Study on Firmonertinib vs. Other EGFR Inhibitors for Advanced Non-Small Cell Lung Cancer with Uncommon Mutations
Sponsor: ArriVent BioPharma, Inc.
ClinicalTrials ID:NCT07185997
This clinical trial is comparing the effectiveness and safety of the drug firmonertinib to other EGFR inhibitors, osimertinib and afatinib, as a first treatment for patients with advanced non-small cell lung cancer (NSCLC) that has specific uncommon mutations.
Patient Parameters
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Program Overview
The study is a global Phase 3 trial that involves multiple centers and is open-label, meaning both the researchers and participants know which treatment is being given. It aims to evaluate how well firmonertinib works compared to the investigator's choice of either osimertinib or afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has specific uncommon mutations in the EGFR gene. Participants in the study have not received any previous treatment for their advanced cancer. They will be randomly assigned to receive either firmonertinib or one of the other two drugs, and will take the assigned medication daily.
Eligibility 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | 10016 | New York | New York |
| Texas Oncology | 75246 | Dallas | Texas |
| University of Virginia | 22903 | Charlottesville | Virginia |
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