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Active (not recruiting) Phase 1 NCT06898957

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)

Phase 1 – testing safety in a small group of people
Conditions: Small Cell Lung Cancer

Sponsor: Amgen

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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, 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 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.
Interventions
YL201
DRUG
Tarlatamab
DRUG
Atezolizumab
DRUG
Durvalumab
DRUG
Locations 36
Canada (1)
CHU de Quebec Hopital de l Enfant Jesus
Québec , Quebec
China (3)
West China Hospital of Sichuan University
Chengdu , Sichuan
Fujian Cancer Hospital
Fuzhou
Shandong Cancer Hospital
Jinan , Shandong
France (4)
Institut Bergonie
Bordeaux
Centre Leon Berard
Lyon
Institut Universitaire du Cancer Toulouse Oncopole
Toulouse
Gustave Roussy
Villejuif
Germany (1)
Universitaetsklinikum Essen
Essen
Greece (4)
Henry Dunant Hospital Center
Athens
Alexandra Hospital
Athens
European Interbalkan Medical Center
Thessaloniki
Iatriko Diavalkaniko Thessalonikis
Thessaloniki
Hungary (2)
Semmelweis Egyetem
Budapest
Clinexpert Kft Bugat Pal Korhaz
Gyöngyös
Italy (3)
Istituto di Candiolo Fondazione del Piemonte per l Oncologia IRCCS
Candiolo to
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
Meldola (FC)
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan
South Korea (3)
Seoul National University Hospital
Seoul
Severance Hospital Yonsei University Health System
Seoul
Asan Medical Center
Seoul
Spain (4)
Hospital Universitari Vall d Hebron
Barcelona , Catalonia
Hospital de la Santa Creu i Sant Pau
Barcelona , Catalonia
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda , Madrid
United States (11)
Dana Farber Cancer Institute
Boston , Massachusetts
Cleveland Clinic Foundation
Cleveland , Ohio
Sanford Roger Maris Cancer Center
Fargo , North Dakota
University of Texas MD Anderson Cancer Center
Houston , Texas
City of Hope Orange County Lennar Foundation Cancer Center
Irvine , California
Yale New Haven Hospital
New Haven , Connecticut
Swedish Medical Center
Seattle , Washington
Fred Hutchinson Cancer Center
Seattle , Washington
Sanford Oncology Clinic and Pharmacy
Sioux Falls , South Dakota
Siteman Cancer Center
St Louis , Missouri
Moffitt Cancer Center
Tampa , Florida
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
16.05.2025
Completion date
23.06.2031
Registry ID
NCT06898957
Source
clinicaltrials.gov
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