A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)
This study is testing a new medication called firmonertinib to see if it works better than current standard treatments for a specific type of lung cancer. It focuses on patients whose cancer has certain rare genetic changes, known as EGFR PACC mutations, which help doctors choose the best targeted therapy.
This trial is for patients with non-small-cell lung cancer that has spread or cannot be removed by surgery and carries specific rare genetic mutations. You must not have received any previous treatments for your advanced lung cancer to be eligible.
Participants will be randomly assigned to take either the new drug, firmonertinib, or one of the standard comparison medications as a daily pill. Your medical team will monitor your health closely to see how the cancer responds to the treatment and to keep you safe.
This study is currently recruiting patients at various medical centers in Los Angeles, Sacramento, and San Francisco, California. Because this is a global Phase 3 study, it is a significant step in determining if this new treatment could become a new standard of care.
- 1The study compares a new targeted pill against existing approved medications.
- 2Targeted therapy works by blocking specific proteins that help cancer cells grow.
- 3Participation requires having a specific genetic profile in your cancer cells.
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