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

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination for adults with extensive stage small cell lung cancer (ES-SCLC), which is a type of lung cancer that usually grows quickly and can spread to other parts of the body. The researchers want to see how safe the combination of tarlatamab and YL201 is, especially when added to another drug that targets a specific protein (called anti-PD-L1).

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of ES-SCLC that has either worsened after at least one type of chemotherapy or has not been treated before (with some specific prior treatments allowed). Participants will have regular check-ups to monitor their health and how well the treatment is working. It's important to know that not everyone can join—those with certain previous treatments or specific health conditions will be excluded. This study is currently not recruiting participants yet, but it aims to find better treatment options for patients facing this challenging disease.

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.