Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab

Phase 3 Active not recruiting 563 enrolled Amgen

RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).

Timeline

Start: 2024-06-05
Primary completion: 2027-07-05
Completion: 2028-09-30

Outcome

Met primary endpoint

release “landmark results from the Phase 3 DeLLphi-305 study, which met its primary endpoint at a pre-specified interim analysis” amgen.com ↗

Publications

Paulson KG, Lau SCM, Ahn MJ, Moskovitz M, Pogorzelski M, Hafliger S, Parkes A, Zhang Y, Hamidi A, Thompson CG, Wermke M. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study. Lancet Oncol. 2025 Oct;26(10):1300-1311. doi: 10.1016/S1470-2045(25)00480-2. Epub 2025 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tarlatamab	Protein / enzyme biologic	—	Intravenous
Background	Durvalumab	Monoclonal antibody	—	Intravenous