Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

Summary

The primary objectives of this study are: Part 1: To compare the overall survival (OS) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus platinum-based doublet chemotherapy in the first-line treatment of patients with advanced squamous or nonsquamous non-small cell lung cancer (NSCLC) with tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the OS of cemiplimab/chemo-f with placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression. The key secondary objectives are: Part 1: To compare the progression-free survival (PFS) and objective response rate (ORR) of cemiplimab/chemo-f and cemiplimab/chemo-l/ipi versus chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC and tumors expressing PD-L1 in \<50% of tumor cells. Part 2: To compare the PFS and ORR of cemiplimab/chemo-f versus placebo/chemo-f in the first-line treatment of patients with advanced squamous or non-squamous NSCLC irrespective of PD-L1 expression.

Timeline

Start

2018-03-06

Primary completion

2025-02-27

Completion

2025-02-27

Publications

• Baramidze A, Makharadze T, Gogishvili M, Melkadze T, Giorgadze D, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Ag McIntyre D, Perez J, Kaul M, Quek RGW, Seebach F, Rietschel P, Pouliot JF. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer with PD-L1 >/= 1 %: A subgroup analysis from the EMPOWER-Lung 3 part 2 trial. Lung Cancer. 2024 Jul;193:107821. doi: 10.1016/j.lungcan.2024.107821. Epub 2024 May 13.
• Zhao B, Qi H, Wu J, Ma W. Cemiplimab Plus Chemotherapy Could Be a First-Line Option for Advanced and Metastatic NSCLC: Results From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. J Thorac Oncol. 2023 Jul;18(7):e72-e73. doi: 10.1016/j.jtho.2023.04.001. No abstract available.
• Makharadze T, Gogishvili M, Melkadze T, Baramidze A, Giorgadze D, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Li S, Li Y, Kaul M, Quek RGW, Pouliot JF, Seebach F, Lowy I, Gullo G, Rietschel P. Cemiplimab Plus Chemotherapy Versus Chemotherapy Alone in Advanced NSCLC: 2-Year Follow-Up From the Phase 3 EMPOWER-Lung 3 Part 2 Trial. J Thorac Oncol. 2023 Jun;18(6):755-768. doi: 10.1016/j.jtho.2023.03.008. Epub 2023 Mar 29.
• Gogishvili M, Melkadze T, Makharadze T, Giorgadze D, Dvorkin M, Penkov K, Laktionov K, Nemsadze G, Nechaeva M, Rozhkova I, Kalinka E, Gessner C, Moreno-Jaime B, Passalacqua R, Li S, McGuire K, Kaul M, Paccaly A, Quek RGW, Gao B, Seebach F, Weinreich DM, Yancopoulos GD, Lowy I, Gullo G, Rietschel P. Cemiplimab plus chemotherapy versus chemotherapy alone in non-small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. Nat Med. 2022 Nov;28(11):2374-2380. doi: 10.1038/s41591-022-01977-y. Epub 2022 Aug 25.

Drugs

Indications