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Clinical Trials in the USA / NCT07531095
Recruiting Phase 1

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

NCT07531095 · tracked via the Priya Life Science USA tracker
Sponsor
Amgen
Phase
Phase 1
Started
2026-04-21
Last updated
2026-08-21

Condition(s) studied

Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

ZL-1310TarlatamabDurvalumab

ZL-1310: ZL-1310 will be administered as an IV infusion.

Tarlatamab: Tarlatamab will be administered as an IV infusion.

Durvalumab: Durvalumab will be administered as an IV infusion.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max 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.

Primary outcome measure(s)

Trial sites (27)

FacilityCityRegionStatus
City of Hope Cancer Center Phoenix Goodyear Arizona Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
City of Hope Chicago Zion Illinois Recruiting
Health Partners Cancer Center at Regions Hospital Saint Paul Minnesota Recruiting
New York University Cancer Institute New York New York Recruiting
Baptist Cancer Center Memphis Tennessee Recruiting
Next Virginia Fairfax Virginia Recruiting
Monash Medical Centre Clayton Victoria Recruiting
Institut Jules Bordet Brussels Belgium Recruiting
Universitair Ziekenhuis Gent Ghent Belgium Recruiting
Ziekenhuis aan de Stroom Augustinus Wilrijk Belgium Recruiting
Centre Hospitalier Universitaire de Lyon Hopital Louis Pradel Bron France Recruiting
Hopital de la Timone Marseille France Recruiting
Gustave Roussy Villejuif France Recruiting
Universitaetsklinikum Dresden Dresden Germany Recruiting
Universitaetsklinikum Wuerzburg Würzburg Germany Recruiting
Uniwersyteckie Centrum Kliniczne Gdansk Poland Recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Gliwice Poland Recruiting
Hospital Clinico Universitario Virgen de la Victoria Málaga Andalusia Recruiting
Hospital Universitari Vall d Hebron Barcelona Catalonia Recruiting
Hospital Clinico Universitario de Valencia Valencia Valencia Recruiting
Hospital Universitario Ramon y Cajal Madrid Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
Kantonsspital Sankt Gallen Sankt Gallen Switzerland Recruiting
Adana Sehir Egitim ve Arastirma Hastanesi Adana Turkey (Türkiye) Recruiting
Hacettepe Universitesi Tip Fakultesi Hastanesi Ankara Turkey (Türkiye) Recruiting
Izmir Ekonomi Universitesi Medical Point Hastanesi Izmir Turkey (Türkiye) Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07531095 on ClinicalTrials.gov ↗ ← All trials in the USA