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)

Launched by AMGEN · Mar 21, 2025

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Gender

ALL

Eligibility criteria

• 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.

Trial Officials