Status:
RECRUITING
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)
Lead Sponsor:
Amgen
Collaborating Sponsors:
MediLink
Conditions:
Small Cell Lung Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 23 2031
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06898957
Start Date
May 16 2025
End Date
April 23 2031
Last Update
December 5 2025
Active Locations (24)
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1
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215