Status:
RECRUITING
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
Lead Sponsor:
ArriVent BioPharma, Inc.
Conditions:
Non-Small-Cell Lung Cancer
Metastatic Non-Small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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) ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT07185997
Start Date
December 1 2025
End Date
December 1 2030
Last Update
November 19 2025
Active Locations (3)
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1
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
2
Texas Oncology
Dallas, Texas, United States, 75246
3
University of Virginia
Charlottesville, Virginia, United States, 22903