RecruitingPHASE3INTERVENTIONAL

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

This research study is looking at a new medicine called firmonertinib for people with advanced non-small cell lung cancer. This type of lung cancer has specific genetic changes, sometimes called 'uncommon EGFR mutations' or 'PACC mutations'. The study aims to see how well firmonertinib works compared to standard treatments like osimertinib or afatinib, which are currently used for similar conditions. It also checks for any side effects. Patients in the study will be randomly assigned to receive firmonertinib or one of the standard treatments, and they haven't had previous treatment for their advanced cancer. The goal is to find out if firmonertinib is a better or safer option for these patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

ArriVent BioPharma, Inc.

Enrolment target

480

Start

17 Dec 2025

Estimated completion

01 Dec 2030

Non-Small-Cell Lung Cancer Metastatic Non-Small-Cell Lung Cancer Advanced Non-Small-Cell Lung Cancer EGFR P-Loop and Alpha C-Helix Compressing EGFR PACC EGFR Uncommon Mutations

What is this study about?

This study is a clinical trial, which means it's a carefully planned medical research project involving real patients. The main goal is to find better ways to treat a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for people whose NSCLC has certain genetic changes, known as 'EGFR PACC mutations' or 'uncommon EGFR mutations'. These mutations can make cancer cells grow more quickly, and some medicines are designed to target them. The study is comparing a new medication called firmonertinib with two established treatments, osimertinib and afatinib.

Researchers want to see if firmonertinib is more effective at controlling the cancer or has fewer side effects than the current treatments. All participants are newly diagnosed with advanced or metastatic NSCLC (meaning the cancer has spread) and haven't had other treatments for their advanced cancer yet. This research is important because it could lead to new or improved treatment options for people living with this specific type of lung cancer, potentially offering them a better quality of life and improved outcomes.

The study is 'Phase 3', which is usually the last step before a new drug might be approved for wider use. It's also 'global', meaning it's happening in many different locations around the world, and 'open-label', which means both the patient and the doctors will know which treatment is being given.

Key takeaways

This study is testing a new drug for advanced non-small cell lung cancer with specific genetic changes.
It compares the new drug (firmonertinib) with existing treatments (osimertinib or afatinib).
You must not have had previous treatment for your advanced cancer to join.
The study aims to find out if the new drug is more effective and safe.
You will be closely monitored by a medical team throughout the study.

Who may be eligible?

To join this study, your doctors need to have confirmed that you have a type of lung cancer called non-small cell lung cancer (NSCLC) that's either locally advanced (meaning it's grown into nearby areas) or has spread to other parts of your body (metastatic). It also means that surgery or radiotherapy aren't suitable options for a complete cure.

Crucially, your cancer must have specific genetic changes called 'EGFR PACC mutations'. These mutations need to be found in tests of your cancer tissue or blood. You also must not have received any previous medication for your advanced or metastatic lung cancer. However, if you had chemotherapy, immunotherapy, or radiotherapy for earlier, non-spreading cancer, you might still be able to join if it's been at least 12 months since that treatment ended. People with brain metastases (cancer that has spread to the brain) can also take part, as long as these haven't caused any symptoms.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with locally advanced or metastatic non-small cell lung cancer (NSCLC)?
Have tests confirmed that my cancer has 'EGFR PACC mutations'?
Have I NOT had any other drug treatments for my advanced or metastatic lung cancer yet?
If I had chemotherapy/immunotherapy/radiotherapy before for non-spreading cancer, was it more than 12 months ago?
Are any brain metastases I might have causing no symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups: one group will receive the new medicine, firmonertinib (240 mg), and the other group will receive either osimertinib (80 mg) or afatinib (40 mg). The choice between osimertinib and afatinib for the second group will be made by your doctor. You will take your assigned medication as a tablet by mouth once a day. Neither you nor your doctor will know which specific treatment you are getting. The study involves regular visits to the clinic for check-ups, blood tests, and scans to monitor how you're responding to the treatment and to check for any side effects. The exact number of visits and their frequency will be explained by the study team, but throughout the study, your health will be closely monitored. This continues for as long as the treatment is helping and deemed safe, followed by a period of careful follow-up.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing a new treatment that might be more effective than existing options, or it could lead to better understanding and improved treatments for others in the future. However, there are also potential risks involved. The new drug, firmonertinib, may cause side effects, some of which could be serious, just like any medication. The current treatments, osimertinib and afatinib, also have known side effects. The study team will closely monitor you for any adverse effects and will explain these risks in detail. Remember, deciding whether to participate is entirely your choice, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (78)

USC/Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
University of California Davis Comprehensive Cancer Center
Verified postcode
Sacramento, United States· Recruiting
UCSF Medical Center-Mission Bay
Verified postcode
San Francisco, United States· Recruiting
Kaiser Permanente Medical Center
Verified postcode
Vallejo, United States· Recruiting
University of Colorado Health
Verified postcode
Aurora, United States· Recruiting
Illinois Cancer Specialists
Verified postcode
Arlington Heights, United States· Recruiting
University of Illinois Hospital and Health Sciences Systems
Verified postcode
Chicago, United States· Recruiting
Northwell Health/R.J. Zuckerberg Cancer Center
Verified postcode
Lake Success, United States· Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
Verified postcode
New York, United States· Recruiting
Ohio State University Hospitals
Verified postcode
Columbus, United States· Recruiting
Fox Chase Cancer Center
Verified postcode
Philadelphia, United States· Recruiting
Texas Oncology
Verified postcode
Dallas, United States· Recruiting

Common questions

What are 'uncommon EGFR mutations'?

EGFR mutations are changes in the genetic code of your cancer cells. 'Uncommon' just means they are less frequent than other types of EGFR mutations, but they can still be targeted by specific medicines like the ones in this study.

What does 'first-line treatment' mean?

First-line treatment means that this is the first medicine you would receive for your advanced or metastatic lung cancer. You haven't received other treatments for this stage of your cancer before.

Will I know which drug I'm taking?

Yes, in this specific study, both you and your doctor will know whether you are receiving firmonertinib or one of the comparison drugs (osimertinib or afatinib). This is called an 'open-label' study.

What happens if the drug doesn't work for me?

Your doctors will closely monitor how you respond to the treatment. If the treatment isn't working or if you experience significant side effects, you will discuss other treatment options with your medical team, and you can stop participating in the study.

Who is paying for this study?

Clinical trials are typically funded by pharmaceutical companies, government health organisations, or charitable foundations. The company developing firmonertinib is sponsoring this study.

How to find out more

Vanessa Esquibel

furmo006ct@arrivent.com 619-540-3451 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.