RecruitingPHASE2INTERVENTIONAL

A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

This study is testing a new drug called zipalertinib for people with advanced non-small cell lung cancer (NSCLC). This specific type of lung cancer has certain changes in a gene called EGFR, specifically 'Exon 20 insertions' or other less common gene changes. Researchers want to understand how safe zipalertinib is, how well it works, and how it moves through the body. The study also includes smaller parts looking at how zipalertinib might interact with other medicines and finding the best dose. Various groups of patients will take part, including those who’ve had previous treatments and those who haven't. The goal is to find better treatment options for this type of lung cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Taiho Oncology, Inc.

Enrolment target

220

Start

31 Jul 2023

Estimated completion

31 Dec 2028

Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

What is this study about?

This study is focused on a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has spread or is advanced. What makes this study unique is that it's for people whose cancer has particular faulty genes. These gene faults are often called 'mutations' and in this case, they involve the Epidermal Growth Factor Receptor (EGFR) gene, specifically 'Exon 20 insertions' or other less common changes.

The new drug being tested is called zipalertinib. The main purpose of the study is to find out if zipalertinib is safe for people to take, how well it helps to treat the cancer, and how the body handles the drug. This information is really important because it could lead to new and better ways to treat this particular type of lung cancer.

The study also includes smaller parts. For example, some people will help researchers understand if zipalertinib affects how other medicines work. Another part of the study will help find the best dose of zipalertinib. Patients will be grouped based on their previous treatments or whether their cancer has spread to the brain. This helps researchers understand how zipalertinib works for different patient needs.

Key takeaways

This study is testing a new drug, zipalertinib, for advanced non-small cell lung cancer.
It's for people with specific gene changes (EGFR Exon 20 insertions or other uncommon mutations).
The study aims to understand the drug's safety, effectiveness, and how it works in the body.
Different patient groups will participate, depending on their prior treatments and cancer status.
Participation involves taking the study drug and having regular check-ups and tests.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have advanced non-small cell lung cancer that has been confirmed by a doctor. Your cancer must also have a specific gene fault called an 'EGFR Exon 20 insertion' or another less common EGFR gene change. This will be checked by a lab test.

Depending on your specific situation, there are different groups within the study. For example, some groups are for people who have already had certain treatments for their lung cancer, while others are for those who haven't. If your cancer has spread to your brain, you might still be able to join if your condition is stable and you've had treatment for it.

It's very important to discuss your full medical history with the study team. They will carefully check if this study is suitable and safe for you to join based on all the detailed rules. They will also make sure you understand everything before you make a decision.

Quick self-check

Are you at least 18 years old?
Do you have non-small cell lung cancer that is advanced or has spread?
Has your cancer been tested and confirmed to have an EGFR Exon 20 insertion or another uncommon EGFR mutation?
Are you comfortable with regular hospital visits and tests?
Have you discussed your brain scan results with your doctor if your cancer has spread to the brain?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Taking part in this study would involve regular hospital or clinic visits for check-ups, scans, and blood tests to see how you are responding to the medication and to monitor for any side effects. You would receive the study drug, zipalertinib, which is taken as a pill. The exact schedule for taking the medication and how often you'd need to visit will be explained by the study team.

Some parts of the study might also involve specific tests to see how the drug interacts with other medicines or to find the best dose. The total length of your participation would depend on your response to the treatment and the specific study group you are in, but it could involve ongoing treatment and follow-up appointments for a significant period. You'll have close medical supervision throughout.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. You might benefit from receiving a new treatment that isn't widely available yet, which could help your cancer. However, there's no guarantee that the drug will work for you, and like all medications, zipalertinib may cause side effects, which the study team will discuss in detail. Your safety is the top priority, and you'll be closely monitored for any issues. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (80)

University of Alabama at Birmingham
Birmingham, United States· Withdrawn
City of Hope - Duarte
Duarte, United States· Recruiting
Beth Israel Deaconess Medical Center
Boston, United States· Recruiting
Comprehensive Cancer Centers of Nevada - Central Valley - Twain
Las Vegas, United States· Recruiting
Memorial Sloan Kettering Cancer Center - Basking Ridge
Basking Ridge, United States· Recruiting
Memorial Sloan Kettering Cancer Center - Monmouth
Middletown, United States· Recruiting
Memorial Sloan Kettering Cancer Center - Bergen
Montvale, United States· Recruiting
Memorial Sloan Kettering Cancer Center - Commack
Commack, United States· Recruiting
Memorial Sloan Kettering Cancer Center - Westchester
Harrison, United States· Recruiting
MSK Cancer Center
Long Island City, United States· Recruiting
Memorial Sloan Kettering Cancer Center - Nassau
Uniondale, United States· Recruiting
Gabrail Cancer and Research Center
Canton, United States· Recruiting

+68 more sites — see the official record for the full list.

Common questions

What is EGFR Exon 20 insertion?

It's a specific change (mutation) in a gene in some lung cancer cells that can make the cancer grow.

Is zipalertinib available outside this study?

No, it's an experimental drug, meaning it's only available to people taking part in this clinical trial right now.

What does 'locally advanced or metastatic' mean?

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

Will I get a placebo (dummy drug)?

The information provided suggests all participants will receive zipalertinib, not a placebo. This is a Phase 2 study focused on safety and effectiveness.

How long will the drug interaction part of the study take?

If you're in that specific group, it would involve taking a single dose of certain medicines along with zipalertinib to see how they interact.

How to find out more

Taiho Oncology, INC

medicalinformation@taihooncology.com +1 844-878-2446 Official trial record

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