Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A randomized phase II study of neo-adjuvant chemo/immunotherapy versus chemo-therapy alone for the treatment of locally advanced and potentially resectable non-small cell lung cancer (NSCLC) patients_NADIM II

This study, called NADIM II, is researching a new approach for treating certain types of advanced lung cancer (non-small cell lung cancer) that can still be removed by surgery. It aims to see if combining a special immune-boosting drug, OPDIVO, with standard chemotherapy before the operation leads to better outcomes than just chemotherapy alone. The main goal is to find out if this combination can shrink the cancer more effectively before surgery. Researchers will also look at how long people live, how long they stay free of cancer, surgery details, and any side effects. This study could help doctors understand the best way to treat this kind of lung cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fundacion GECP

Enrolment target

Start

10 Jun 2024

Non-small cell lung cancer (NSCLC)

What is this study about?

This study, named NADIM II, is looking into a new treatment approach for a type of lung cancer called non-small cell lung cancer (NSCLC). This is a common form of lung cancer. Specifically, the study is for patients whose cancer is quite advanced but can still be removed with an operation. The main idea is to see if giving a combination of two types of medicine before surgery works better than giving just one type of medicine.

Currently, some patients receive chemotherapy before their surgery to try and shrink the cancer. This study is adding an immune-boosting drug called OPDIVO (which helps your body's immune system fight cancer) to the chemotherapy. Researchers want to find out if this combination can lead to a 'pathological complete response.' This is a medical term for when no active cancer cells are found in the tissue removed during surgery, meaning the treatment has been very effective.

By comparing these two treatment approaches – chemotherapy plus OPDIVO versus chemotherapy alone – doctors hope to learn which method is more successful in treating this specific type of lung cancer before surgery. This could potentially lead to better outcomes for patients in the future.

Key takeaways

The study compares chemotherapy alone vs. chemotherapy plus OPDIVO for lung cancer before surgery.
It's for a specific type of advanced lung cancer that doctors think can be surgically removed.
The main goal is to see if the combined treatment can shrink the cancer more effectively (achieve a 'pathological complete response').
Both men and women aged 18 and over can participate.
Participants will be closely monitored for treatment effects and side effects.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. There is no upper age limit. Both men and women can take part.

You would also need to have been diagnosed with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that is considered 'locally advanced.' This means the cancer has grown within the lungs or nearby lymph nodes but hasn't spread widely to other parts of the body. Importantly, your doctors must also believe that your cancer can be successfully removed by surgery.

There will be other detailed medical checks to make sure this study is safe and appropriate for you. Your blood tests, general health, and other medical conditions would be carefully reviewed by the study doctors.

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 non-small cell lung cancer?
Do your doctors believe your lung cancer can be removed by surgery?
Are you generally well enough to undergo chemotherapy and surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the standard chemotherapy treatment alone or the chemotherapy combined with the OPDIVO drug, both given before your scheduled surgery. These treatments are usually given through a drip into your arm.

Throughout the study, you would have regular hospital visits for appointments. These appointments would involve check-ups, blood tests, scans, and other tests to see how you are responding to the treatment and to monitor your health. After your surgery, doctors would continue to monitor your progress and health for a period of time, even after you've finished the main treatment. The total duration of your involvement could extend for some time, including regular follow-up appointments.

Potential risks and benefits

Participating in a study like this might offer potential benefits, such as receiving a new and potentially more effective treatment, or close medical monitoring. However, there are also potential risks, including side effects from the medications. Both chemotherapy and immunotherapy can cause various side effects, which range from mild to severe. The study team will carefully monitor you for any side effects and provide care. You would also undergo surgery, which carries its own set of risks. It's important to remember that you can decide to withdraw from the study at any time and 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
Spain

Common questions

What is 'non-small cell lung cancer'?

It's the most common type of lung cancer. This study focuses on a stage where it's advanced but can still be removed with surgery.

What is OPDIVO?

OPDIVO is a type of medicine called immunotherapy. It helps your body's immune system recognise and fight cancer cells more effectively.

What does 'pathological complete response' mean?

It's a very good outcome where, after treatment, no active cancer cells are found in the tissue that is removed during surgery.

Will I definitely get the new combined treatment?

No, because it's a 'randomised' study, you will be put into one of two groups by chance: one group gets chemotherapy alone, the other gets chemotherapy plus OPDIVO.

What happens after the main treatment?

After your surgery and initial treatment, you will have regular follow-up appointments and checks to monitor your health and recovery.