Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

Summary

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Timeline

Start

2017-06-01

Primary completion

2021-03-12

Completion

2027-11-15

Publications

• Peters S, Cho BC, Luft AV, Alatorre-Alexander J, Geater SL, Laktionov K, Trukhin D, Kim SW, Ursol GM, Hussein M, Lim FL, Yang CT, Araujo LH, Saito H, Reinmuth N, Lowery C, Mann H, Stewart R, Jiang H, Garon EB, Mok T, Johnson ML. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy in First-Line Metastatic NSCLC: Five-Year Overall Survival Outcomes From the Phase 3 POSEIDON Trial. J Thorac Oncol. 2025 Jan;20(1):76-93. doi: 10.1016/j.jtho.2024.09.1381. Epub 2024 Sep 5.
• He JZ, Duval V, Jauslin P, Goncalves A, Abegesah A, Fan C, Lim K, Song X, Chen C, Shi X, Mann H, Krug L, Ren S, Phipps A, Gibbs M, Zhou D. Population Pharmacokinetics and Exposure-Response Analysis for the CTLA-4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study. Clin Pharmacol Ther. 2023 Dec;114(6):1375-1386. doi: 10.1002/cpt.3063. Epub 2023 Oct 17.
• Johnson ML, Cho BC, Luft A, Alatorre-Alexander J, Geater SL, Laktionov K, Kim SW, Ursol G, Hussein M, Lim FL, Yang CT, Araujo LH, Saito H, Reinmuth N, Shi X, Poole L, Peters S, Garon EB, Mok T; POSEIDON investigators. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study. J Clin Oncol. 2023 Feb 20;41(6):1213-1227. doi: 10.1200/JCO.22.00975. Epub 2022 Nov 3.

Drugs

Indications