Dysautonomia International

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

Purpose

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

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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 Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Firmonertinib 240 mg		Drug: Firmonertinib 240 mg oral, daily firmonertinib tablet Other names: AST2818
Active Comparator EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice		Drug: EGFR-TKI inhibitor based on investigator's choice osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Recruiting Locations

University of California Davis Comprehensive Cancer Center
Sacramento 5389489, California 5332921 95817

UCSF Medical Center-Mission Bay
San Francisco 5391959, California 5332921 94158

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York 5128581, New York 5128638 10016

Texas Oncology
Dallas 4684888, Texas 4736286 75246

The University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030

University of Virginia
Charlottesville 4752031, Virginia 6254928 22903

Virginia Cancer Specialists
Fairfax 4758023, Virginia 6254928 22031

Shenandoah Oncology, P.C.
Winchester 4794120, Virginia 6254928 22601

More Details

Status: Recruiting
Sponsor: ArriVent BioPharma, Inc.

Study Contact

Vanessa Esquibel
619-540-3451
FURMO006CT@arrivent.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.