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
| NCT ID | NCT07185997 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | ArriVent BioPharma, Inc. |
| Condition | Non-Small-Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2029-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 480 participants in total. It began in 2025-12-17 with a primary completion date of 2029-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) 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.
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.
Contact & Investigator
Morgan Lam
STUDY DIRECTOR
ArriVent BioPharm
Frequently Asked Questions
Who can join the NCT07185997 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small-Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07185997 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 480 participants.
Is NCT07185997 currently recruiting?
Yes, NCT07185997 is actively recruiting participants. Contact the research team at FURMO006CT@arrivent.com for enrollment information.
Where is the NCT07185997 trial being conducted?
This trial is being conducted at Los Angeles, United States, Sacramento, United States, San Francisco, United States, Vallejo, United States and 11 additional locations.
Who is sponsoring the NCT07185997 clinical trial?
NCT07185997 is sponsored by ArriVent BioPharma, Inc.. The principal investigator is Morgan Lam at ArriVent BioPharm. The trial plans to enroll 480 participants.
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