Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

IFCT-1701 DICIPLE A randomized phase 3 trial comparing continuation Nivolumab-Ipilimumab doublet immunotherapy until progression versus observation in treatment-naive patients with stage IV Non-Small Cell Lung Cancer (NSCLC) after Nivolumab-Ipilimumab induction treatment

This UK clinical trial is for people with advanced lung cancer (non-small cell lung cancer, stage IV) who haven't had treatment before. The study is trying to understand the best way to manage this type of cancer after an initial course of treatment with two immunotherapy drugs, Nivolumab (Opdivo) and Ipilimumab (Yervoy). Participants will be randomly assigned to one of two groups: one group will continue receiving the Nivolumab-Ipilimumab combination until the cancer grows or symptoms worsen, and the other group will be carefully watched without further active treatment after the initial phase. The main aim is to see which approach keeps the cancer from growing for longer. Researchers will also look at quality of life and overall survival. The study involves adults aged 18 and over, of any sex.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Intergroupe Francophone De Cancerologie Thoracique

Enrolment target

1,360

Start

21 Jan 2025

Non small cell lung cancer

What is this study about?

This research study is about advanced non-small cell lung cancer, which is a common type of lung cancer that has spread to other parts of the body. Doctors are always looking for better ways to treat this condition.

In this study, participants with advanced lung cancer will first receive a combination of two special drugs called Nivolumab (also known as Opdivo) and Ipilimumab (also known as Yervoy). These drugs are a type of immunotherapy. Immunotherapy works by helping your body's own immune system fight the cancer. After this initial treatment, the study wants to find out what the best next step is.

Some people in the study will continue to receive the Nivolumab and Ipilimumab combination until their cancer starts to grow again or they experience difficult side effects. Others will have a break from active treatment and be closely monitored by their doctors. By comparing these two approaches, the researchers hope to learn whether continuing the immunotherapy drugs for longer helps keep the cancer under control for a longer time, improves quality of life, or helps people live longer overall. They will also look at how the body's immune system responds to the treatment.

Key takeaways

This study compares two approaches after initial immunotherapy for advanced lung cancer.
It aims to find out if continuing immunotherapy keeps cancer from growing longer.
Participants will be randomly assigned to either ongoing treatment or observation.
The study measures how long the cancer stays stable, quality of life, and overall survival.
It involves adults with untreated, advanced non-small cell lung cancer.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. Both men and women can take part. Crucially, you must have advanced non-small cell lung cancer (stage IV) and not have received any previous treatment for your cancer, meaning this would be your first official treatment plan.

The study also has other specific medical requirements that your doctor would need to review to make sure it's safe and appropriate for you. For example, your general health, other medical conditions you might have, and results from specific blood tests or scans would all be checked to see if you fit all the study's criteria.

It's important to remember that these are just general guidelines. Your cancer specialist would be able to go through all the detailed requirements with you and determine if this trial is a suitable option for your particular situation.

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.

I am 18 years old or older.
I have been diagnosed with advanced non-small cell lung cancer (stage IV).
I have not had any previous treatment for my lung cancer.
I am willing to receive the initial immunotherapy combination.
I understand that I might either continue treatment or be observed after the initial phase.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first receive a specific initial course of treatment with the two immunotherapy drugs, Nivolumab and Ipilimumab, given as infusions into your vein. After this initial treatment phase, you would be randomly assigned to one of two groups, like flipping a coin. You wouldn't be able to choose which group you are in.

One group would continue to receive regular infusions of both Nivolumab and Ipilimumab until your doctors observe your cancer growing or until you experience side effects that make continuing treatment difficult. The other group would stop the active immunotherapy treatment after the initial phase and would be regularly monitored with scans and clinic visits to see how your cancer is doing.

Both groups would have regular doctor's visits, scans (like CT scans), and blood tests to monitor your health, how the cancer is responding, and to check for any side effects. The total duration of your participation would depend on how your cancer responds to treatment, but you would be regularly followed up by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as gaining access to new treatments before they are widely available and contributing to medical knowledge that could help others in the future. However, there are also potential risks of side effects from the study drugs, some of which can be serious, or that the treatment may not work for you. Being in a clinical trial involves more hospital visits and tests than standard care. You have the right to withdraw from the study at any time, for any reason, without 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 immunotherapy?

Immunotherapy is a type of cancer treatment that helps your body’s own immune system fight cancer cells. It’s different from chemotherapy, which directly attacks cancer cells.

What are Nivolumab (Opdivo) and Ipilimumab (Yervoy)?

These are two specific immunotherapy drugs. They work in different ways to boost your immune system's ability to find and destroy cancer cells. In this study, they are used together.

What does 'randomized' mean?

Randomized means that people are put into different treatment groups by chance, like drawing names from a hat. This helps make sure the study results are fair and unbiased.

What is 'Progression-Free Survival'?

This is a key measure in cancer studies. It means the length of time a person lives with the disease without it getting worse or spreading. Researchers want to see if one treatment keeps the cancer from growing for longer.

Will I know if I'm getting the drug or being watched?

Yes, once you've completed the initial combined treatment, you will know whether you are in the group continuing the drugs or the group being observed.