 10.1136/bmjopen-2023-083716.
• Lee SM, Schulz C, Prabhash K, Kowalski D, Szczesna A, Han B, Rittmeyer A, Talbot T, Vicente D, Califano R, Cortinovis D, Le AT, Huang D, Liu G, Cappuzzo F, Reyes Contreras J, Reck M, Palmero R, Mak MP, Hu Y, Morris S, Hoglander E, Connors M, Biggane AM, Vollan HK, Peters S. First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study. Lancet. 2023 Aug 5;402(10400):451-463. doi: 10.1016/S0140-6736(23)00774-2. Epub 2023 Jul 6.
• Gijtenbeek RG, de Jong K, Venmans BJ, van Vollenhoven FH, Ten Brinke A, Van der Wekken AJ, van Geffen WH. Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status. Cochrane Database Syst Rev. 2023 Jul 7;7(7):CD013382. doi: 10.1002/14651858.CD013382.pub2.

Drugs

Indications