A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination with ZL-1310 with or without Anti-PD-L1 in Participants with Small Cell Lung Cancer (NCT07531095)

This is a phase 1b, open-label, multi-center trial of tarlatamab in combination with ZL-1310 with or without an anti-programmed death ligand 1 (PD-L1) in participants with small cell lung cancer (SCLC). This study is being done to learn more about how to treat SCLC, a disease in which cancer cells form in the tissues of the lung and may spread to other parts of the body such as the opposite lung, bone, brain, or bone marrow. The study will look at whether tarlatamab in combination with ZL-1310 (in Part 1 and Part 2) or tarlatamab, ZL-1310 and durvalumab (in Part 3) could be used to treat SCLC.

Trial phase

Phase 1

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Ben Markman

Key inclusion data

Histologically or cytologically confirmed SCLC o For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy. o For Part 2, participants must have previously treated SCLC that has progressed or recurred following one line of platinum-based anti-cancer therapy. o For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES-SCLC other than 1 cycle of platinum-based anti-cancer therapy. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. • Participants must have at least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.