{"entity":{"id":"dellphi-304","kind":"trial","name":"DeLLphi-304","aka":["dellphi-304"],"tldr":"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.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT05740566","url":"https://clinicaltrials.gov/study/NCT05740566"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":["dll3"],"drugs":["tarlatamab","amrubicin"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["luis-paz-ares","charles-rudin"],"bottlenecks":[],"keyPapers":["paper-dellphi-301-nejm-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05740566","phase":"3","setting":"Second-line small-cell lung cancer: tarlatamab vs chemotherapy","sponsor":"Amgen","result":"OS HR 0.60.","started":"2023-05-31","startedType":"actual","yearReported":2025,"enrolled":509,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Tarlatamab","n":254,"value":13.6},{"name":"Chemotherapy (topotecan, lurbinectedin, or amrubicin)","n":255,"value":8.3}],"hr":0.6,"ci":[0.47,0.77],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT05740566"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Tarlatamab","value":4.2},{"name":"Chemotherapy","value":3.7}],"hr":0.71,"ci":[0.59,0.86],"source":"https://clinicaltrials.gov/study/NCT05740566"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Tarlatamab","value":35},{"name":"Chemotherapy","value":20}],"source":"https://doi.org/10.1056/NEJMoa2502099"}],"replication":"Confirms the single-arm DeLLphi-301 result (ORR 40%) that supported accelerated approval; first-line data (DeLLphi-305) pending."},"route":"/trials/dellphi-304/","neighbours":{"cancer":[{"id":"extensive-stage-sclc","kind":"cancer","name":"Extensive-stage small-cell lung cancer","route":"/cancers/extensive-stage-sclc/"},{"id":"limited-stage-sclc","kind":"cancer","name":"Limited-stage small-cell lung cancer","route":"/cancers/limited-stage-sclc/"},{"id":"lung-cancer","kind":"cancer","name":"Lung cancer (all types)","route":"/cancers/lung-cancer/"},{"id":"sclc","kind":"cancer","name":"Small-cell lung cancer","route":"/cancers/sclc/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"dll3","kind":"target","name":"DLL3","route":"/targets/dll3/"}],"drug":[{"id":"amrubicin","kind":"drug","name":"Amrubicin","route":"/drugs/amrubicin/"},{"id":"tarlatamab","kind":"drug","name":"Tarlatamab","route":"/drugs/tarlatamab/"},{"id":"topotecan","kind":"drug","name":"Topotecan","route":"/drugs/topotecan/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"}],"person":[{"id":"charles-rudin","kind":"person","name":"Charles M. Rudin","route":"/people/charles-rudin/"},{"id":"luis-paz-ares","kind":"person","name":"Luis Paz-Ares","route":"/people/luis-paz-ares/"}],"paper":[{"id":"paper-dellphi-301-nejm-2023","kind":"paper","name":"DeLLphi-301: tarlatamab, a DLL3-targeting T-cell engager, in previously treated small-cell lung cancer","route":"/key-papers/paper-dellphi-301-nejm-2023/"},{"id":"paper-tarlatamab-sclc-n-engl-j-med-2025","kind":"paper","name":"Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy","route":"/key-papers/paper-tarlatamab-sclc-n-engl-j-med-2025/"}],"trial":[{"id":"nct05060016","kind":"trial","name":"A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)","route":"/trials/nct05060016/"}]}}