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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 14, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07185997). This is a study registration, not published results. Lead sponsor: ArriVent BioPharma, Inc.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 480 participants (ESTIMATED). 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. Interventions: DRUG: Firmonertinib; DRUG: EGFR-TKI inhibitor based on investigator's choice. Primary outcome measures: Progression Free Survival (PFS) determined by blinded independent central review (BICR) , Until progression or death, assessed up to approximately 4 years; Confirmed overall response rate (ORR) as determined by BICR , Until progression or death, assessed up to approximately 3 years. Brief 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.