{"commentary":{"count":111,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":46,"youtube":38,"podcast":25,"x_video":2},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05060016\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"DeLLphi-301","nct_id":"NCT05060016","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=dellphi-301-nct05060016. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"DeLLphi-301","arms":[{"description":"Participants will receive the low dose of Tarlatamab.","label":"Part 1: Tarlatamab Low Dose","type":"EXPERIMENTAL"},{"description":"Participants will receive the high dose of Tarlatamab.","label":"Part 1: Tarlatamab High Dose","type":"EXPERIMENTAL"},{"description":"Participants will receive the selected target dose of Tarlatamab based on findings in Part 1.","label":"Part 2: Dose Expansion","type":"EXPERIMENTAL"},{"description":"Participants will receive the selected target dose of Tarlatamab based on findings in Part 1 with reduced Cycle 1 monitoring requirements.","label":"Part 3: Modified Monitoring Substudy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-12-30","type":"ESTIMATED"},"conditions":["Relapsed/Refractory Small Cell Lung Cancer"],"enrollment":{"count":222,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Tarlatamab","type":"DRUG"}],"last_update":"2026-07-22","lead_sponsor":"Amgen","official_title":"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).","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2027-12-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Part 1 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Investigator","timeFrame":"Up to a maximum of 61 months"},{"measure":"Part 1 and Part 3 Only: Number of Participants who Experience One or More Treatment-emergent Adverse Events","timeFrame":"Up to a maximum of 61 months"},{"measure":"Part 1 Only: Serum Concentrations of Tarlatamab","timeFrame":"Up to a maximum of 24 months"},{"measure":"Part 1 and Part 2 Only: Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by Blinded Independent Central Review (BICR)","timeFrame":"Up to a maximum of 61 months"}],"references":[{"citation":"Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Bustamante Alvarez J, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L; DeLLphi-301 Investigators. Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 30;389(22):2063-2075. doi: 10.1056/NEJMoa2307980. Epub 2023 Oct 20.","pmid":"37861218","type":"BACKGROUND"},{"citation":"Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, Juan-Vidal O, Handzhiev S, Izumi H, Lee JS, Dziadziuszko R, Wolf J, Blackhall F, Reck M, Alvarez JB, Hummel HD, Dingemans AC, Sands J, Akamatsu H, Owonikoko TK, Ramalingam SS, Borghaei H, Johnson ML, Huang S, Mukherjee S, Minocha M, Jiang T, Martinez P, Anderson ES, Paz-Ares L. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer. Future Oncol. 2024 Dec;20(40):3355-3364. doi: 10.1080/14796694.2024.2402152. Epub 2024 Nov 12.","pmid":"39530627","type":"BACKGROUND"},{"citation":"Hummel HD, Ahn MJ, Blackhall F, Reck M, Akamatsu H, Ramalingam SS, Borghaei H, Johnson M, Dirnberger F, Cocks K, Huang S, Mukherjee S, Paz-Ares L. Patient-Reported Outcomes for Patients with Previously Treated Small Cell Lung Cancer Receiving Tarlatamab: Results from the DeLLphi-301 Phase 2 Trial. Adv Ther. 2025 Apr;42(4):1950-1964. doi: 10.1007/s12325-025-03136-4. Epub 2025 Mar 3.","pmid":"40025391","type":"BACKGROUND"},{"citation":"Kong S, Minocha M, Chen PW, Martinez P, Anderson ES, Parkes A, Houk BE, Lin CW. Population Pharmacokinetics of Tarlatamab, a Half-Life Extended DLL3-Directed Bispecific T-Cell Engager in Patients with Previously Treated Small Cell Lung Cancer. Clin Pharmacokinet. 2025 May;64(5):729-741. doi: 10.1007/s40262-025-01499-z. Epub 2025 Apr 22.","pmid":"40261494","type":"BACKGROUND"},{"citation":"Ahn MJ, Cho BC, Ohashi K, Izumi H, Lee JS, Han JY, Chiang CL, Huang S, Hamidi A, Mukherjee S, Xu KL, Akamatsu H. Asian Subgroup Analysis of Patients in the Phase 2 DeLLphi-301 Study of Tarlatamab for Previously Treated Small Cell Lung Cancer. Oncol Ther. 2025 Dec;13(4):1041-1054. doi: 10.1007/s40487-025-00372-0. Epub 2025 Sep 4.","pmid":"40908346","type":"BACKGROUND"},{"citation":"Chen PW, Minocha M, Kong S, Jiang T, Anderson ES, Parkes A, Martinez P, Houk BE, Lin CW. Tarlatamab Exposure-Efficacy and Exposure-Safety Relationships to Inform Dose Selection in Patients with Small Cell Lung Cancer. Clin Cancer Res. 2025 Nov 14;31(22):4688-4697. doi: 10.1158/1078-0432.CCR-25-2134.","pmid":"40928991","type":"BACKGROUND"},{"citation":"Dirnberger F, Wang J, King-Kallimanis B, Cocks K, Skingley G, Clarke N, Huang S, Mukherjee S, Koller M. Derivation of Meaningful Change Thresholds for European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-LC13 in Patients With Small-Cell Lung Cancer. Value Health. 2026 Feb;29(2):223-232. doi: 10.1016/j.jval.2025.09.011. Epub 2025 Sep 25.","pmid":"41015335","type":"BACKGROUND"}],"start_date":{"date":"2021-12-01","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC)","url":"https://clinicaltrials.gov/study/NCT05060016"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/dellphi-301-nct05060016"}