This is an open-label, non-randomized, sequential-assignment Phase 1b trial evaluating the safety, tolerability, pharmacokinetics, and efficacy of tarlatamab in combination with ZL-1310, administered with or without an anti-PD-L1 antibody (durvalumab) in small cell lung cancer (SCLC). The primary objective of the study is to establish the safety profile, tolerability, and to determine the maximum tolerated combination dose (MTCD) and/or the recommended Phase 2 dose (RP2D) of the regimen. Eligible participants include adult patients with histologically or cytologically confirmed SCLC that has progressed or recurred following at least one line of prior platinum-based chemotherapy. Patients must present with an ECOG performance status of 0 or 1 and have at least one measurable lesion per RECIST v1.1 at baseline. Allocation is non-randomized with participants assigned to sequential treatment cohorts receiving open-label active interventions. Key secondary endpoints include the characterization of the pharmacokinetic profiles and preliminary anti-tumor efficacy measures such as objective response rate and progression-free survival.
This clinical trial evaluates a new treatment approach for patients with small cell lung cancer, an aggressive form of lung cancer. The study tests the investigational medications tarlatamab and ZL-1310 in combination, with or without an additional anti-PD-L1 immunotherapy agent. The primary objective of this early-phase clinical research is to thoroughly assess the safety, tolerability, and pharmacokinetics of this new drug combination. Eligible participants are adult patients whose small cell lung cancer has progressed or recurred following at least one prior line of platinum-based anti-cancer therapy. Molecular status and specific tumor indicators are evaluated during the screening period to confirm eligibility. Important secondary objectives include assessing the anti-tumor efficacy and preliminary clinical response to the combination treatment.
