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)

Running, not enrolling · Phase 1

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT06898957

Run by

Amgen

People needed

29

Starts

2025-05-16

Expected to finish

2031-06-23

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
• Participants with histologically or cytologically confirmed ES-SCLC.
• For Parts 1 and 2, subjects must have ES-SCLC that has progressed or recurred following at least 1 prior line of platinum-based anti-cancer therapy received either for LS-SCLC or ES-SCLC.
• For Part 3, subjects must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, and etoposide, and with or without PD-(L)1 inhibitor in the first-line setting.
• At least 1 measurable lesion as defined by RECIST 1.1.
• Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).

You may not qualify if…

• Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.
• Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
• Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
• History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
• Baseline requirement of supplemental oxygen.

Where it is running

• 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

Full record on ClinicalTrials.gov

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