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)

Last updated: January 28, 2026
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

1

Condition

Small Cell Lung Cancer

Treatment

YL201

Tarlatamab

Atezolizumab

Clinical Study ID

NCT06898957
20240124
  • Ages 18-99
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Participants ≥ 18 years of age (or legal adult age within country) at time ofsigning informed consent.

  • Participants with histologically or cytologically confirmed ES-SCLC.

  • For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurredfollowing at least 1 line of platinum-based anti-cancer therapy.

  • For Part 3, participants must have ES-SCLC and no prior systemic treatment for ESSCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1inhibitor 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, bonemarrow, and liver).

Exclusion

Exclusion Criteria:

  • 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) withtopoisomerase I inhibitor payload.

  • Symptomatic central nervous system (CNS) metastases. Note: Participants withasymptomatic brain metastases are eligible as defined in the protocol.

  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis thatrequired corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis thatcannot be ruled out by imaging at screening.

  • Baseline requirement of supplemental oxygen.

Study Design

Total Participants: 200
Treatment Group(s): 4
Primary Treatment: YL201
Phase: 1
Study Start date:
May 16, 2025
Estimated Completion Date:
April 23, 2031

Connect with a study center

  • CHU de Quebec Hopital de l Enfant Jesus

    Québec 6325494, Quebec 6115047 G1J 1Z4
    Canada

    Active - Recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong 250117
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan 1805753, Shandong 1796328 250117
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 611135
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu 1815286, Sichuan 1794299 611135
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou, 350011
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou 1810821, 350011
    China

    Active - Recruiting

  • Institut Bergonie

    Bordeaux 3031582, 33000
    France

    Active - Recruiting

  • Centre Leon Berard

    Lyon 2996944, 69373
    France

    Active - Recruiting

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse 2972315, 31059
    France

    Active - Recruiting

  • Gustave Roussy

    Villejuif 2968705, 94805
    France

    Active - Recruiting

  • Universitaetsklinikum Essen

    Essen 2928810, 45147
    Germany

    Active - Recruiting

  • Henry Dunant Hospital Center

    Athens 264371, 11526
    Greece

    Active - Recruiting

  • European Interbalkan Medical Center

    Thessaloniki 734077, 57001
    Greece

    Active - Recruiting

  • Iatriko Diavalkaniko Thessalonikis

    Thessaloniki 734077, 57001
    Greece

    Active - Recruiting

  • Semmelweis Egyetem

    Budapest 3054643, 1083
    Hungary

    Active - Recruiting

  • Clinexpert Kft Bugat Pal Korhaz

    Gyöngyös 3052040, 3200
    Hungary

    Active - Recruiting

  • Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS

    Candiolo to, 10060
    Italy

    Active - Recruiting

  • Istituto Romagnolo per lo Studio dei Tumori Dino Amadori

    Meldola (FC) 3173635, 47014
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan 6951411, 20162
    Italy

    Active - Recruiting

  • Asan Medical Center

    Seoul 1835848, 05505
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Active - Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona 3128760, Catalonia 3336901 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, Catalonia 3336901 08041
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda 3117667, Madrid 3117732 28222
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid 3117735, 28041
    Spain

    Active - Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine 5359777, California 5332921 92618
    United States

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Yale New Haven Hospital

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Dana Farber Cancer Institute

    Boston 4930956, Massachusetts 6254926 02215
    United States

    Active - Recruiting

  • Siteman Cancer Center

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Siteman Cancer Center

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota 58122
    United States

    Site Not Available

  • Sanford Roger Maris Cancer Center

    Fargo 5059163, North Dakota 5690763 58122
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Sanford Oncology Clinic and Pharmacy

    Sioux Falls, South Dakota 54104
    United States

    Site Not Available

  • Sanford Oncology Clinic and Pharmacy

    Sioux Falls 5231851, South Dakota 5769223 54104
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98104
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle 5809844, Washington 5815135 98109
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

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