Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Precision Immuno-Oncology for advanced Non-small cell lung cancer patients with PD-1 ICI Resistance (PIONeeR clinical study)

This research, called the PIONeeR study, is looking for better ways to treat advanced non-small cell lung cancer, especially when first-line immune-boosting treatments haven't worked well or have stopped working. It's a Phase II study, meaning it's testing different new drug combinations to see if they are safe and effective. Participants will try different combinations of medicines including AZD6738, Savolitinib, Ceralasertib, DURVALUMAB, Monalizumab, Oleclumab, and sometimes DOCETAXEL. The main goal is to find out how many people have their cancer controlled (meaning it stops growing or shrinks) after 12 weeks of treatment. Researchers will also look at how long people live without their cancer getting worse and how many experience their cancer shrinking or disappearing. This study is for adults aged 18 and older.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Centre Hospitalier Regional De Marseille

Enrolment target

130

Start

25 Sep 2024

non small cell lung cancer

What is this study about?

This study, called PIONeeR, is focusing on a type of cancer treatment called immuno-oncology, which helps your body's own immune system fight cancer. Specifically, it's for people with advanced non-small cell lung cancer (NSCLC) where previous immune-boosting treatments (often called PD-1 ICI) have stopped working or weren't effective.

Imagine your cancer has been treated with medicines designed to boost your immune system, but it's no longer responding. This study is testing combinations of newer medications to see if they can overcome this resistance and help control the cancer. They want to find out if these new approaches can stop the cancer from growing or even make it shrink.

Researchers are testing several different drug mixtures. These include medicines like AZD6738, Savolitinib, Ceralasertib, DURVALUMAB, Monalizumab, Oleclumab, and in some cases, an established chemotherapy drug called DOCETAXEL. The main aim is to see how many people in each treatment group have their cancer successfully controlled (meaning it either shrinks or doesn't get worse) after 12 weeks. They will also look at how long people live without their cancer getting worse and how many experience their cancer shrinking or disappearing completely.

Key takeaways

This study is for advanced non-small cell lung cancer.
It's for patients whose cancer is no longer responding to standard immunotherapy.
It tests new combinations of drugs to try and control the cancer.
The main goal is to see if the cancer stops growing or shrinks after 12 weeks.
It's a Phase II study, looking at safety and effectiveness.

Who may be eligible?

This study is open to adults aged 18 and over, of any gender. The most important requirement is that you have advanced non-small cell lung cancer.

Crucially, your lung cancer must have previously been treated with a type of immune-boosting medicine (often called PD-1 therapy) but has either not responded well to it, or has responded, but then started to get worse again. This study is specifically looking for people whose cancer has become resistant to these immunotherapy treatments.

There will be other health checks to make sure you are well enough to take part and that these treatments are safe for you. This will likely involve reviewing your medical history, current health, and other conditions you might have.

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?
Have you been diagnosed with advanced non-small cell lung cancer?
Has your cancer stopped responding to a previous immune-boosting treatment (like PD-1 therapy)?
Are you able to attend regular hospital appointments for tests and treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to one of several treatment groups, each receiving a different combination of the study medications. You will take these medications, which might be given as an injection, through a drip (infusion), or as tablets, depending on the specific drug combination you receive.

You'll have regular hospital visits for check-ups, scans to monitor your cancer, and blood tests. These visits are important for the research team to see how you're responding to the treatment and to keep an eye on your overall health and any side effects. The study will look at your progress over at least 12 weeks to see if your cancer is controlled. You will continue to be monitored after this initial period to track your progress and any long-term effects of the treatments. The total duration of your participation will depend on how you respond to the treatment and the study's follow-up plan for your specific group.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as gaining access to new treatments that are not yet widely available, and helping doctors learn more about how to treat advanced lung cancer, which could help future patients. However, there's no guarantee that the treatment will be effective for you, and like all medications, the study drugs carry potential risks of side effects. These can vary depending on the specific combination of drugs and will be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is 'non-small cell lung cancer'?

It's the most common type of lung cancer, and there are different ways it can be treated depending on its stage and characteristics.

What does 'PD-1 ICI Resistance' mean?

This means your cancer has stopped responding or never responded well to a type of immune-boosting treatment that targets something called PD-1.

What is a Phase II study?

In a Phase II study, new treatments are tested on a larger group of people to see if they are safe and effective, after preliminary safety tests have been done.

What is 'Disease Control Rate'?

This is a measure of how many people taking part in the study have their cancer stop growing or shrink after treatment.

Will I know which treatment I'm getting?

Yes, unlike some studies, you will know which specific combination of study drugs you are receiving.