{"entity":{"id":"dellphi-305","kind":"trial","name":"DeLLphi-305","aka":[],"tldr":"Tests whether adding the DLL3 T-cell engager to first-line maintenance can push median survival in extensive-stage disease past two years, as the phase 1b hinted.","summary":"Builds on DeLLphi-303 (phase 1b), where tarlatamab plus a PD-L1 inhibitor as first-line maintenance gave median OS 25.3 months and PFS 5.6 months. On 8 September 2026 Amgen and AstraZeneca announced that the trial met its primary overall survival endpoint at the pre-specified interim analysis, with statistically significant gains in progression-free survival and response rate; detailed figures are held for a congress presentation. A parallel phase 3 (DeLLphi-312) adds tarlatamab to induction chemo-immunotherapy.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT06211036","url":"https://clinicaltrials.gov/study/NCT06211036"},{"label":"Amgen topline release (8 Sep 2026)","url":"https://www.amgen.com/newsroom/press-releases/2026/09/imdelltra-in-combination-with-imfinzi-demonstrated-landmark-improvement-in-overall-survival-in-first-line-extensive-stage-small-cell-lung-cancer"},{"label":"DeLLphi-303 results (IASLC)","url":"https://www.iaslc.org/iaslc-news/press-release/tarlatamab-anti-pd-l1-first-line-maintenance-after-chemo-immunotherapy-es"}],"tags":[],"related":[],"cancers":["sclc","extensive-stage-sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":["dll3"],"drugs":["tarlatamab","durvalumab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06211036","phase":"3","setting":"First-line maintenance in ES-SCLC after platinum-etoposide-durvalumab: tarlatamab + durvalumab vs durvalumab","sponsor":"Amgen","result":"Met the primary overall survival endpoint at the pre-specified interim analysis (Amgen, 8 September 2026); progression-free survival and response rate also improved; figures not yet disclosed.","started":"2024-06-05","startedType":"actual","yearReported":2026,"enrolled":563,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival","primary":true,"unit":"months","arms":[{"name":"Tarlatamab + durvalumab maintenance","note":"Met at the pre-specified interim analysis: Amgen's 8 September 2026 release describes a statistically significant and clinically meaningful improvement; medians and hazard ratio not yet disclosed, detailed data promised for an upcoming congress"},{"name":"Durvalumab maintenance"}],"source":"https://www.amgen.com/newsroom/press-releases/2026/09/imdelltra-in-combination-with-imfinzi-demonstrated-landmark-improvement-in-overall-survival-in-first-line-extensive-stage-small-cell-lung-cancer"},{"endpoint":"Progression-free survival","unit":"months","arms":[{"name":"Tarlatamab + durvalumab maintenance","note":"Statistically significant and clinically meaningful improvement per the sponsor; figures not yet public"},{"name":"Durvalumab maintenance"}],"source":"https://www.amgen.com/newsroom/press-releases/2026/09/imdelltra-in-combination-with-imfinzi-demonstrated-landmark-improvement-in-overall-survival-in-first-line-extensive-stage-small-cell-lung-cancer"},{"endpoint":"Objective response rate","unit":"%","arms":[{"name":"Tarlatamab + durvalumab maintenance","note":"Statistically significant improvement per the sponsor; figures not yet public"},{"name":"Durvalumab maintenance"}],"source":"https://www.amgen.com/newsroom/press-releases/2026/09/imdelltra-in-combination-with-imfinzi-demonstrated-landmark-improvement-in-overall-survival-in-first-line-extensive-stage-small-cell-lung-cancer"}],"replication":"First phase 3 of a DLL3 T-cell engager in first-line maintenance; consistent in direction with the DeLLphi-303 phase 1b cohort (median OS 25.3 months). DeLLphi-312 (tarlatamab added to induction chemo-immunotherapy) is the confirmatory sibling."},"route":"/trials/dellphi-305/","neighbours":{"cancer":[{"id":"extensive-stage-sclc","kind":"cancer","name":"Extensive-stage small-cell lung cancer","route":"/cancers/extensive-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":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"tarlatamab","kind":"drug","name":"Tarlatamab","route":"/drugs/tarlatamab/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"}],"pairing":[{"id":"chemo-io-then-maintenance-sclc","kind":"pairing","name":"Chemo-immunotherapy induction → maintenance intensification (SCLC)","route":"/pairings/chemo-io-then-maintenance-sclc/"}],"trial":[{"id":"nct05060016","kind":"trial","name":"A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)","route":"/trials/nct05060016/"}]}}