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Taking people in GreecePhase 3

Compares firmonertinib with osimertinib or afatinib in adults with advanced lung cancer

Tests firmonertinib against standard EGFR drugs in adults with advanced lung cancer.

Key facts

Who runs it
Arrivent Biopharma Inc.
Where
Athens, Chaïdári, and Thessaloniki, GreeceSee the 4 sitesAlso in 3 other countries, 17 sites
Registry title
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
Status
Recruiting
Phase
Phase 3
People taking part
36 people, planned
Started
6 Feb 2026
Expected to end
31 Dec 2030
Type of study
Interventional
Record updated
18 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or spread lung cancer (non-small-cell) that has an uncommon EGFR PACC mutation and who have not yet had treatment for it.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Non-small-cell lung cancer that is locally advanced or has spread, and cannot be treated by surgery or radiotherapy meant to remove all of the disease.
Earlier treatment
No earlier anticancer drug treatment for advanced or spread disease, and no earlier treatment with any EGFR-targeting drug. Earlier treatment before the disease spread needs a gap of at least 12 months.
Biomarker or test result
An EGFR PACC mutation shown by local testing of tumor tissue or blood.

Main reasons for not taking part

  • EGFR mutation of exon 19 deletion, L858R or C797S
  • Earlier treatment with an EGFR-targeting drug
  • Earlier anticancer treatment for advanced or spread lung cancer
  • Earlier or active interstitial lung disease or radiation pneumonitis
  • Mean resting corrected QT interval (QTc) above 470 ms

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Greece

Also in 3 other countries, 17 sites

  • Henry Dunant Hospital CenterAthens, GreeceTaking people
  • Thoracic General Hospital of Athens "I Sotiria"Athens, GreeceTaking people
  • University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"Chaïdári, GreeceTaking people
  • Athens Medical Center S.A.Thessaloniki, GreeceTaking people

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
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)
Plain-language title
Compares firmonertinib with osimertinib or afatinib in adults with advanced lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
18 August 2026