HARMONi Phase 3 Clinical Trial

EGFR+ Advanced NSCLC Who Have Progressed After 3rd Generation EGFR-TKI (osimertinib)

NCT06396065: Click to view on ClinicalTrials.gov

A randomized, double-blind, multi-center, phase 3 study of SMT112 or placebo combined with pemetrexed and carboplatin in patients with EGFR-mutant locally advanced or metastatic non-squamous NSCLC who have progressed on EGFR-TKI treatment.

HARMONi Study Schema

Key Eligibility Criteria

  • Expected survival ≥3 months
  • Locally advanced (Stage IIIB/IIIC) or metastatic NSCLC that has progressed on 3rd generation EGFR-TKI (e.g., osimertinib)
  • At least 1 measurable noncerebral lesion
  • Adequate organ and hematologic function
  • Has not received other systemic antitumor therapy for the advanced stage (IIIB to IV) of NSCLC
  • 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 that is not approved by any regulatory authority.

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