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

ClinicalTrials.gov ID: NCT07185997

Public ClinicalTrials.gov record NCT07185997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 11:20 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07185997
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: ArriVent BioPharma, Inc.; Industry
Enrollment: 480 participants

Conditions and interventions

Conditions

Interventions

Firmonertinib Drug
EGFR-TKI inhibitor based on investigator's choice Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 16, 2025
Primary completion: Jan 31, 2029
Completion: Nov 30, 2030
Last update posted: Aug 31, 2026

2025 – 2030

United States locations

U.S. sites: 20
U.S. states: 10
U.S. cities: 20

Facility	City	State	ZIP	Site status
St. Jude Medical Center	Fullerton	California	92835	Recruiting
USC/Norris Comprehensive Cancer Center	Los Angeles	California	90033	Recruiting
Providence St. Joseph Hospital	Orange	California	92868	Recruiting
University of California Davis Comprehensive Cancer Center	Sacramento	California	95817	Recruiting
UCSF Medical Center-Mission Bay	San Francisco	California	94158	Recruiting
Kaiser Permanente Medical Center	Vallejo	California	94589	Recruiting
University of Colorado Health	Aurora	Colorado	80045	Recruiting
Illinois Cancer Specialists	Arlington Heights	Illinois	60005	Recruiting
University of Illinois Hospital and Health Sciences Systems	Chicago	Illinois	60612	Recruiting
Henry Ford Cancer Institute	Detroit	Michigan	48202	Recruiting
Northwell Health/R.J. Zuckerberg Cancer Center	Lake Success	New York	11042	Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health	New York	New York	10016	Recruiting
Ohio State University Hospitals	Columbus	Ohio	43210	Recruiting
Fox Chase Cancer Center	Philadelphia	Pennsylvania	19111	Recruiting
Texas Oncology	Dallas	Texas	75246	Recruiting
The University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
University of Virginia	Charlottesville	Virginia	22903	Recruiting
Virginia Cancer Specialists	Fairfax	Virginia	22031	Recruiting
Shenandoah Oncology, P.C.	Winchester	Virginia	22601	Recruiting
Swedish Cancer Institute	Edmonds	Washington	98026	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 98 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07185997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 31, 2026 · Synced Sep 1, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07185997 live on ClinicalTrials.gov.

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