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Clinical Trials in the EU / 2025-522151-26-00
Completed Phase III

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)

2025-522151-26-00 · tracked via the Priya Life Science EU tracker
Sponsor
Arrivent Biopharma Inc.
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
10/12/2025
Enrollment target
36
Sites
Greece, France, Spain, Italy

Condition studied

Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations

Investigational medicinal product(s)

OSIMERTINIBAFATINIBFurmonertinibOSIMERTINIBAFATINIBAFATINIB

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

1. Progression Free Survival (PFS) determined by blinded independent central review (BICR), 2. Confirmed overall response rate (ORR) as determined by BICR

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522151-26-00 on CTIS ↗ ← All trials in the EU