At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Firmonertinib (drug), EGFR-TKI inhibitor based on investigator's choice (drug)
- How long the study runs
- Study runs about 60 months (dates as stated)
- About the drug or intervention
- Firmonertinib — drug: 240 mg oral, daily firmonertinib tablet · EGFR-TKI inhibitor based on investigator's choice — drug: osimertinib 80 mg oral, daily tablet OR afatinib 40 mg oral, daily tablet
- Patient visit burden
- Not specified by the sponsor
In plain English
This study tests a drug called firmonertinib in people with a type of lung cancer called non-small-cell lung cancer (NSCLC) that has spread or cannot be removed with surgery or radiotherapy. It also has a change (mutation) in a gene called EGFR, known as a PACC uncommon mutation. Firmonertinib will be compared with a treatment chosen by the study doctor from a group of cancer drugs that target EGFR. This is the first treatment of this kind participants will have had for advanced or spread lung cancer.
Who can take part
- Lung cancer (non-small-cell lung cancer) that is locally advanced or has spread, and cannot be cured with surgery or radiotherapy
- A test showing an EGFR PACC mutation in tumour tissue or blood
- No previous whole-body cancer treatment for advanced or spread lung cancer, including any EGFR-targeting drugs
- If you had chemotherapy, immunotherapy, or chemoradiotherapy earlier for non-spread disease, you must have had at least 12 months without treatment since then
- Cancer that has spread to the brain is allowed if it is not causing symptoms
Who may not be able to
- Not stated — ask the trial team
What taking part involves
- • Taking firmonertinib, or a doctor-chosen EGFR-targeting cancer drug, as the first treatment for this cancer
- • Not stated — ask the trial team
Time commitment: Visits, duration and what taking part involves: not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 480
- Started
- 2025-12-17
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for non-small-cell lung cancer
- • Phase3 - 480 participants
- • Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-small-cell lung cancer
Where?
- • London - University College London Hospitals NHS Foundation Trust
- • Manchester - The Christie NHS Foundation Trust
- • London - The Royal Marsden NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ any Epidermal Growth Fact
- ✓ experienced a treatment free interval of at least 12 months
What the study is looking for
- ✓Key Eligibility Criteria:
- ✓Histologically or cytologically documented, that has grown locally or that has spread Non-Small Cell Lung Cancer (NSCLC) not...
- ✓Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or...
- ✓Patients with not causing symptoms CNS metastases are eligible.
See the full criteria
Where Is This Study? (3 UK sites)
University College London Hospitals NHS Foundation Trust
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
How to Get in Touch
Clinical Trials
Sponsor contactCONTACT