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
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
Sites (21)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Quironsalud Malaga | Málaga | Spain | Recruiting |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Recruiting |
| University Hospital Son Espases | Palma | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Recruiting |
| Hospices Civils de Lyon | Bron | France | Recruiting |
| Centre Francois Baclesse | Caen Cedex 5 | France | Recruiting |
| Centre Leon Berard | Lyon | France | Recruiting |
| Hospices Civils De Lyon | Lyon Cedex 04 | France | Recruiting |
| Centre Hospitalier Regional De Marseille | Marseille | France | Recruiting |
| Hospices Civils de Lyon | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Saint-Herblain | France | Recruiting |
| Institut De Cancerologie De L Ouest | Saint-Herblain Cedex | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France | Recruiting |
| Thoracic General Hospital of Athens "I Sotiria" | Athens | Greece | Recruiting |
| Henry Dunant Hospital Center | Athens | Greece | Recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" | Chaïdári | Greece | Recruiting |
| Athens Medical Center S.A. | Thessaloniki | Greece | Recruiting |
| Centro di Riferimento Oncologico di Aviano | Aviano | Italy | Recruiting |
| Istituto Europeo di Oncologia s.r.l | Milan | Italy | Recruiting |
| Università degli Studi di Modena e Reggio Emilia | Modena | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.