OncoMatch/Clinical Trials/NCT07185997
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
Is NCT07185997 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Firmonertinib and EGFR-TKI inhibitor based on investigator's choice for non-small-cell lung cancer.
Treatment: Firmonertinib · EGFR-TKI inhibitor based on investigator's choice — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR pacc mutation
Prior therapy
Cannot have received: systemic anticancer therapy
Exception: prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease allowed if treatment free interval of at least 12 months
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- USC/Norris Comprehensive Cancer Center · Los Angeles, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- UCSF Medical Center-Mission Bay · San Francisco, California
- Kaiser Permanente Medical Center · Vallejo, California
- Illinois Cancer Specialists · Arlington Heights, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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