Active not recruitingPHASE3INTERVENTIONAL

REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)

This research study, called REZILIENT3, is for people with advanced non-small cell lung cancer that has a particular genetic mutation called an EGFR exon 20 insertion. Doctors are testing a new drug, zipalertinib, alongside standard chemotherapy. The main goal is to find out if this new combination is safe and more effective than chemotherapy alone for people who haven't had previous treatment for this stage of lung cancer. The study will happen in two parts: first, a small group will help find the right dose of zipalertinib to use. Then, a larger group will receive either the new combination or chemotherapy alone to compare their effects. This could offer a new treatment option for this type of lung cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Taiho Oncology, Inc.

Enrolment target

285

Start

18 Dec 2023

Estimated completion

27 May 2027

Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation

What is this study about?

This study, named REZILIENT3, is about finding better treatments for a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for people whose cancer has spread (advanced or metastatic) and has a particular genetic change called an EGFR exon 20 insertion mutation. Having this specific change means that some standard cancer treatments might not work as well, so researchers are always looking for new options.

The study is testing a new medicine called zipalertinib. It's being given in combination with the usual chemotherapy treatments (pemetrexed and platinum-based drugs like carboplatin or cisplatin). The main goal is to see if adding zipalertinib makes the treatment more effective and safer than just having chemotherapy on its own. This is for people who haven't had any previous treatment for their advanced lung cancer.

There are two main parts to the study. In the first small part, doctors will carefully figure out the best dose of zipalertinib to give with chemotherapy. Once that dose is found, the second, larger part of the study will begin. In this part, participants will be randomly chosen to receive either the combined zipalertinib and chemotherapy treatment, or just chemotherapy. This allows doctors to compare the two approaches directly. Some people in the chemotherapy-only group might get a chance to take zipalertinib later if their cancer starts to grow again, which is a common feature in cancer trials.

Key takeaways

Tests a new drug (zipalertinib) for advanced lung cancer with a specific gene change.
Compares zipalertinib + chemotherapy to chemotherapy alone.
For patients who haven't had previous treatment for advanced disease.
Involves regular check-ups and monitoring.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To join this study, you need to be at least 18 years old and have non-small cell lung cancer that has spread (advanced or metastatic) and specifically has an EGFR exon 20 insertion mutation. This is a crucial requirement, and your doctors would need to confirm this through testing. You should also not have received any prior treatment for your advanced lung cancer. However, if you had treatment for earlier-stage lung cancer more than six months ago, or very short-term treatment with certain other targeted drugs that didn't work well, you might still be considered.

There are some key things that might mean you can't join. For example, if you've already had certain other targeted treatments that specifically aim at EGFR exon 20 insertion mutations, you won't be able to participate. Also, doctors will need to review your overall health and medical history to make sure the study treatment is safe for you. Your medical team will help determine if you meet all the necessary criteria.

Quick self-check

Are you 18 years old or older?
Do you have advanced non-small cell lung cancer?
Has your cancer been tested and confirmed to have an EGFR exon 20 insertion mutation?
Have you NOT had any prior treatment for your advanced lung cancer? (Some exceptions may apply)
Are you able to provide an archived tissue sample from your cancer?

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

What does participation involve?

If you join this study, your involvement would be split into two main parts. In the first part, a small number of people will help doctors find the safest and most effective dose of zipalertinib to use with chemotherapy. If you're in the second, larger part, you'll be randomly assigned to one of two groups: either you'll receive zipalertinib plus standard chemotherapy, or you'll receive standard chemotherapy alone. A treatment cycle for both groups lasts 21 days.

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans (like CT scans) to monitor your health and how the treatment is affecting your cancer. These visits are important for keeping you safe and understanding how well the treatment is working. You will continue treatment as long as it is working for you and you are tolerating it well. The total duration of your participation will depend on how your treatment progresses, but your doctors will discuss the expected timeframe with you.

Potential risks and benefits

Taking part in a research study like this offers the potential benefit of accessing a new treatment (zipalertinib) that isn't yet widely available, and it could potentially be more effective than standard chemotherapy alone, especially for your specific type of lung cancer. Your health will be closely monitored by a team of experts. However, like all medicines, zipalertinib and chemotherapy can cause side effects. These can vary from person to person and might include feeling tired, nausea, or other reactions. Your doctors will explain all known potential risks in detail. Remember, joining is completely voluntary, and you can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (130)

Comprehensive Cancer Centers of Nevada - Henderson
Henderson, United States
Comprehensive Cancer Centers of Nevada - Horizon Ridge Henderson
Henderson, United States
Comprehensive Cancer Centers of Nevada - Southeast Henderson - Stephanie
Henderson, United States
Comprehensive Cancer Centers of Nevada - Summerlin Medical Center II
Las Vegas, United States
Comprehensive Cancer Centers of Nevada - Southwest
Las Vegas, United States
Comprehensive Cancer Centers of Nevada - Central Valley - Twain
Las Vegas, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, United States
Gabrail Cancer and Research Center
Canton, United States
University of Texas MD Anderson Cancer Center
Houston, United States
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, Belgium
Algemeen Ziekenhuis Delta - Campus Menen
Menen, Belgium

+118 more sites — see the official record for the full list.

Common questions

What is an EGFR exon 20 insertion mutation?

It's a specific genetic change in your lung cancer that means it might behave differently and respond to certain treatments in a particular way.

What is zipalertinib?

It's a new investigational drug being tested to see if it can help treat lung cancer with the EGFR exon 20 insertion mutation.

Will I definitely get zipalertinib if I join?

Not necessarily. In the main part of the study, participants are randomly assigned to either receive zipalertinib plus chemotherapy or chemotherapy alone.

What is 'standard platinum-based chemotherapy'?

This is a common type of cancer treatment using drugs like pemetrexed and either carboplatin or cisplatin, which are standard for many lung cancers.

Can I stop participating in the study?

Yes, your participation is voluntary, and you can choose to leave the study at any time without it affecting your ongoing medical care.