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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
Trial Status: active
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.
Inclusion Criteria
Key Eligibility Criteria:
- Histologically or cytologically documented, locally advanced or metastatic Non-Small
Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.
- Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR)
PACC mutation in tumor tissue or blood from local testing.
- No prior systemic anticancer therapy regimens received for locally advanced or
metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any
Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR)
TKIs, monoclonal antibodies, or bispecific antibodies).
- Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy,
immunotherapy, or chemo radiotherapy for non-metastatic disease must have
experienced a treatment free interval of at least 12 months.
- Patients with asymptomatic CNS metastases are eligible.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07185997.
