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RECRUITING
NCT07531095
PHASE1

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

Sponsor: Amgen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-04-21

Completion Date

2031-05-21

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DRUG

ZL-1310

ZL-1310 will be administered as an IV infusion.

DRUG

Tarlatamab

Tarlatamab will be administered as an IV infusion.

DRUG

Durvalumab

Durvalumab will be administered as an IV infusion.

Locations (27)

City of Hope Cancer Center Phoenix

Goodyear, Arizona, United States

Moffitt Cancer Center

Tampa, Florida, United States

City of Hope Chicago

Zion, Illinois, United States

Health Partners Cancer Center at Regions Hospital

Saint Paul, Minnesota, United States

New York University Cancer Institute

New York, New York, United States

Baptist Cancer Center

Memphis, Tennessee, United States

Next Virginia

Fairfax, Virginia, United States

Monash Medical Centre

Clayton, Victoria, Australia

Institut Jules Bordet

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Ziekenhuis aan de Stroom Augustinus

Wilrijk, Belgium

Centre Hospitalier Universitaire de Lyon Hopital Louis Pradel

Bron, France

Hopital de la Timone

Marseille, France

Gustave Roussy

Villejuif, France

Universitaetsklinikum Dresden

Dresden, Germany

Universitaetsklinikum Wuerzburg

Würzburg, Germany

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Gliwice, Poland

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Andalusia, Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Kantonsspital Sankt Gallen

Sankt Gallen, Switzerland

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, Turkey (Türkiye)

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, Turkey (Türkiye)