Phase II Study of Tarlatamab in Patients with Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) and ECOG Performance Status 2

The primary objective is to evaluate the efficacy of tarlatamab in terms of the 12-month overall survival rate in patients with extensive-stage small cell lung cancer exhibiting an ECOG performance status of 2 following progression on prior platinum-etoposide doublet chemotherapy and an immune-checkpoint inhibitor. 5

Secondary objectives include the assessment of:

• Clinical efficacy parameters, specifically objective response rate, duration of response, and progression-free survival. 5
• Safety and tolerability of the therapeutic intervention. 4

This clinical trial involves 10 participants diagnosed with extensive-stage small cell lung cancer. The study population consists of adults who have demonstrated progressive disease following a single line of platinum-etoposide doublet chemotherapy combined with an immune-checkpoint inhibitor. Participants are required to have an ECOG Performance Status of 2. The cohort includes both male and female individuals. Inclusion requires histologically or cytologically confirmed disease, adequate organ function, and a negative pregnancy test for those of childbearing potential.

This phase II clinical trial is designed to evaluate the efficacy of tarlatamab in patients diagnosed with extensive-stage small cell lung cancer (ES-SCLC) and an ECOG performance status of 2. The study population consists of individuals whose disease has progressed following a single line of platinum-etoposide doublet chemotherapy combined with an immune-checkpoint inhibitor. The primary endpoint is the 12-month overall survival rate. Secondary endpoints include the objective response rate, duration of response, disease control rate, and progression-free survival according to RECIST v1.1. Additionally, the trial will monitor the incidence and severity of adverse events, specifically assessing cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, and tumor lysis syndrome using specialized grading criteria. The administration of the investigational product involves intravenous infusion of tarlatamab.

The experimental treatment consists of tarlatamab, which is provided as a solution for injection/infusion or as a powder for solution for infusion. The administration of this substance is conducted via intravenous infusion at a dosage of 10 mg.

The primary efficacy endpoint for this study is the 12-month overall survival rate. Secondary efficacy parameters include the objective response rate, duration of response, and disease control rate. Additionally, progression-free survival will be evaluated.

Assessments for objective response rate and progression-free survival will be conducted according to RECIST v1.1. The evaluation of adverse events will be performed using CTCAE v5, with the exception of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, which are graded according to the ASTCT criteria, and tumor lysis syndrome, which is graded according to the Cairo-Bishop classification.