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.
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Progression Free Survival (PFS) determined by blinded independent central review (BICR)
Timeframe: Until progression or death, assessed up to approximately 4 years
Confirmed overall response rate (ORR) as determined by BICR
Timeframe: Until progression or death, assessed up to approximately 3 years