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NCT07185997 | RECRUITING | Non-Small-Cell Lung Cancer

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
Sponsor:

ArriVent BioPharma, Inc.

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.

Condition or disease

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

Intervention/treatment

Firmonertinib

EGFR-TKI inhibitor based on investigator's choice

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 480 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)
Actual Study Start Date : 2025-12
Estimated Primary Completion Date : 2029-02
Estimated Study Completion Date : 2030-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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

Location Details

NCT07185997

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How to Participate

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Locations

RECRUITING

United States, New York

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States, 10016

RECRUITING

United States, Texas

Texas Oncology

dallas, Texas, United States, 75246

RECRUITING

United States, Virginia

University of Virginia

Charlottesville, Virginia, United States, 22903