Clinical Trials | 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)

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with Locally Advanced or Metastatic Non-Small-Cell Lung Cancer. The purpose of this study is to learn about the effectiveness and safety of firmonertinib and to compare the effects, good or bad, with those of osimertinib or afatinib. Firmonertinib is an experimental (also referred to as “investigational”) drug, which means that the FDA has not approved firmonertinib for the treatment of any disease. Everyone who takes part in this study will receive study treatment with the study drug(s). If you are randomized to firmonertinib, you will receive firmonertinib tablets (each tablet is 40-mg strength). The assigned dose will be taken by mouth, up to 6 tablets each day, at approximately the same time, on an empty stomach, as directed by the study doctor. If you are randomized to osimertinib, you will receive osimertinib tablets (each tablet is 40- or 80-mg strength). The assigned dose will be taken by mouth, as directed by the study doctor. If you are randomized to afatinib, you will receive afatinib tablets (each tablet is 20-, 30-, or 40-mg strength). The assigned dose will be taken by mouth, as directed by the study doctor. Very common side effects (occur in more than 10 out of 100 participants) are as follows: • Increase in liver enzymes (substances in the body that show how the liver is working) • QTc interval prolongation (heart muscle takes longer than normal to recharge between beats) • Diarrhea (frequent loose, watery stools) • Rash (skin rash) • Stomatitis (sores, swelling, or ulcer inside the mouth) You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. Your total time in the study will depend on how your lung cancer responds to study treatment. This could range from 1 day to 60 months (5 years). For questions, contact: [email protected]