Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
- 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.
- Acronym
- DeLLphi-313
- Short title
- Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2031-05-21
- First posted
- 2026-04-15
- Registry last updated
- 2026-08-21
- Primary completion date
- 2028-05-21
- Start date
- 2026-04-21
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Amgen
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07531095
- ClinicalTrials.gov ID
- NCT07531095
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 3.5 years
Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Timeframe: Up to Day 21
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Timeframe: Up to 3.5 years
Duration of Response (DOR) per RECIST v1.1
Timeframe: Up to 3.5 years
Time to Response (TTR) per RECIST v1.1
Timeframe: Up to 3.5 years
Disease Control Rate (DCR) per RECIST v1.1
Timeframe: Up to 3.5 years
Progression-free Survival (PFS) per RECIST v1.1
Timeframe: Up to 3.5 years
Time to Progression (TTP) per RECIST v1.1
Timeframe: Up to 3.5 years
Time to Subsequent Therapy
Timeframe: Up to 3.5 years
Overall survival (OS)
Timeframe: Up to 3.5 years
Serum Tarlatamab Concentrations
Timeframe: Up to Week 36
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Healthy volunteers
- No
- 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).
- 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.
- 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.
- Related resource (www.amgentrials.com)
- 2025
- 2025-522888-15-00
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Small cell lung carcinoma Primary condition