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 assigned dose daily.
Official Title
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)
Keywords
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, Non-Small Cell Lung Cancer (NSCLC), PACC, Firmonertinib, Furmonertinib, AST2818, FURMO-006, Drug-Therapy, Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, NSCLC, Osimertinib, Afatinib, metastatic NSCLC first-line treatment, Carcinoma NSCLC, Respiratory tract neoplasms, Bronchial Neoplasms, Protein Kinase Inhibitors, tyrosine kinase inhibitor (TKI), Alflutinib, Lung neoplasms, EGFR, EGFR kinase domain mutations, EGFR activating mutation, EGFR mutation of unknown significance, Non-classical EGFR mutation, EGFR atypical mutations, G719X, S768I, E709X, E709_T710delinsD, G779F, L747X, V774M, L747P/S, R776C/H, G724S, E736K, I740_K745dup, N771G, K757M/R, V769L/M, Non-Small-Cell Lung Carcinoma, aflutinib, EGFR-TKI inhibitor based on investigator's choice, Firmonertinib 240 mg