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NCT06898957Active, not recruitingPhase 1

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

Source: ClinicalTrials.gov · Last updated 20 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
29 (actual)
First submitted
21 Mar 2025
Start date
16 May 2025
Primary completion date
23 Jun 2031
Lead sponsor
Amgen
Diseases
Lung cancer
NCT number
NCT06898957

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 29
  • From 16 May 2025 to the primary completion date, 23 Jun 2031
  • 36 sites in 10 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
  • Baseline requirement of supplemental oxygen.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (36)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU de Quebec - Hôpital de l' Enfant Jésus
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QuébecCanadaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
Fujian Cancer Hospital
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FuzhouChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
Universitaetsklinikum - Essen
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EssenGermanyUnknown status
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Universitario Puerta de Hierro - Majadahonda
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MajadahondaSpainUnknown status
Institut Bergonie
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BordeauxFranceUnknown status
Centre Leon Berard
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LyonFranceUnknown status
Institut Universitaire du Cancer Toulouse - Oncopole
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ToulouseFranceUnknown status
Gustave Roussy
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VillejuifFranceUnknown status
Alexandra Hospital
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AthensGreeceUnknown status
Henry Dunant Hospital Center
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AthensGreeceUnknown status
Iatriko Diavalkaniko Thessalonikis
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ThessalonikiGreeceUnknown status
European Interbalkan Medical Center
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ThessalonikiGreeceUnknown status
Semmelweis Egyetem
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BudapestHungaryUnknown status
Clinexpert Kft Bugat Pal Korhaz
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GyöngyösHungaryUnknown status
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
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Candiolo toItalyUnknown status
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
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Meldola (FC)ItalyUnknown status
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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MilanItalyUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Cleveland Clinic Foundation
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ClevelandUnited StatesUnknown status
Sanford Roger Maris Cancer Center
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FargoUnited StatesUnknown status
University of Texas - MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
City of Hope Orange County Lennar Foundation Cancer Center
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IrvineUnited StatesUnknown status
Yale New Haven Hospital
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New HavenUnited StatesUnknown status
Swedish Medical Center
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SeattleUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
Sanford Oncology Clinic and Pharmacy
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Sioux FallsUnited StatesUnknown status
Siteman Cancer Center
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St LouisUnited StatesUnknown status
Moffitt Cancer Center
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TampaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.