RecruitingPhase 1NCT06898957

Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With YL201 With or Without Anti-PD-L1 in Subjects With Extensive Stage Small Cell Lung Cancer

Sponsor

Amgen

Enrollment

200 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Cancer

Summary

The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing combinations of two drugs — tarlatamab and YL201, with or without a third drug (a PD-L1 inhibitor) — in people with extensive-stage small cell lung cancer (SCLC), a fast-growing type of lung cancer. Tarlatamab targets a protein called DLL3 found on SCLC cells, while YL201 targets another protein called B7-H3. Combining these approaches may improve outcomes compared to single-agent treatment. Both newly diagnosed and previously treated patients may be eligible depending on the study part. **You may be eligible if...** - You are 18 years or older (or the legal adult age in your country) - You have confirmed extensive-stage SCLC by biopsy - For Parts 1 and 2: your cancer has progressed after at least one prior platinum-based chemotherapy - For Part 3: you have had no prior treatment for extensive-stage SCLC (or only one prior cycle of chemotherapy + immunotherapy) - You have at least one measurable tumor on imaging - Your heart, lungs, kidneys, and blood counts are adequate **You may NOT be eligible if...** - You have previously received DLL3- or B7-H3-targeted therapy - You have previously received a topoisomerase I inhibitor (such as irinotecan) or antibody-drug conjugate with this type of payload - You have interstitial lung disease or pneumonitis that required steroid treatment - You have symptomatic brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGYL201

YL201 will be administered as an IV infusion.

DRUGTarlatamab

Tarlatamab will be administered as an IV infusion.

DRUGAtezolizumab

Atezolizumab will be administered as an IV infusion.

DRUGDurvalumab

Durvalumab will be administered as an IV infusion.

Locations(36)

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

Moffitt Cancer Center

Tampa, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Siteman Cancer Center

St Louis, Missouri, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Sanford Oncology Clinic and Pharmacy

Sioux Falls, South Dakota, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Swedish Medical Center

Seattle, Washington, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

CHU de Quebec Hopital de l Enfant Jesus

Québec, Quebec, Canada

Shandong Cancer Hospital

Jinan, Shandong, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Fujian Cancer Hospital

Fuzhou, China

Institut Bergonie

Bordeaux, France

Centre Leon Berard

Lyon, France

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, France

Gustave Roussy

Villejuif, France

Universitaetsklinikum Essen

Essen, Germany

Henry Dunant Hospital Center

Athens, Greece

Alexandra Hospital

Athens, Greece

European Interbalkan Medical Center

Thessaloniki, Greece

Iatriko Diavalkaniko Thessalonikis

Thessaloniki, Greece

Semmelweis Egyetem

Budapest, Hungary

Clinexpert Kft Bugat Pal Korhaz

Gyöngyös, Hungary

Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS

Candiolo to, Italy

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

Meldola (FC), Italy

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy

Seoul National University Hospital

Seoul, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

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NCT06898957

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