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A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (HARMONi-3)


Brief Summary
This is a Phase 3 Randomized, Controlled, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer. The primary endpoint is overall survival and key secondary endpoints include progression free survival. response and safety.



Inclusion and Exclusion Criteria

  • Age ≥ 18 years old at the time of enrollment
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Expected life expectancy ≥ 3 months
  • Metastatic (Stage IV) NSCLC
  • Histologically or cytologically confirmed squamous NSCLC
  • Tumor Proportion Score (TPS) with PD-L1 expression percent
  • At least one measurable noncerebral lesion according to RECIST 1.1
  • No prior systemic treatment for metastatic NSCLC

  • Histologic or cytopathologic evidence of the presence of small cell lung carcinoma, or non-squamous NSCLC histology.
  • Known actionable genomic alterations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 or genes for which first-line approved therapies are available
  • Has received any prior therapy for NSCLC in the metastatic setting
  • Major blood vessel invasion or encasement by cancer or intratumor cavitation


Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.

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