Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2 Study of TAS3351 in Patients with Advanced Non-Small Cell Lung Cancer and EGFR Mutations

This research study is looking at a new drug, TAS3351, for people diagnosed with advanced non-small cell lung cancer. This particular study focuses on patients whose cancer has a specific genetic change (called an EGFR mutation) which has developed resistance to earlier treatments. The study is split into two main parts: Phase 1 and Phase 2. In Phase 1, the main goal is to find a safe dose of TAS3351 and understand any side effects. In Phase 2, the researchers will mainly focus on how well the drug shrinks or stops the cancer from growing. They will also continue to monitor for side effects and check the overall health and quality of life of participants. All participants will be adults, aged 18 or older, regardless of gender.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Taiho Oncology Inc.

Enrolment target

Start

05 Jul 2023

Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring an acquired C797S epidermal growth factor receptor (EGFR) mutation.

What is this study about?

This study is investigating a new medicine called TAS3351 for individuals with a specific type of advanced lung cancer. This cancer is known as non-small cell lung cancer (NSCLC), and it has a particular genetic change called an EGFR mutation. Some patients whose cancer initially responds to treatments targeting this EGFR mutation can later find that their cancer becomes resistant, often due to a new mutation called C797S. This study is specifically for these patients, aiming to see if TAS3351 can be an effective treatment option.

The study has two phases: Phase 1 and Phase 2. The first phase, called Phase 1, is crucial for understanding the new medicine. Researchers will start with a small dose and gradually increase it, carefully watching for any side effects and to find the highest dose that is safe to give. They will also look at how the body handles the medicine and get an early idea of whether it shows any signs of working against the cancer.

In the second phase, Phase 2, more patients will receive the chosen dose of TAS3351. The main goal here is to see how well the medicine works at shrinking the cancer or stopping it from growing. Researchers will use body scans to measure any changes in the tumours. They will also continue to closely monitor for any side effects and assess the overall health and well-being of the participants throughout the study. This helps them understand both the benefits and risks of the new medicine.

Key takeaways

This study is for advanced non-small cell lung cancer.
It targets a specific genetic change (EGFR C797S mutation) in the cancer.
A new medicine, TAS3351, is being tested.
The study aims to check safety and how well the medicine works.
It involves regular monitoring and clinic visits.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. The study is open to both men and women.

Critically, you must have advanced non-small cell lung cancer. This means the cancer has spread locally or to other parts of your body. Your cancer also needs to have a specific genetic change called an EGFR mutation, and importantly, it must also have developed a resistance mutation called C797S, which means previous treatments targeting EGFR may no longer be working.

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 old or older?
Do you have advanced non-small cell lung cancer?
Does your cancer have an EGFR mutation?
Does your cancer also have the C797S resistance mutation?
Have you been told your cancer is locally advanced or has spread (metastatic)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will receive the study medicine, TAS3351. The study involves regular visits to the clinic for medical check-ups, blood tests, and scans (like CT scans) to monitor your health and how the medicine is affecting your cancer. Doctors and nurses will carefully check for any side effects and ask about your general well-being.

In the early part of the study (Phase 1), the number of tablets you take might change as doctors work out the best and safest dose. In the later part (Phase 2), you'll receive a set dose. The total length of your participation will depend on how you respond to the treatment and your overall health, but you will continue treatment as long as it is working and you are tolerating it well. There will also be follow-up appointments after you stop taking the medicine to keep track of your health.

Potential risks and benefits

Like all medicines, TAS3351 might have side effects, and some could be serious. The research team will explain all known or possible risks and monitor you very closely throughout the study. There's no guarantee that the medicine will work for your cancer, but it could offer a new treatment option where others haven't been effective. We hope to better understand how this new medicine works and the best ways to use it. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

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

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Unverified
France
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Unverified
Netherlands
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Unverified
Germany
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Unverified
Spain
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Unverified
Italy

Common questions

What kind of lung cancer is this study for?

This study is for a specific type of advanced non-small cell lung cancer that has particular genetic changes (EGFR and C797S mutations).

What is the new medicine called?

The new medicine being tested in this study is called TAS3351.

Why are there two phases to the study?

Phase 1 is mainly to find a safe dose and look at side effects. Phase 2 then focuses on how well the medicine works against the cancer at that safe dose.

Will I know if the medicine is working for me?

Yes, the doctors will regularly check your cancer with scans and blood tests, and they will discuss your progress with you.

Can I stop taking part in the study?

Yes, you can choose to stop participating in the study at any time, and this will not affect your future medical care.