ALPACCA
Research type
Research Study
Full 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 NONSMALL-CELL LUNG CANCER WITH EPIDERMAL GROWTH FACTOR RECEPTOR P-LOOP AND ALPHA C-HELIX COMPRESSING (PACC) UNCOMMON MUTATIONS (ALPACCA)
IRAS ID
1012548
Contact name
Steven Yea
Contact email
Sponsor organisation
ArriVent Biopharma, Inc.
Clinicaltrials.gov Identifier
Research summary
A drug called firmonertinib is being developed for the treatment of NSCLC with mutations in EGFR with a specific change in the P-loop and alpha C-helix compressing (PACC) region. These changes in EGFR PACC can cause lung cancer to grow more rapidly.
Drugs like firmonertinib, osimertinib, and afatinib are called EGFR inhibitors (also known as tyrosine kinase inhibitors [TKIs]); they can help turn off the overactive EGFR gene and slow cancer growth in many people with EGFR mutations.
The purpose of the study is to learn about the effectiveness and safety of firmonertinib and to compare the effects, good or bad, with those of osimertinib or afatinib.
About 480 participants will be enrolled in total. Participants will be randomized to 1 of 2 groups, and will receive firmonertinib, or investigator’s choice of osimertinib or afatinib. The study is “open-label” which means that participants will know which investigational study treatment they are receiving.
This study has 3 parts: Screening, Treatment and Follow-up. Screening will take around 4 weeks. The Treatment period will continue until participants choose to withdraw from the study, their lung cancer worsens, or the study doctor determines that there is an increased risk of side effects if they continue treatment. The Follow-up period includes follow up visits or calls approximately every 6 weeks or 3 months.
The study medications are all administered as tablets, which participants can take at home. Participants will also be required to complete a dosing diary every day, to confirm details of their taken dosages.
The study also involves procedures such as: blood and urine sample collection, questionnaire completion, vital signs, physical examinations, electrocardiograms (ECGs), eye examinations, cardiac health scans, radiological scans (such as CT, MRI, bone scan or PET scan). A tumour biopsy sample may also be collected.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0173
Date of REC Opinion
6 Nov 2025
REC opinion
Further Information Favourable Opinion