Trial Now Recruiting: 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 (NCT07185997)
WHY IT MATTERS
This trial is actively recruiting patients with EGFR PACC mutations—a rare subset of lung cancer—and offers access to firmonertinib, a potentially more effective treatment option compared to standard first-line therapies.
Researchers are looking for patients with a specific type of lung cancer (non-small-cell lung cancer with EGFR PACC mutations) who have never received treatment for advanced disease. This study will test whether a new drug called firmonertinib works better and is safer than two existing drugs (osimertinib or afatinib) that doctors currently use. About 480 patients will be enrolled worldwide.
NCT ID: NCT07185997 Status: RECRUITING Conditions: 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 Phase: PHASE3 Enrollment: 480 Sponsor: ArriVent BioPharma, Inc. Summary: 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
YOU CAN ACT ON THIS
If you have locally advanced or metastatic NSCLC with confirmed EGFR PACC mutations and have not yet received treatment for advanced disease, contact your oncologist immediately to discuss eligibility or visit clinicaltrials.gov (NCT07185997) to find participating sites near you.