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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)
NOT_RECRUITINGPhase 1Sponsored by Amgen
No longer actively recruiting
PhasePhase 1
SponsorAmgen
Started2025-05-16
Est. completion2031-04-23
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
Locations11 sites
View on ClinicalTrials.gov →
NCT06898957
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
Age: 18 Years – 99 YearsHealthy volunteers accepted
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.
Conditions3
CancerLung CancerSmall Cell Lung Cancer
Interventions4
Locations11 sites
City of Hope Orange County Lennar Foundation Cancer Center
Yale New Haven Hospital
New Haven, Connecticut, 06510
Dana Farber Cancer Institute
Siteman Cancer Center
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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No longer actively recruiting
PhasePhase 1
SponsorAmgen
Started2025-05-16
Est. completion2031-04-23
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
Locations11 sites
View on ClinicalTrials.gov →
NCT06898957