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 or organ invasion
    Note: Encasement by cancer with narrowing of the vessel, or intratumor cavitation are eligible
  • 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 other than China’s National Medical Products Administration (NMPA).

For additional information on the HARMONi-3 Clinical Trial, please contact medinfo@smmttx.com

Ivonescimab Overview

HARMONi-3 Fact Sheet