Study of Firmonertinib for Advanced NSCLC with EGFR PACC Mutations

This study is testing a drug called firmonertinib against standard treatments (osimertinib or afatinib) for people with advanced non-small cell lung cancer (NSCLC). Your cancer must have a specific change in the EGFR gene called a PACC mutation, which will be checked through a biopsy or blood test. The study aims to see if firmonertinib can slow down cancer growth or shrink tumors more effectively than current treatments. Researchers will compare how long people live without their cancer getting worse (progression-free survival) and how many people see their tumors shrink (overall response rate). This is for people who have not had other treatments for their advanced NSCLC.

Study design
This is a global, Phase 3 study where participants will be randomly assigned to receive either firmonertinib or one of the standard treatments. About 480 people are planned to join this study.
What's involved
Participants will take their assigned medication (firmonertinib, osimertinib, or afatinib) as a daily oral tablet. The study will assess outcomes for up to approximately 4 years.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants until their cancer progresses or they pass away, with assessments for progression-free survival up to approximately 4 years and overall response rate up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
ArriVent BioPharma, Inc.
~480 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:FirmonertinibEGFR-TKI inhibitor based on investigator's choice

At a glance

Recruiting sites
88 of 88 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) determined by blinded independent central review (BICR)
Measured over Until progression or death, assessed up to approximately 4 years
+1 more outcome measured
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
EGFR Uncommon Mutations
88 sites across 47 states
California6
South Korea5
Ontario4
Greece4
Spain4
Taiwan4
Turkey (Türkiye)4
Virginia3
  • Jamuna Thimmarayappa · STUDY_DIRECTOR · ArriVent BioPharm

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  • Progression Free Survival (PFS) determined by blinded independent central review (BICR)Until progression or death, assessed up to approximately 4 years

    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.

  • Confirmed overall response rate (ORR) as determined by BICRUntil progression or death, assessed up to approximately 3 years

    Confirmed ORR is defined as the percentage of participants with a confirmed CR or PR based on BICR assessment relative to the total number of participants.