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RECRUITING Phase 3

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

NCT07185997 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Firmonertinib
  • DRUG EGFR-TKI inhibitor based on investigator's choice

Study Locations (20)

Other

  • Humanity and Health Clinical Trial Centre — Central
  • National Cancer Centre Singapore — Singapore
  • Curie Oncology (Farrer) — Singapore
  • Gachon University Gil Medical Center — Incheon

Virginia

  • University of Virginia — Charlottesville
  • Virginia Cancer Specialists — Fairfax
  • Shenandoah Oncology, P.C. — Winchester

California

  • University of California Davis Comprehensive Cancer Center — Sacramento
  • UCSF Medical Center-Mission Bay — San Francisco

Texas

  • Texas Oncology — Dallas
  • The University of Texas MD Anderson Cancer Center — Houston

New York

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health — New York

Aichi-ken

  • Aichi Cancer Center — Nagoya

Fukuoka

  • Kurume University Hospital — Kurume-Shi

Hokkaido

  • National Hospital Organization Hokkaido Cancer Center — Sapporo

Trial Details

FieldValue
Enrollment Target 480 participants
Start Date 2025-12-17
Est. Completion 2030-12
Phase Phase 3

Sponsor

ArriVent BioPharma

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07185997

The ClinicalTrials.gov registry entry for NCT07185997 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 480 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ArriVent BioPharma, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 6 conditions, with Non-Small-Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions — of which Firmonertinib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07185997 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Virginia, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07185997 about?

NCT07185997 is a clinical study titled "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". 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 ...

What is the current status of trial NCT07185997?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2025-12-17. Estimated completion is 2030-12.

What conditions does trial NCT07185997 study?

This clinical trial studies the following conditions: Non-Small-Cell Lung Cancer, Metastatic Non-Small-Cell Lung Cancer, Advanced Non-Small-Cell Lung Cancer, EGFR P-Loop and Alpha C-Helix Compressing, EGFR PACC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07185997?

The interventions under investigation include: Firmonertinib (DRUG), EGFR-TKI inhibitor based on investigator's choice (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07185997?

This trial is sponsored by ArriVent BioPharma, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07185997 being conducted?

This trial has 20 study locations across California, New York, Texas, Virginia, Aichi-ken. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial