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