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DeLLphi-304 was the first trial in which a T-cell engager improved survival in a common solid tumour.
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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
509 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survivalprimary | Tarlatamab | 254 | 13.6 months | 0.6 (0.47 to 0.77) | <0.001 | link |
| Chemotherapy (topotecan, lurbinectedin, or amrubicin) | 255 | 8.3 months | ||||
| Progression-free survival | Tarlatamab | - | 4.2 months | 0.71 (0.59 to 0.86) | - | link |
| Chemotherapy | - | 3.7 months | ||||
| Objective response rate | Tarlatamab | - | 35% | - | - | link |
| Chemotherapy | - | 20% |
One of the most cited trial reports Europe PMC returns for Tarlatamab in Small-cell lung cancer, so it is a natural first reading for anyone weighing the idea it is linked from. The record was linked automatically by title and abstract; read the abstract above and the paper itself before relying on any figure.
Patients with small-cell lung cancer that has relapsed after chemotherapy now have a drug that works far better than topotecan or lurbinectedin, and it is the first T-cell engager approved for a solid tumour. Treatment requires inpatient monitoring for the first doses because of cytokine release syndrome, which most centres now manage on a short-stay basis. It does not yet apply to first-line treatment, where trials are ongoing.
Shares A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC), DLL3, Tarlatamab, Amgen.
Shares Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy, DeLLphi-301: tarlatamab, a DLL3-targeting T-cell engager, in previously treated small-cell lung cancer, DLL3, Tarlatamab.
Shares Tarlatamab, Limited-stage small-cell lung cancer, Amgen, T-cell engagers (bispecific).
Shares Tarlatamab, Amgen, Extensive-stage small-cell lung cancer, T-cell engagers (bispecific).
Shares Tarlatamab, Amgen, T-cell engagers (bispecific), Small-cell lung cancer.
Shares Tarlatamab, Amgen, T-cell engagers (bispecific), Small-cell lung cancer.
Shares Amrubicin, Topotecan, Extensive-stage small-cell lung cancer, Small-cell lung cancer.
Shares DeLLphi-301: tarlatamab, a DLL3-targeting T-cell engager, in previously treated small-cell lung cancer, DLL3, Limited-stage small-cell lung cancer, Extensive-stage small-cell lung cancer.