M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)

Summary

The purpose of the study is to evaluate the efficacy and safety of bintrafusp alfa (M7824) compared with pembrolizumab in participants with advanced NSCLC with high PD-L1-tumor expression, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. The Phase III adaptive design allows for the option to recruit up to 584 patients based on pre-specified rules.

Timeline

Start

2018-10-01

Primary completion

2021-06-07

Completion

2024-06-25

Publications

• Results Brown T, Pilkington G, Bagust A, Boland A, Oyee J, Tudur-Smith C, Blundell M, Lai M, Martin Saborido C, Greenhalgh J, Dundar Y, Dickson R. Clinical effectiveness and cost-effectiveness of first-line chemotherapy for adult patients with locally advanced or metastatic non-small cell lung cancer: a systematic review and economic evaluation. Health Technol Assess. 2013 Jul;17(31):1-278. doi: 10.3310/hta17310.
• Results Cho BC, Lee JS, Wu YL, Cicin I, Dols MC, Ahn MJ, Cuppens K, Veillon R, Nadal E, Dias JM, Martin C, Reck M, Garon EB, Felip E, Paz-Ares L, Mornex F, Vokes EE, Adjei AA, Robinson C, Sato M, Vugmeyster Y, Machl A, Audhuy F, Chaudhary S, Barlesi F. Bintrafusp Alfa Versus Pembrolizumab in Patients With Treatment-Naive, Programmed Death-Ligand 1-High Advanced NSCLC: A Randomized, Open-Label, Phase 3 Trial. J Thorac Oncol. 2023 Dec;18(12):1731-1742. doi: 10.1016/j.jtho.2023.08.018. Epub 2023 Aug 18.
• Milenkovic-Grisic AM, Terranova N, Mould DR, Vugmeyster Y, Mrowiec T, Machl A, Girard P, Venkatakrishnan K, Khandelwal A. Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non-small cell lung cancer based on bintrafusp alfa trials. CPT Pharmacometrics Syst Pharmacol. 2024 Jan;13(1):143-153. doi: 10.1002/psp4.13068. Epub 2023 Dec 13.

Drugs

Indications