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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 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2026-05-11

No results posted yet for this 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.

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
  • EGFR Uncommon Mutations

Interventions

DRUG

Firmonertinib

240 mg oral, daily firmonertinib tablet

DRUG

EGFR-TKI inhibitor based on investigator's choice

osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Sponsors & Collaborators

  • ArriVent BioPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Morgan Lam · ArriVent BioPharm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-17
Primary Completion
2029-02-28
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Greece
  • Hong Kong
  • Italy
  • Japan
  • Malaysia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185997 on ClinicalTrials.gov