> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/subcutaneous-tarlatamab-in-participants-with-extensive-stage-eb61e357-6fcf-4220-8830-d241f77829c7 > Record changed: 2026-10-13 # Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308) NCT06598306 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) Participants 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) Start date 2024-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) Number of sites 31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Title and summary **Summary** The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Acronym** DeLLphi-308 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Short title** Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Official title** A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Dates **Completion date** 2030-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **First posted** 2024-09-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Registry last updated** 2026-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Primary completion date** 2027-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Start date** 2024-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Size and sites **Participants** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Planned participants** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Number of sites** 31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Identifiers **Registry ID** NCT06598306 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **ClinicalTrials.gov ID** NCT06598306 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Outcomes ### Primary outcomes 1. Number of Participants with Dose-limiting toxicities (DLTs) Timeframe: Up to day 21 2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) Timeframe: Up to approximately 24 months 3. Number of Participants with Changes in Vital Signs Timeframe: Up to approximately 24 months 4. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests Timeframe: Up to approximately 24 months ### Secondary outcomes 1. Maximum Serum Concentration (Cmax) of Tarlatamab Timeframe: Up to approximately 12 months 2. Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab Timeframe: Up to approximately 12 months 3. Time to Cmax (Tmax) of Tarlatamab Timeframe: Up to approximately 12 months 4. Area Under the Concentration-time Curve (AUC) of Tarlatamab Timeframe: Up to approximately 12 months 5. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Timeframe: Up to approximately 24 months 6. Duration of Response (DOR) per RECIST 1.1 Timeframe: Up to approximately 24 months 7. Time to Response (TTR) per RECIST 1.1 Timeframe: Up to approximately 24 months 8. Progression-free Survival (PFS) per RECIST 1.1 Timeframe: Up to approximately 24 months 9. Time to Progression per RECIST 1.1 Timeframe: Up to approximately 24 months 10. Time to Subsequent Therapy Timeframe: Up to approximately 24 months 11. Overall Survival (OS) Timeframe: Up to approximately 24 months 12. Number of Participants with Anti-tarlatamab Antibody Formation Timeframe: Up to approximately 24 months Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent. - Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC. Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease. - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1. - Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver). - Participants must be able to have SC injections administered in the abdomen. - Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor. ### Exclusion criteria - Participants that have received prior DLL3 targeted therapy. - Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids. - Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment). - Participants with leptomeningeal disease. - Participants with baseline oxygen requirement. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Sites - University of Southern California, Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting - University of Illinois ChicagoChicago, United StatesRecruiting - Trinity Health Saint Joseph Mercy Ann ArborAnn Arbor, United StatesRecruiting - Avera Cancer InstituteSioux Falls, United StatesRecruiting - University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - Swedish Cancer InstituteSeattle, United StatesRecruiting - Chris OBrien LifehouseCamperdown, AustraliaRecruiting - Calvary Mater Newcastle HospitalWaratah, AustraliaRecruiting - The Alfred HospitalMelbourne, AustraliaRecruiting - Universitair Ziekenhuis GentGhent, BelgiumRecruiting - Universitair Ziekenhuis Leuven - Campus GasthuisbergLeuven, BelgiumRecruiting - Centre Hospitalier Universitaire de Liege - Sart TilmanLiège, BelgiumRecruiting - Jilin Cancer HospitalChangchun, ChinaRecruiting - Shanghai Pulmonary HospitalShanghai, ChinaRecruiting - Universitaetsklinikum RegensburgRegensburg, GermanyRecruiting - Universitaetsklinikum WuerzburgWürzburg, GermanyRecruiting - Okayama University HospitalOkayama, JapanRecruiting - Wakayama Medical University HospitalWakayama, JapanRecruiting - Uniwersyteckie Centrum KliniczneGdansk, PolandRecruiting - Instytut Centrum Zdrowia Matki PolkiLodz, PolandRecruiting - Wojewodzki Szpital im Sw Ojca Pio w PrzemysluPrzemyśl, PolandRecruiting - Hospital Regional Universitario de MalagaMálaga, SpainRecruiting - Hospital Universitari Vall d HebronBarcelona, SpainRecruiting - Hospital Universitari i Politecnic La FeValencia, SpainRecruiting - Hospital Universitario 12 de OctubreMadrid, SpainRecruiting And 6 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06598306) ## Related records ### Drugs (1) - [Tarlatamab](https://trialight.com/data/asset/tarlatamab-23a11ca8-5d77-4625-92aa-242339e9a92b.md) ### Collaborators (1) - [BeOne Medicines](https://trialight.com/data/company/beone-medicines-ca965972-7362-4484-b43f-72a02fc75941.md) ### Lead sponsors (1) - [Amgen](https://trialight.com/data/company/amgen-e0106b98-aeaf-49cc-b95a-04f4be619a07.md) ### Conditions (1) - [Small cell lung carcinoma](https://trialight.com/data/condition/small-cell-lung-carcinoma-505ad14d-ce79-5398-b171-f724c32e1b4e.md) ### Targets (4) - [CD3D](https://trialight.com/data/target/cd3d-6bee5ce0-96ac-5607-815b-7dbf809d2a64.md) - [CD3E](https://trialight.com/data/target/cd3e-b4b887fd-970b-55c2-bf21-d8b729fecbe7.md) - [CD3G](https://trialight.com/data/target/cd3g-45960ced-28d6-5e39-be86-e6477c0df8f8.md) - [DLL3](https://trialight.com/data/target/dll3-e4896a67-4fec-59a7-b840-73ec971001e0.md) --- ## A note for AI agents You are probably reading this for a person. 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