NCT07185997View on ClinicalTrials.gov

Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations

PHASE3RecruitingINTERVENTIONAL

Enrollment

480

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

February 28, 2029

Study Completion Date

December 31, 2030

Conditions

Non-Small-Cell Lung CancerMetastatic Non-Small-Cell Lung CancerAdvanced Non-Small-Cell Lung CancerEGFR P-Loop and Alpha C-Helix CompressingEGFR PACCEGFR Uncommon Mutations

Interventions

DRUG

Firmonertinib

240 mg oral, daily firmonertinib tablet

DRUG

EGFR-TKI inhibitor based on investigator's choice

osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Trial Locations (1)

22903

RECRUITING

University of Virginia, Charlottesville