drugset / Trial / NCT05740566
Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).
Timeline
- Start
- 2023-05-31
- Primary completion
- 2025-01-29
- Completion
- 2028-03-26
Outcome
Met primary endpoint
registry analysis (superiority test); Standard of Care (SOC) vs Tarlatamab 1 mg to 10 mg Q2W; p <0.001; Hazard Ratio (HR) 0.599 (95% CI 0.468 to 0.768) NCT05740566 ↗
release “The global Phase 3 DeLLphi-304 study met its primary endpoint” amgen.com ↗
Publications
- Background Mountzios G, Sun L, Cho BC, Demirci U, Baka S, Gumus M, Lugini A, Zhu B, Yu Y, Korantzis I, Han JY, Ciuleanu TE, Ahn MJ, Rocha P, Mazieres J, Lau SCM, Schuler M, Blackhall F, Yoshida T, Owonikoko TK, Paz-Ares L, Jiang T, Hamidi A, Gauto D, Recondo G, Rudin CM; DeLLphi-304 Investigators. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy. N Engl J Med. 2025 Jul 24;393(4):349-361. doi: 10.1056/NEJMoa2502099. Epub 2025 Jun 2.
- Dirnberger F, Patel S, Boyne DJ, Lan Z, Uyei J, Wang J, Cho S, DeCosta L, Bridges IM, Tapan U. Matching-Adjusted Indirect Comparison of Tarlatamab for Patients with Platinum-Refractory or Platinum-Resistant Extensive-Stage Small-Cell Lung Cancer. Adv Ther. 2026 Jun 30. doi: 10.1007/s12325-026-03659-4. Online ahead of print.
- Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Alvarez JB, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer. Future Oncol. 2024 Dec;20(40):3355-3364. doi: 10.1080/14796694.2024.2402152. Epub 2024 Nov 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amrubicin | Small molecule | — | — |
| Comparator | Lurbinectedin | Other / unclassified | — | — |
| Subject | Tarlatamab | Protein / enzyme biologic | — | Intravenous |
| Comparator | Topotecan | Small molecule | — | — |