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
Key facts
- Where
- Bron, Caen Cedex 5, Lyon, Lyon Cedex 04, Marseille, Pierre-Bénite, Saint-Herblain, Saint-Herblain Cedex és Toulouse, FranciaországSee the 9 sites
- Phase
- 3. fázis
Where in Franciaország
- Hospices Civils de LyonBron, FranciaországTaking people
- Centre Francois BaclesseCaen Cedex 5, FranciaországTaking people
- Centre Leon BerardLyon, FranciaországTaking people
- Hospices Civils De LyonLyon Cedex 04, FranciaországTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranciaországTaking people
- Hospices Civils de LyonPierre-Bénite, FranciaországTaking people
- Centre Hospitalier Universitaire de NantesSaint-Herblain, FranciaországTaking people
- Institut De Cancerologie De L OuestSaint-Herblain Cedex, FranciaországTaking people
- Centre Hospitalier Universitaire de ToulouseToulouse, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Arrivent Biopharma Inc.
- Trial code
- EU 2025-522151-26-00
- Record updated
- 2026. augusztus 18.
- Original description
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 mutationsRead full original descriptionShow less
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)
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
Inclusion: 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.
Exclusion: 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; 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).