A Phase 2 Study to Investigate the Safety and Efficacy of Petosemtamab in Adults With Metastatic Non-Small Cell Lung Cancer in Combination With Pembrolizumab as First-Line Treatment
The study will test the efficacy and safety of petosemtamab in combination with Pembrolizumab in first line patients with squamous non-small cell lung cancer and non-squamous non-small cell lung cancer.
• Able to provide written informed consent and is willing and able to comply with all study procedures and contraception requirements
• Age ≥ 18 years at the signing of ICF
• At least 1 measurable lesion as defined by RECIST 1.1
• ECOG performance status of 0 or 1
• Life expectancy ≥ 12 weeks, in the opinion of the Investigator
• Adequate hematologic function
• Creatinine clearance ≥ 60 mL/min calculated according to the Cockroft and Gault formula
• Adequate liver function
• Serum albumin ≥ 3 g/dL
• Serum magnesium and corrected calcium, Grade ≤ 1 alteration
• Participants of childbearing potential must agree to use highly effective contraception methods for the duration of study participation
• Histologically confirmed metastatic (Stage IV) sqNSCLC with PD-L1 TPS ≥ 50%
• No prior systemic treatment for metastatic disease
• Testing is required per local SOC and availability of testing to document absence of actionable genomic tumor aberrations
• Histologically confirmed metastatic (Stage IV) non-squamous NSCLC with PD-L1 TPS ≥ 50%