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

Condition(s) studied

Investigational drug(s) / intervention(s)

Firmonertinib: 240 mg oral, daily firmonertinib tablet

EGFR-TKI inhibitor based on investigator's choice: osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Study 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.

Eligibility

Primary outcome measure(s)

• Progression Free Survival (PFS) determined by blinded independent central review (BICR) — Until progression or death, assessed up to approximately 4 years
  PFS is defined as the time from randomization to the first occurrence of disease progression as determined by BICR using RECIST v1.1, or death from any cause, whichever occurs first.
• Confirmed overall response rate (ORR) as determined by BICR — Until progression or death, assessed up to approximately 3 years
  Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on BICR assessment relative to the total number of participants.

Trial sites (118)

+ 78 more sites — see the full list on the official registry below.

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