HARMONi-3 Phase 3 Clinical Trial
1L Metastatic NSCLC
NCT05899608: Click to view on ClinicalTrials.gov
A randomized, double-blind, multi-regional phase 3 Study of ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy for the first-line treatment of metastatic NSCLC.
HARMONi-3 Study Schema
Key Eligibility Criteria
- Metastatic (Stage IV) NSCLC
- Histologically or cytologically confirmed squamous or non-squamous NSCLC
- Patients must have Tumor Proportion Score (TPS) with PD-L1 expression prior to randomization
- No prior systemic treatment for metastatic NSCLC. No histologic or cytopathologic evidence of the presence of small cell lung carcinoma
- No known actionable genomic alterations in EGFR, ALK, ROS1 or BRAF V600E or genes for which first-line approved therapies are available
- No Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.
- No symptomatic CNS metastases or CNS metastasis ≥1.5 cm
- No history of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks (including GI bleeding, hemoptysis)
Ivonescimab is an investigational therapy not presently approved by any regulatory authority
other than China’s National Medical Products Administration (NMPA).
Abbreviations: ALK=anaplastic lymphoma kinase; CNS=central nervous system; DCR=disease control rate; DOR=duration of response; ECOG=eastern cooperative oncology group; EGFR=epidermal growth factor receptor; IRRC=independent radiologic review committee; NSCLC=non-small cell lung cancer; ORR=overall response rate; OS=overall survival; PD-1=programmed cell death protein 1; PD-L1=programmed death-ligand 1; PFS=progression-free survival; PK=pharmacokinetics; Q3W=every 3 weeks; VEGF=vascular endothelial growth factor.
For additional information on the HARMONi-3 Clinical Trial, please contact medinfo@smmttx.com
