Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase Ib/II, Multi-Center, Open-Label Study to Evaluate the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH925 in Combination with Cetuximab in Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

This research is a 'Phase I and II' study, which means it’s still in the early stages of testing. It's for people with advanced non-small cell lung cancer that hasn’t been treated yet and has a specific gene change called 'KRAS G12C mutation'. The study is looking at a new combination of two medicines, one called Erbitux and the other referred to as Fulzerasib. Doctors want to find out how safe these drugs are together, what side effects they might cause, how the body handles them, and how well they shrink the cancer or slow its growth. This is an open-label study, meaning both patients and doctors will know which treatment is being given.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Zhejiang Genfleet Therapeutics Co. Ltd.

Enrolment target

Start

23 Feb 2023

Previously Untreated Advanced NSCLC Harboring KRAS G12C Mutation

What is this study about?

This study is investigating a new way to treat a specific type of advanced lung cancer called Non-Small Cell Lung Cancer (NSCLC). This particular cancer has a special genetic change, or 'mutation,' called KRAS G12C. This study is for people who haven't had any treatment for their advanced lung cancer yet.

The research is looking at a combination of two drugs: Erbitux (which is a well-known cancer drug) and a new drug called Fulzerasib. The doctors want to understand several things: first, how safe this combination is and what side effects people might experience. They'll also be checking how the drugs move through the body and how quickly they are processed. Most importantly, they want to see if the combination treatment can shrink the cancer or stop it from growing.

This study is a 'Phase I and II' trial. Phase I studies are usually the first time a new drug is tested in people, focusing on safety and finding the right dose. Phase II studies then check if the drug works well against the cancer. By combining these phases, researchers can get information on both safety and effectiveness more efficiently. This research is really important because it could lead to new and better treatment options for this specific type of lung cancer, offering hope to patients.

Key takeaways

This study is for a specific type of advanced lung cancer with a KRAS G12C gene change.
It tests a new combination of two drugs that hasn't been used before for this condition.
The main goals are to check the new treatment's safety and how well it works.
It's an early-stage clinical trial (Phase I/II), meaning it's still being investigated.
You must have had no previous treatment for your advanced lung cancer to be eligible.

Who may be eligible?

To join this study, people must have a specific type of advanced lung cancer called non-small cell lung cancer, and it must have a particular gene change known as the KRAS G12C mutation. This means your cancer cells have a specific genetic fault that the new treatment aims to target.

Critically, you must not have received any previous treatment for your advanced lung cancer. This study is specifically for newly diagnosed or untreated advanced cases. You also need to be at least 18 years old, and the study is open to both men and women.

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.

Do I have advanced non-small cell lung cancer?
Has my cancer been tested and found to have the 'KRAS G12C mutation'?
Have I received no previous treatment for my advanced lung cancer?
Am I 18 years old or older?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive a combination of two medicines: Erbitux, which is given as a drip into your vein (an infusion), and the new drug, Fulzerasib. The doctors and nurses will closely monitor your health throughout the study.

This will involve regular visits to the clinic where you'll have various checks. These include blood tests to look at your general health and how the drugs are working, measurements of your vital signs (like blood pressure and heart rate), physical examinations, and heart rhythm tests called ECGs. They will also assess how your cancer is responding to the treatment, which may involve scans or other procedures. These assessments are important to track any side effects and to see how effective the treatment is. The total duration of your participation will depend on how you respond to the treatment and the study plan, but it will involve ongoing monitoring and follow-up.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new treatment before it's widely available, and dedicated medical care and monitoring. For patients with this type of lung cancer, this study could potentially slow down the cancer's growth or even shrink it. However, because this is an early-stage study, there are also risks. The new drug combination may cause side effects, some of which could be severe or unexpected. The treatment might not work for everyone, and it might not be better than existing treatments. We don't make medical recommendations, and it's essential to discuss all potential risks and benefits with your doctor. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (4)

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

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Unverified
Italy
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Unverified
Spain
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Unverified
France
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Unverified
Greece

Common questions

What does 'advanced non-small cell lung cancer' mean?

It means the lung cancer has spread beyond the lung where it started and needs treatment that affects the whole body.

What is a 'KRAS G12C mutation'?

It's a specific change in a gene in the cancer cells that can make them grow. This study targets cancers with this particular change.

What are 'Phase I and II' studies?

These are early research stages. Phase I checks safety and dosage, while Phase II starts looking at how well the treatment works.

Will I know if I'm getting the new drug?

Yes, this is an 'open-label' study, so you and your doctor will know you are receiving the study treatments.

What is Erbitux?

Erbitux is a type of cancer drug that works by blocking signals that cancer cells use to grow. It is already approved for some cancers.