{"entity":{"id":"nct05060016","kind":"trial","name":"A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)","aka":["DeLLphi-301"],"tldr":"A phase 2 trial of Tarlatamab in small-cell lung cancer, run by Amgen, active and no longer recruiting.","summary":"A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) is a phase 2 interventional study registered as NCT05060016 by Amgen, with 222 participants enrolled, started 2021-12-01 and due to reach its primary completion in 2027-12-30. Interventions recorded: Tarlatamab. Conditions listed: Relapsed/Refractory Small Cell Lung Cancer. No results are recorded here; the registry entry is the source.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05060016","url":"https://clinicaltrials.gov/study/NCT05060016"},{"label":"DeLLphi-301 (New England Journal of Medicine 2023)","url":"https://doi.org/10.1056/NEJMoa2307980"},{"label":"NICE TA1091: tarlatamab for extensive-stage small-cell lung cancer after 2 or more treatments (not recommended)","url":"https://www.nice.org.uk/guidance/ta1091"}],"tags":["ctgov-ingest"],"related":[],"cancers":["sclc"],"sections":[],"technologies":["t-cell-engager"],"targets":[],"drugs":["tarlatamab"],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":["dellphi-304","dellphi-305","lurbinectedin-basket-sclc"],"people":[],"bottlenecks":[],"keyPapers":["paper-dellphi-301-nejm-2023"],"journals":[],"dependsOn":[],"notes":["Tarlatamab is a bispecific T-cell engager binding delta-like ligand 3 on small-cell lung cancer and CD3 on T cells. In this phase 2 trial, 220 patients who had had a median of two previous lines received tarlatamab 10 mg or 100 mg intravenously every two weeks. Objective response by blinded independent central review was 40 percent (97.5 percent confidence interval 29 to 52) at 10 mg and 32 percent (21 to 44) at 100 mg; response lasted at least six months in 59 percent (40 of 68) and was ongoing at cutoff in 55 and 57 percent of responders. Median progression-free survival was 4.9 months (95 percent confidence interval 2.9 to 6.7) at 10 mg and 3.9 months at 100 mg. Cytokine release syndrome occurred in 51 percent at 10 mg and 61 percent at 100 mg, with immune effector cell-associated neurotoxicity syndrome in a minority; 3 percent discontinued for a related event (New England Journal of Medicine 2023). The FDA granted accelerated approval on 16 May 2024 and traditional approval on 19 November 2025. NICE TA1091 (20 August 2025) does not recommend tarlatamab in England."],"nct":"NCT05060016","phase":"2","setting":"A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-301).","sponsor":"Amgen","result":"Objective response 40 percent at the 10 mg dose and 32 percent at 100 mg in previously treated small-cell lung cancer; median progression-free survival 4.9 and 3.9 months.","started":"2021-12-01","startedType":"actual","yearReported":2023,"enrolled":222,"enrolledBasis":"registry","outcomes":[],"replication":"DeLLphi-304 confirmed the benefit against chemotherapy in the second line."},"route":"/trials/nct05060016/","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/"}],"drug":[{"id":"tarlatamab","kind":"drug","name":"Tarlatamab","route":"/drugs/tarlatamab/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"}],"trial":[{"id":"dellphi-304","kind":"trial","name":"DeLLphi-304","route":"/trials/dellphi-304/"},{"id":"dellphi-305","kind":"trial","name":"DeLLphi-305","route":"/trials/dellphi-305/"},{"id":"lurbinectedin-basket-sclc","kind":"trial","name":"Lurbinectedin basket trial, small-cell lung cancer cohort","route":"/trials/lurbinectedin-basket-sclc/"}],"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/"}]}}