RecruitingPhase 1NCT06898957
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
Sponsor
Amgen
Enrollment
200 participants
Start Date
May 16, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria6
- 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 Criteria5
- 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
DRUGYL201
YL201 will be administered as an IV infusion.
DRUGTarlatamab
Tarlatamab will be administered as an IV infusion.
DRUGAtezolizumab
Atezolizumab will be administered as an IV infusion.
DRUGDurvalumab
Durvalumab will be administered as an IV infusion.
Locations(36)
View Full Details on ClinicalTrials.gov
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NCT06898957
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