Phase 2 Study of Petosemtamab in Combination with Pembrolizumab in Adults with Non-Small Cell Lung Cancer

The primary objective of this study is to evaluate the antitumor activity of petosemtamab in combination with pembrolizumab in adults with non-small cell lung cancer (5). The secondary objectives include:

• Further assessment of antitumor activity
• Evaluation of safety and tolerability (4)
• Characterization of the pharmacokinetics (6)
• Characterization of immunogenicity
• Correlation of biomarkers in tumor samples

This clinical trial involves 90 participants diagnosed with non-small cell lung cancer. The study population includes both male and female patients within the age ranges categorized as 3 and 4. Inclusion requirements necessitate an ECOG performance status of 0 or 1 and a life expectancy of at least 12 weeks. Eligible subjects must demonstrate adequate hematologic function, specifically maintaining a platelet count $\ge$ 100 $\times$ 10⁹/L, an absolute neutrophil count $\ge$ 1.5 $\times$ 10⁹/L, and hemoglobin $\ge$ 9 g/dL. Additionally, participants must have a creatinine clearance $\ge$ 60 mL/min. The selection process requires the presence of at least one measurable lesion as defined by RECIST 1.1 criteria through radiologic methods.

This Phase 2 clinical trial is designed to investigate the safety and efficacy of petosemtamab in combination with pembrolizumab in adults diagnosed with non-small cell lung cancer. The study aims to assess antitumor activity, with the primary endpoint being the objective response rate as determined by investigator assessment using RECIST 1.1. Secondary endpoints include duration of response, disease control rate, clinical benefit rate, progression-free survival, and overall survival. The administration of both investigational products will be conducted via intravenous infusion. The clinical sequence involves a screening visit to evaluate eligibility based on criteria such as hematologic function, creatinine clearance, ECOG performance status, and the presence of measurable lesions. Subsequent study visits will include follow-up assessments to monitor adverse events and clinical laboratory data. The total duration of the study is estimated to extend through 2030.

Petosemtamab is administered as a solution for infusion. The dosage is 1500 mg, which is delivered via intravenous infusion.

Pembrolizumab is administered as a solution for infusion. The dosage is 400 mg, which is delivered via intravenous infusion.

The primary efficacy endpoint is the objective response rate (ORR) determined by investigator assessment according to RECIST 1.1. Secondary efficacy parameters include duration of response (DoR), disease control rate (DCR), clinical benefit rate (CBR), progression-free survival (PFS), and overall survival (OS), all evaluated via investigator assessment using RECIST 1.1. An integrated analysis will also be conducted utilizing a population pharmacokinetic (popPK) model approach.