> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-tarlatamab-zl-1310-anti-programmed-death-ligand-1-3f24336d-d040-47f9-a183-b1ae86c75510 > Record changed: 2026-10-13 # Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) NCT07531095 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) Lead sponsor Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) Start date 2026-04-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) Number of sites 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Title and summary **Summary** The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Acronym** DeLLphi-313 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Short title** Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Official title** A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Dates **Completion date** 2031-05-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **First posted** 2026-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Registry last updated** 2026-08-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Primary completion date** 2028-05-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Start date** 2026-04-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Size and sites **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Planned participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Number of sites** 27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Lead sponsor** Amgen Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Identifiers **Registry ID** NCT07531095 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **ClinicalTrials.gov ID** NCT07531095 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Outcomes ### Primary outcomes 1. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Timeframe: Up to 3.5 years 2. Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) Timeframe: Up to Day 21 ### Secondary outcomes 1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Timeframe: Up to 3.5 years 2. Duration of Response (DOR) per RECIST v1.1 Timeframe: Up to 3.5 years 3. Time to Response (TTR) per RECIST v1.1 Timeframe: Up to 3.5 years 4. Disease Control Rate (DCR) per RECIST v1.1 Timeframe: Up to 3.5 years 5. Progression-free Survival (PFS) per RECIST v1.1 Timeframe: Up to 3.5 years 6. Time to Progression (TTP) per RECIST v1.1 Timeframe: Up to 3.5 years 7. Time to Subsequent Therapy Timeframe: Up to 3.5 years 8. Overall survival (OS) Timeframe: Up to 3.5 years 9. Serum Tarlatamab Concentrations Timeframe: Up to Week 36 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 99 Years **Healthy volunteers** No ### Inclusion criteria - Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. - Participants with Histologically or cytologically confirmed SCLC: - For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy. - For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1. - For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy. Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated. - Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function). ### Exclusion criteria - Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol. - History of interstitial lung disease (ILD)/pneumonitis. - Received thoracic radiation therapy within 90 days prior to first dose of trial intervention. - Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy. - Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload. - Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment. - Enrollment in any tarlatamab clinical trial. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Sites - City of Hope Cancer Center PhoenixGoodyear, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - City of Hope ChicagoZion, United StatesRecruiting - Health Partners Cancer Center at Regions HospitalSaint Paul, United StatesRecruiting - New York University Cancer InstituteNew York, United StatesRecruiting - Baptist Cancer CenterMemphis, United StatesRecruiting - Next VirginiaFairfax, United StatesRecruiting - Monash Medical CentreClayton, AustraliaRecruiting - Institut Jules BordetBrussels, BelgiumRecruiting - Universitair Ziekenhuis GentGhent, BelgiumRecruiting - Ziekenhuis aan de Stroom AugustinusWilrijk, BelgiumRecruiting - Centre Hospitalier Universitaire de Lyon Hopital Louis PradelBron, FranceRecruiting - Hopital de la TimoneMarseille, FranceRecruiting - Gustave RoussyVillejuif, FranceRecruiting - Universitaetsklinikum DresdenDresden, GermanyRecruiting - Universitaetsklinikum WuerzburgWürzburg, GermanyRecruiting - Uniwersyteckie Centrum KliniczneGdansk, PolandRecruiting - Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyGliwice, PolandRecruiting - Hospital Clinico Universitario Virgen de la VictoriaMálaga, SpainRecruiting - Hospital Universitari Vall d HebronBarcelona, SpainRecruiting - Hospital Clinico Universitario de ValenciaValencia, SpainRecruiting - Hospital Universitario Ramon y CajalMadrid, SpainRecruiting - Hospital Universitario 12 de OctubreMadrid, SpainRecruiting - Kantonsspital Sankt GallenSankt Gallen, SwitzerlandRecruiting - Adana Sehir Egitim ve Arastirma HastanesiAdana, Turkey (Türkiye)Recruiting And 2 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## References - Related resource (www.amgentrials.com) Source: [www.amgentrials.com](http://www.amgentrials.com/) ### Other registry identifiers (2) - 2025 - 2025-522888-15-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07531095) ## Related records ### Drugs (2) - [Durvalumab](https://trialight.com/data/asset/durvalumab-bca7c265-7862-46e1-bf29-3dd2fdda4954.md) - [Tarlatamab](https://trialight.com/data/asset/tarlatamab-23a11ca8-5d77-4625-92aa-242339e9a92b.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) Primary condition ### Targets (5) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) - [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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