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NCT07185997 · ClinicalTrials.gov registry record · 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
A Phase 3 study of Non-Small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer, sponsored by ArriVent BioPharma.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 480
- Enrollment target
- 20
- Study locations
NCT07185997: Recruiting Phase 3 study of Non-Small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer, sponsored by ArriVent BioPharma.
NCT07185997 is a Phase 3 study of Non-Small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer that is actively recruiting participants, run by ArriVent BioPharma. The registered enrollment target is 480 participants, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (26% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07185997, a Phase 3 study of Non-Small Cell Lung Cancer and Metastatic Non Small Cell Lung Cancer, is actively recruiting participants, sponsored by ArriVent BioPharma.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 480 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by BICR using RECIST v1.1, or death from any cause, whichever occurs first.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2025-12-17 |
| Est. Completion | 2030-12 |
| Phase | Phase 3 |
What NCT07185997 shows while recruiting
NCT07185997 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, below the 651-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (26% lower).
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.
NCT07185997 names 20 study sites across 13 states, led by Other, Virginia, California.
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.
What interventions are being tested in trial NCT07185997?
The interventions under investigation include: Firmonertinib (DRUG), EGFR-TKI inhibitor based on investigator's choice (DRUG).
Who is sponsoring clinical trial NCT07185997?
This trial is sponsored by ArriVent BioPharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT07185997's enrollment target sits among peer trials
480 82nd of 454 higher than 372 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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