Active not recruitingPHASE1INTERVENTIONAL

Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

This is an early-stage clinical trial (Phase 1b) for a new medicine called furmonertinib. It's designed for people with advanced non-small cell lung cancer that has spread or can't be cured by surgery or radiotherapy. The study focuses on patients whose cancer has specific genetic changes in the EGFR or HER2 genes, including less common types, and has progressed despite earlier treatments. The main goals are to understand how safe furmonertinib is, how the body handles the drug, and to see if it shows early signs of shrinking cancer. Participants will be treated with furmonertinib, and researchers will carefully monitor their health and the effects of the treatment.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

ArriVent BioPharma, Inc.

Enrolment target

160

Start

30 Jun 2022

Estimated completion

31 Dec 2026

Non-Small Cell Lung Cancer (NSCLC)Metastatic Non-Small Cell Lung Cancer Advanced Non-Small Cell Lung Cancer HER2 Exon 20 Mutations EGFR Exon 20 Mutations EGFR Uncommon Mutations, Including G719X and S768I

What is this study about?

This research study is looking into a new drug called furmonertinib for people with a type of lung cancer known as non-small cell lung cancer (NSCLC). This trial is in its early stages (Phase 1b), which means the main goal is to figure out the best dose of the drug, check its safety, and see if it has any early positive effects on the cancer. The researchers are particularly interested in patients whose lung cancer has spread or is advanced and has specific changes in certain genes, called EGFR or HER2 mutations.

The 'EGFR' and 'HER2' genes play a role in how cancer cells grow. When these genes have certain changes (called mutations), they can cause cancer to develop and grow differently. The current study is focusing on these specific types of lung cancer, including less common variations of these gene changes, especially after other standard treatments have been tried and haven't worked or are no longer effective.

Taking part in this study would involve receiving furmonertinib and being closely monitored by a medical team. The study aims to gather important information that could help develop new treatments for people living with advanced lung cancer that has these specific genetic features.

Key takeaways

This is an early-stage study for a new lung cancer drug, furmonertinib.
It's for advanced non-small cell lung cancer with specific EGFR or HER2 gene changes.
The study aims to understand safety and initial effectiveness of furmonertinib.
Participants must have tried other treatments that didn't work or weren't tolerated.
Close medical monitoring is provided throughout the study.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you would generally need to be an adult (18 years or older) with non-small cell lung cancer that is advanced or has spread. Your cancer must have previously been treated with at least one standard therapy, or your doctors believe that standard treatments are not suitable or haven't worked for you.

Crucially, your cancer must have specific genetic changes called EGFR or HER2 mutations. These mutations need to be confirmed by special tests on your tumor tissue or blood. If your EGFR mutation is one that usually responds to a drug called osimertinib and that drug is available where you live, you would typically have needed to have tried osimertinib first.

Important note: While some patients with cancer that has spread to the brain may be able to join, there are additional specific rules they would need to meet. The study team will review all your medical information carefully to see if this study could be a good fit for you.

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.

Are you 18 years or older?
Do you have advanced non-small cell lung cancer (NSCLC) that has either spread or cannot be treated by surgery/radiotherapy?
Has your cancer progressed after at least one previous standard treatment?
Have tests shown your cancer has specific EGFR or HER2 gene changes (mutations)?
If your EGFR mutation is one that usually responds to osimertinib, have you already tried osimertinib (if it's approved where you live)?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in this study, you would receive the study drug, furmonertinib. The study has two main parts: an initial 'dose escalation' stage where different doses are tested to find the safest and most effective, and then a 'dose expansion' stage where more patients receive the chosen dose. You would be assigned to one of these stages.

Perticipation involves regular visits to the clinic for assessments. These will include physical examinations, blood tests, and scans (like CT scans) to monitor your health and how the cancer is responding to the treatment. The researchers will also be looking at how your body processes the drug. The exact number of visits and tests will depend on which stage of the study you are in and your individual response. The total duration of your participation would involve taking the study drug for as long as it benefits you and is safe, followed by a period of follow-up monitoring.

Potential risks and benefits

Participating in a clinical trial like this offers the potential benefit of accessing a new treatment (furmonertinib) that is not yet widely available, which might help control your cancer. However, as furmonertinib is still under investigation, there are potential risks and side effects that are not yet fully known. You will be closely monitored for any adverse effects, and the medical team will explain all known risks to you before you decide to take part. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (42)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

ArriVent Investigative Site
Verified postcode
Prescott, United States
ArriVent Investigative Site
Verified postcode
Sacramento, United States
ArriVent Investigative Site
Verified postcode
Whittier, United States
ArriVent Investigative Site
Verified postcode
Celebration, United States
ArriVent Investigative Site
Verified postcode
Detroit, United States
ArriVent Investigative Site
Verified postcode
Houston, United States
ArriVent Investigative Site
Verified postcode
Fairfax, United States
ArriVent Investigative Site
Verified postcode
Blacktown, Australia
ArriVent Investigative Site
Verified postcode
St Leonards, Australia
ArriVent Investigative Site
Verified postcode
Heidelberg, Australia
Arrivent Investigative Site
Verified postcode
Edmonton, Canada
Arrivent Investigative Site
Verified postcode
Toronto, Canada

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. 'Non-small cell' refers to how the cancer cells look under a microscope.

What are EGFR or HER2 mutations?

These are specific changes in the genes of your cancer cells that can make the cancer grow. Some treatments specifically target these changes.

What does 'advanced or metastatic' mean?

It means the cancer has either grown locally into surrounding tissues or has spread to other parts of the body.

What is a 'Phase 1b' study?

This is an early stage of clinical research where the main goals are to find a safe dose of a new drug, understand how the body handles it, and see if there are any early signs it helps treat the cancer.

Can I join if I've had previous treatments?

Yes, this study is specifically for patients whose cancer has progressed after at least one standard treatment, or for whom standard treatments haven't worked well.