Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations

Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.

Trial Details

NCT ID
NCT07185997
Phase
PHASE3
Sponsor
ArriVent BioPharma, Inc.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Firmonertinib
  • EGFR-TKI inhibitor based on investigator's choice
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Sacramento, California, United States|38.58157,-121.4944
  • San Francisco, California, United States|37.77493,-122.41942
  • Vallejo, California, United States|38.10409,-122.25664
  • Arlington Heights, Illinois, United States|42.08836,-87.98063

Key Eligibility Criteria

  • Key Eligibility Criteria:
  • Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or r…
  • Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.
  • No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatm…

For full eligibility, visit ClinicalTrials.gov.

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