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Recruiting

Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

NCT07531095 · Amgen
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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
About this study
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.
Eligibility criteria
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.
Study design
Enrollment target: 160 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-04-21
Estimated completion: 2031-05-21
Last updated: 2026-08-21
Interventions
Drug: ZL-1310Drug: TarlatamabDrug: Durvalumab
Primary outcomes
  • Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) (Up to 3.5 years)
  • Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) (Up to Day 21)
Sponsor
Amgen · industry
Contacts & investigators
ContactAmgen Call Center · contact · medinfo@amgen.com · 866-572-6436
InvestigatorMD · study_director, Amgen
All locations (27)
City of Hope Cancer Center PhoenixRecruiting
Goodyear, Arizona, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
City of Hope ChicagoRecruiting
Zion, Illinois, United States
Health Partners Cancer Center at Regions HospitalRecruiting
Saint Paul, Minnesota, United States
New York University Cancer InstituteRecruiting
New York, New York, United States
Baptist Cancer CenterRecruiting
Memphis, Tennessee, United States
Next VirginiaRecruiting
Fairfax, Virginia, United States
Monash Medical CentreRecruiting
Clayton, Victoria, Australia
Institut Jules BordetRecruiting
Brussels, Belgium
Universitair Ziekenhuis GentRecruiting
Ghent, Belgium
Ziekenhuis aan de Stroom AugustinusRecruiting
Wilrijk, Belgium
Centre Hospitalier Universitaire de Lyon Hopital Louis PradelRecruiting
Bron, France
Hopital de la TimoneRecruiting
Marseille, France
Gustave RoussyRecruiting
Villejuif, France
Universitaetsklinikum DresdenRecruiting
Dresden, Germany
Universitaetsklinikum WuerzburgRecruiting
Würzburg, Germany
Uniwersyteckie Centrum KliniczneRecruiting
Gdansk, Poland
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut BadawczyRecruiting
Gliwice, Poland
Hospital Clinico Universitario Virgen de la VictoriaRecruiting
Málaga, Andalusia, Spain
Hospital Universitari Vall d HebronRecruiting
Barcelona, Catalonia, Spain
Hospital Clinico Universitario de ValenciaRecruiting
Valencia, Valencia, Spain
Hospital Universitario Ramon y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Kantonsspital Sankt GallenRecruiting
Sankt Gallen, Switzerland
Adana Sehir Egitim ve Arastirma HastanesiRecruiting
Adana, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi HastanesiRecruiting
Ankara, Turkey (Türkiye)
Izmir Ekonomi Universitesi Medical Point HastanesiRecruiting
Izmir, Turkey (Türkiye)
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC) · TrialPath