# DeLLphi-304

Source: https://onco.cc/trials/dellphi-304/  
OnCo record `dellphi-304` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

DeLLphi-304 was the first trial in which a T-cell engager improved survival in a common solid tumour.

## Summary

DeLLphi-304, trial NCT05740566 sponsored by Amgen and presented at the ASCO 2025 plenary and in the New England Journal of Medicine, was the first trial in which a T-cell engager improved survival in a common solid tumour, second-line small-cell lung cancer. It randomised 509 patients to the DLL3 engager tarlatamab or chemotherapy with topotecan, lurbinectedin or amrubicin, met its primary overall survival endpoint with a large effect, and improved progression-free survival and response rate. OnCo links it to small-cell lung cancer, DLL3 as a target, tarlatamab, topotecan, Luis Paz-Ares, Charles M. Rudin and the DeLLphi-301 paper, and it confirms the single-arm DeLLphi-301 result that supported accelerated approval. First-line data from DeLLphi-305 are pending, and whether tarlatamab belongs in maintenance rather than at relapse is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Also known as: dellphi-304
- Registry id: NCT05740566
- Phase: 3
- Setting: Second-line small-cell lung cancer: tarlatamab vs chemotherapy
- Sponsor: Amgen
- Enrolled: 509
- Result: OS HR 0.60.
- Outcomes: Overall survival: Tarlatamab 13.6 months vs Chemotherapy (topotecan, lurbinectedin, or amrubicin) 8.3 months, HR 0.6; Progression-free survival: Tarlatamab 4.2 months vs Chemotherapy 3.7 months, HR 0.71; Objective response rate: Tarlatamab 35% vs Chemotherapy 20%
- Replication: Confirms the single-arm DeLLphi-301 result (ORR 40%) that supported accelerated approval; first-line data (DeLLphi-305) pending.

## Sources

- ClinicalTrials.gov NCT05740566: https://clinicaltrials.gov/study/NCT05740566

## Connected records

- cancers: [Extensive-stage small-cell lung cancer](https://onco.cc/cancers/extensive-stage-sclc/), [Limited-stage small-cell lung cancer](https://onco.cc/cancers/limited-stage-sclc/), [Lung cancer (all types)](https://onco.cc/cancers/lung-cancer/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- technologies: [T-cell engagers (bispecific)](https://onco.cc/technologies/t-cell-engager/)
- targets: [DLL3](https://onco.cc/targets/dll3/)
- drugs: [Amrubicin](https://onco.cc/drugs/amrubicin/), [Tarlatamab](https://onco.cc/drugs/tarlatamab/), [Topotecan](https://onco.cc/drugs/topotecan/)
- companies: [Amgen](https://onco.cc/companies/amgen/)
- people: [Charles M. Rudin](https://onco.cc/people/charles-rudin/), [Luis Paz-Ares](https://onco.cc/people/luis-paz-ares/)
- key papers: [DeLLphi-301: tarlatamab, a DLL3-targeting T-cell engager, in previously treated small-cell lung cancer](https://onco.cc/key-papers/paper-dellphi-301-nejm-2023/), [Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy](https://onco.cc/key-papers/paper-tarlatamab-sclc-n-engl-j-med-2025/)
- trials: [A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)](https://onco.cc/trials/nct05060016/)

---
JSON: https://onco.cc/api/v1/entities/dellphi-304.json