Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy andsafety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice ofosimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advancedor metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapyfor advanced disease. Participants will be randomized in a 1:1 ratio to treatment withfirmonertinib or osimertinib or afatinib and will take the assigned dose daily.
Not Provided
Drug: Firmonertinib
240 mg oral, daily firmonertinib tablet
Other Name: AST2818
Drug: EGFR-TKI inhibitor based on investigator's choice
osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet
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.
University of Virginia
Charlottesville 4752031, Virginia 6254928, United States
Vanessa Esquibel
619-540-3451
FURMO006CT@arrivent.com
Morgan Lam, Study Director
ArriVent BioPharm