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)
NCT ID: NCT06898957
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2025-05-16
2031-04-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Exploration (Part 1)
Multiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing.
YL201
YL201 will be administered as an IV infusion.
Tarlatamab
Tarlatamab will be administered as an IV infusion.
Dose Expansion (Part 2)
YL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose.
YL201
YL201 will be administered as an IV infusion.
Tarlatamab
Tarlatamab will be administered as an IV infusion.
Triplet Combination (Part 3)
YL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (atezolizumab or durvalumab) administered IV at a fixed dose.
YL201
YL201 will be administered as an IV infusion.
Tarlatamab
Tarlatamab will be administered as an IV infusion.
Atezolizumab
Atezolizumab will be administered as an IV infusion.
Durvalumab
Durvalumab will be administered as an IV infusion.
Interventions
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YL201
YL201 will be administered as an IV infusion.
Tarlatamab
Tarlatamab will be administered as an IV infusion.
Atezolizumab
Atezolizumab will be administered as an IV infusion.
Durvalumab
Durvalumab will be administered as an IV infusion.
Eligibility Criteria
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Inclusion Criteria
* Participants with histologically or cytologically confirmed ES-SCLC.
* For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
* For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and 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).
Exclusion Criteria
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
MediLink
UNKNOWN
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
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
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
European Interbalkan Medical Center
Thessaloniki, , Greece
Iatriko Diavalkaniko Thessalonikis
Thessaloniki, , Greece
Clinexpert Kft Bugat Pal Korhaz
Gyöngyös, , Hungary
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
Candiolo to, , Italy
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20240124
Identifier Type: -
Identifier Source: org_study_id