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

Part of paid clinical trials in Los Angeles, California.

Sponsor
ArriVent BioPharma, Inc.
Study ID
NCT07185997
Phase
PHASE3
Status
Recruiting
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Conditions

  • Advanced Non-Small-Cell Lung Cancer
  • EGFR P-Loop and Alpha C-Helix Compressing
  • EGFR PACC
  • EGFR Uncommon Mutations
  • Metastatic Non-Small-Cell Lung Cancer
  • Non-Small-Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Firmonertinib — DRUG
    240 mg oral, daily firmonertinib tablet
  • EGFR-TKI inhibitor based on investigator's choice — DRUG
    osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet

Study Details

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.

Key Dates

Start date
Dec 17, 2025
Status verified
Jun 2026
Primary completion
Feb 28, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Firmonertinib 240 mg
  • Active Comparator: EGFR-TKI inhibitor osimertinib or afatinib based on investigator's choice

Primary Outcome Measure

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

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
UCSF Medical Center-Mission BaySan FranciscoCalifornia94158-
Kaiser Permanente Medical CenterVallejoCalifornia94589-
Illinois Cancer SpecialistsArlington HeightsIllinois60005-
University of Illinois Hospital and Health Sciences SystemsChicagoIllinois60612-
Northwell Health/R.J. Zuckerberg Cancer CenterLake SuccessNew York11042-
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016-
Ohio State University HospitalsColumbusOhio43210-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Texas OncologyDallasTexas75246-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
University of VirginiaCharlottesvilleVirginia22903-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Shenandoah Oncology, P.C.WinchesterVirginia22601-
Swedish Cancer InstituteEdmondsWashington98026-

Find similar trials in Los Angeles, CA

By research site
USC/Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAUCSF Medical Center-Mission Bay· San Francisco, CAKaiser Permanente Medical Center· Vallejo, CAIllinois Cancer Specialists· Arlington Heights, ILUniversity of Illinois Hospital and Health Sciences Systems· Chicago, IL

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