AuthorisedPhase II and Phase III (Integrated)Interventional

A Biomarker-Directed, Multi-Centre Phase II/III Study of ctDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer - BR.36

This research study, called BR.36, is for people with advanced lung cancer that has spread to other parts of the body. The main goal is to find out if using blood tests to track tiny bits of cancer DNA (called ctDNA) can help doctors decide which combination of existing treatments works best for each patient. These treatments include chemotherapy drugs like Abraxane, Cisplatin, Carboplatin, Paclitaxel, and Pemetrexed, along with immunotherapy drug Pembrolizumab. By tailoring the treatment based on these blood tests, researchers hope to stop the cancer from growing for longer and help people live longer, healthier lives. The study is also checking how practical and easy these new approaches are to use.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

IRCCS Istituto Nazionale Tumori Fondazione Pascale

Enrolment target

Start

13 Jan 2026

metastatic NSCLC patients

What is this study about?

This study, known as BR.36, is exploring new and potentially more effective ways to treat a type of advanced lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of the body. Currently, there are several treatments available, including chemotherapy and immunotherapy, which uses your body's own immune system to fight cancer. This study is trying to understand if we can use a special blood test to guide these treatments better.

The special blood test looks for tiny pieces of cancer DNA in your blood, called circulating tumour DNA (ctDNA). Researchers believe that by regularly checking these ctDNA levels, they might be able to see how well a treatment is working much earlier. This could help doctors decide if a treatment should be continued or changed, aiming to give you the most effective care for your specific cancer.

The main aims of this study are to see if using these blood tests to guide treatment can stop the cancer from growing for longer periods and help people live longer overall. They will also look at how practical it is for doctors to use this approach in their regular practice. The hope is that this research will lead to more personalised and successful treatments for people with advanced lung cancer.

Key takeaways

This study is for advanced lung cancer (NSCLC) that has spread.
It's testing if blood tests can guide cancer treatment.
It uses a combination of chemotherapy and immunotherapy.
Hopes to stop cancer growth for longer and improve survival.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

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

The study is specifically looking for people who have a type of lung cancer called non-small cell lung cancer (NSCLC) that has spread to other parts of your body, meaning it is considered advanced or metastatic.

There might be other specific health requirements or conditions that you need to meet, or things that would prevent you from joining. These details would be discussed with you by the study team and your doctor.

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 non-small cell lung cancer (NSCLC)?
Has your lung cancer spread to other parts of your body?
Are you able to visit a hospital or clinic for regular appointments and treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a combination of current cancer treatments. These include various chemotherapy drugs such as Abraxane, Cisplatin, Carboplatin, Paclitaxel, or Pemetrexed, potentially combined with an immunotherapy drug called Pembrolizumab. The specific treatment plan would be based on your individual needs and the results of your ctDNA blood tests.

Throughout the study, you would have regular visits to the clinic for your treatments, blood tests (including the ctDNA test), and other assessments to monitor your health and how the treatment is working. The study team will track how long the cancer stays stable without growing and how you are doing overall.

We don't have a total duration here, but studies like this typically involve treatments spaced out over several months, followed by a period of follow-up to see the long-term effects. The study team will explain the full schedule and commitment if you are interested.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving carefully monitored, personalised treatment tailored to your cancer's response, potentially leading to better outcomes than standard care. However, like all medical treatments, there are potential risks, including side effects from the chemotherapy and immunotherapy drugs. These side effects can vary from person to person. The research team will explain all known and potential risks in detail, and your safety will be closely monitored throughout the study. Remember, taking part in a clinical trial is always voluntary, and you are free to withdraw from the study at any time without affecting your future 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
Italy

Common questions

What is advanced non-small cell lung cancer (NSCLC)?

It's a type of lung cancer where the cells are not small, and it has spread from the lung to other parts of your body.

What is 'ctDNA'?

CtDNA stands for 'circulating tumour DNA'. It's tiny bits of cancer's genetic material that can be found in your blood.

What is 'immunotherapy'?

Immunotherapy is a treatment that helps your body's own immune system fight cancer cells more effectively.

What are chemotherapy drugs?

These are powerful medicines designed to kill cancer cells or slow their growth.

Will I definitely get a new treatment?

This study uses existing treatments, but it's testing a new way of deciding which one to use based on your blood tests, aiming for better results.