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NCT07531095PHASE1Recruiting

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

Amgen

Start Date

4/21/2026

Completion Date

5/21/2031

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 Criteria

Age Range: 18 years to 99 years

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.

Interventions

DRUG

ZL-1310

DRUG

Tarlatamab

DRUG

Durvalumab

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Conditions

Small Cell Lung Cancer

Locations

City of Hope Cancer Center Phoenix

Goodyear, Arizona 85338

United States

Moffitt Cancer Center

Tampa, Florida 33612

United States

City of Hope Chicago

Zion, Illinois 60099

United States

Health Partners Cancer Center at Regions Hospital

Saint Paul, Minnesota 55101

United States

New York University Cancer Institute

New York, New York 10016

United States

Baptist Cancer Center

Memphis, Tennessee 38120

United States

Next Virginia

Fairfax, Virginia 22031

United States

Monash Medical Centre

Clayton, Victoria 3168

Australia

Institut Jules Bordet

Brussels, B-1070

Belgium

Universitair Ziekenhuis Gent

Ghent, 9000

Belgium

Ziekenhuis aan de Stroom Augustinus

Wilrijk, 2610

Belgium

Centre Hospitalier Universitaire de Lyon Hopital Louis Pradel

Bron, 69677

France

Hopital de la Timone

Marseille, 13005

France

Gustave Roussy

Villejuif, 94805

France

Universitaetsklinikum Dresden

Dresden, 01307

Germany

Universitaetsklinikum Wuerzburg

Würzburg, 97078

Germany

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Gliwice, 44-102

Poland

Hospital Clinico Universitario Virgen de la Victoria

Málaga, Andalusia 29010

Spain

Hospital Universitari Vall d Hebron

Barcelona, Catalonia 08035

Spain

Hospital Clinico Universitario de Valencia

Valencia, Valencia 46010

Spain

Hospital Universitario Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Kantonsspital Sankt Gallen

Sankt Gallen, 9007

Switzerland

Adana Sehir Egitim ve Arastirma Hastanesi

Adana, 01370

Turkey (Türkiye)

Hacettepe Universitesi Tip Fakultesi Hastanesi

Ankara, 06230

Turkey (Türkiye)

Izmir Ekonomi Universitesi Medical Point Hastanesi

Izmir, 35575

Turkey (Türkiye)