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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)

RECRUITINGPhase 1Sponsored by Amgen
Actively Recruiting
PhasePhase 1
SponsorAmgen
Started2025-05-16
Est. completion2031-04-23
Eligibility
Age18 Years – 99 Years
Healthy vol.Accepted
Locations11 sites

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

Locations11 sites

City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, 92618
Yale New Haven Hospital
New Haven, Connecticut, 06510
Moffitt Cancer Center
Tampa, Florida, 33612
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Siteman Cancer Center
St Louis, Missouri, 63110

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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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