HARMONi-3 Phase 3 Clinical Trial
1L Metastatic Squamous NSCLC
NCT05899608: Click to view on ClinicalTrials.gov
A randomized, controlled, multi-regional phase 3 Study of ivonescimab combined with chemotherapy versus pembrolizumab combined with chemotherapy for the first-line treatment of metastatic squamous NSCLC.
HARMONi-3 Study Schema
Key Eligibility Criteria
- Metastatic (Stage IV) NSCLC
- Histologically or cytologically confirmed squamous NSCLC
- Patients must have Tumor Proportion Score (TPS) with PD-L1 expression percent
- No prior systemic treatment for metastatic NSCLC
- No histologic or cytopathologic evidence of the presence of small cell lung carcinoma, or non-squamous NSCLC histology
- No known actionable genomic alterations in EGFR, ALK, ROS1 or genes for which first-line approved therapies are available
- No radiologically documented evidence of major blood vessel invasion, encasement by cancer, or evidence of intratumor cavitation
- 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 that is not approved by any regulatory authority.
For additional information on the HARMONi-3 Clinical Trial, please contact medinfo@smmttx.com