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2025-522151-26-00RecruitingPhase 3

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

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)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Aug 2026

Next steps

Brief summary (registry, in English)

1. To assess the anti-tumor activity of firmonertinib compared with investigator’s choice of osimertinib or afatinib in participants with locally advanced or metastatic NSCLC with EGFR PACC mutations

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
36 (estimated)
First submitted
15 Aug 2025
Start date
6 Feb 2026
Lead sponsor
Arrivent Biopharma Inc.
Diseases
Lung cancer
EU CT number
2025-522151-26-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 36
  • 21 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have had prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC not amenable to curative surgery or radiation, including chemotherapy, biologic therapy, immunotherapy, or any investigational drug
  • Have had previous interstitial lung disease (ILD), including drug-induced ILD, or active ILD/active radiation pneumonitis

Lab values

  • Have NSCLC with any of the following EGFR mutations: exon 19 deletion, L858R, or C797S
  • Have had prior treatment with EGFR-targeted agents (eg, EGFR-TKIs, EGFR-targeted proteolysis-targeting chimeras [PROTACs], monoclonal antibodies, or bispecific antibodies)
  • Have a mean resting corrected QT interval (QTc) > 470 ms, obtained from triplicate electrocardiograms (ECGs) with QT interval corrected by Fridericia’s method (QTcF)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (21)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Hospital Clinic de BarcelonaBarcelonaSpainRecruiting
Hospital Quironsalud MalagaMálagaSpainRecruiting
Hospital Universitario Central De AsturiasOviedoSpainRecruiting
University Hospital Son EspasesPalmaSpainRecruiting
Hospital Universitario Y Politecnico La FeValenciaSpainRecruiting
Hospices Civils de LyonBronFranceRecruiting
Centre Francois BaclesseCaen Cedex 5FranceRecruiting
Centre Leon BerardLyonFranceRecruiting
Hospices Civils De LyonLyon Cedex 04FranceRecruiting
Centre Hospitalier Regional De MarseilleMarseilleFranceRecruiting
Hospices Civils de LyonPierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire de NantesSaint-HerblainFranceRecruiting
Institut De Cancerologie De L OuestSaint-Herblain CedexFranceRecruiting
Centre Hospitalier Universitaire de ToulouseToulouseFranceRecruiting
Thoracic General Hospital of Athens "I Sotiria"AthensGreeceRecruiting
Henry Dunant Hospital CenterAthensGreeceRecruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"ChaïdáriGreeceRecruiting
Athens Medical Center S.A.ThessalonikiGreeceRecruiting
Centro di Riferimento Oncologico di AvianoAvianoItalyRecruiting
Istituto Europeo di Oncologia s.r.lMilanItalyRecruiting
Università degli Studi di Modena e Reggio EmiliaModenaItalyRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.