{"preliminary_commentary":{"by_channel":{"x_thread":17,"youtube":8,"podcast":5},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT03319940\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"name":"DeLLphi-300","nct_id":"NCT03319940","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=dellphi-300-nct03319940. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming 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: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Tarlatamab monotherapy","label":"Part A","type":"EXPERIMENTAL"},{"description":"Tarlatamab with Pembrolizumab","label":"Part C","type":"EXPERIMENTAL"},{"description":"Tarlatamab with additional CRS mitigation strategies","label":"Part D","type":"EXPERIMENTAL"},{"description":"Tarlatamab administration with 24-hour monitoring","label":"Part E","type":"EXPERIMENTAL"},{"description":"Tarlatamab administered in outpatient infusion centers with 8-hour monitoring\n\nOptional wearable digital device substudy (US sites only)","label":"Part F","type":"EXPERIMENTAL"},{"description":"Tarlatamab additional dosing schedule\n\nOptional wearable digital device substudy (US sites only)","label":"Part G","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-12-31","type":"ESTIMATED"},"conditions":["Small Cell Lung Carcinoma"],"enrollment":{"count":269,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Tarlatamab","otherNames":[],"type":"DRUG"},{"name":"Pembrolizumab","otherNames":[],"type":"DRUG"},{"name":"CRS Mitigation Strategies","otherNames":[],"type":"DRUG"}],"last_update":"2025-11-19","lead_sponsor":"Amgen","official_title":"A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2026-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Number of participants with dose limiting toxicities (DLT) for all indications","timeFrame":"6 months"},{"measure":"Number of participants with treatment-emergent adverse events (AEs) for all indications","timeFrame":"4 years"},{"measure":"Number of participants with treatment-related AEs for all indications","timeFrame":"4 years"},{"measure":"Number of participants with clinically significant changes in vital signs for all indications","timeFrame":"4 years"},{"measure":"Number of participants with significant changes in electrocardiogram (ECG) for all indications","timeFrame":"4 years"},{"measure":"Number of participants with significant changes in physical examinations for all indications","timeFrame":"4 years"},{"measure":"Number of participants with significant changes in clinical laboratory tests for all indications","timeFrame":"4 years"}],"references":[{"citation":"Owen DH, Giffin MJ, Bailis JM, Smit MD, Carbone DP, He K. DLL3: an emerging target in small cell lung cancer. J Hematol Oncol. 2019 Jun 18;12(1):61. doi: 10.1186/s13045-019-0745-2.","pmid":"31215500","type":"BACKGROUND"},{"citation":"Dowlati A, Hummel HD, Champiat S, Olmedo ME, Boyer M, He K, Steeghs N, Izumi H, Johnson ML, Yoshida T, Bouchaab H, Borghaei H, Felip E, Jost PJ, Gadgeel S, Chen X, Yu Y, Martinez P, Parkes A, Paz-Ares L. Sustained Clinical Benefit and Intracranial Activity of Tarlatamab in Previously Treated Small Cell Lung Cancer: DeLLphi-300 Trial Update. J Clin Oncol. 2024 Oct 10;42(29):3392-3399. doi: 10.1200/JCO.24.00553. Epub 2024 Aug 29.","pmid":"39208379","type":"BACKGROUND"},{"citation":"Paz-Ares L, Champiat S, Lai WV, Izumi H, Govindan R, Boyer M, Hummel HD, Borghaei H, Johnson ML, Steeghs N, Blackhall F, Dowlati A, Reguart N, Yoshida T, He K, Gadgeel SM, Felip E, Zhang Y, Pati A, Minocha M, Mukherjee S, Goldrick A, Nagorsen D, Hashemi Sadraei N, Owonikoko TK. Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study. J Clin Oncol. 2023 Jun 1;41(16):2893-2903. doi: 10.1200/JCO.22.02823. Epub 2023 Jan 23.","pmid":"36689692","type":"BACKGROUND"},{"citation":"Chiang AC, Olmedo Garcia ME, Carlisle JW, Dowlati A, Reguart N, Felip E, Jost PJ, Steeghs N, Stec R, Gadgeel SM, Loong HH, Jiang W, Hamidi A, Parkes A, Paz-Ares L. Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy. ESMO Open. 2025 Apr;10(4):104538. doi: 10.1016/j.esmoop.2025.104538. 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