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

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 118 → 139 locations
    • Interventions: EGFR-TKI inhibitor based on investigator's choice (Drug), Firmonertinib (Drug) to EGFR-TKI inhibitor based on investigator's choice (Drug), Firmonertinib (Drug)
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: details revised at 1 of 7 entries
  2. Trial sites expanded: 88 → 118 locationsv14
  3. Trial sites expanded: 78 → 88 locationsv13
  4. Trial sites expanded: 74 → 78 locationsv12
  5. Trial sites expanded: 62 → 74 locationsv11
  6. Study sites: 61 to 62v10
  7. Trial sites expanded: 56 → 61 locationsv9
  8. Study sites: 54 to 56v8
  9. Study sites: 53 to 54v7
  10. Trial sites expanded: 50 → 53 locationsv6
  11. Study sites: 23 to 50v5
  12. Study sites: 3 to 23
    • Start date changed from estimate of Dec 2025 to Dec 17, 2025
    v4
  13. Study sites: 1 to 3v3
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  15. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT07185997
Lead Sponsor ArriVent BioPharma, Inc.
Conditions
(from sponsor)		 Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer, EGFR P-Loop and Alpha C-Helix Compressing, EGFR PACC, EGFR Uncommon Mutations
Related terms Bronchial Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Respiratory Tract Neoplasms
Enrollment 480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov