HARMONi Clinical Trial

• Expected survival ≥3 months
• Locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC that has progressed on 3rd generation EGFR-TKI (e.g., osimertinib)
• At least 1 measurable noncerebral lesion per RECIST v1.1
• Adequate organ and hematologic function
• Prior treatment with one non-EGFR therapy is allowed (e.g., amivantamab, REQORSA)
• Prior treatment with immune checkpoint inhibitors, anti-angiogenic therapy, and chemotherapy (including ADCs) remains exclusionary
• Tumor does not surround important blood vessels, have obvious necrosis and/or cavitation or invade the surrounding vital organs and blood vessels
• No symptomatic metastases of the central nervous system
• No history of esophageal gastric varices, severe ulcers, or wounds that do not heal
• No history of severe bleeding tendencies or coagulopathy, or hemoptysis within last 4 weeks

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA).

Abbreviations: ADCs=antibody-drug conjugates; AUC=area under the curve; DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; HRQoL=health-related quality of life; IRRC=Independent Radiology Review Committee; NSCLC=non-small cell lung cancer; ORR=overall response rate; OS=overall survival; PD-L1=programmed cell death-ligand 1; PFS=progression-free survival; PK=pharmacokinetics; Q3W=every 3 weeks; R=randomization; RECIST=Response Evaluation Criteria in Solid Tumors; TKI=tyrosine kinase inhibitor.