AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Adoptive TIL therapy in combination with chemoimmunotherapy in advanced NSCLC patients

Researchers are conducting a very early study (Phase 1) to investigate a new treatment approach for advanced non-small cell lung cancer. This treatment involves using 'adoptive TIL therapy,' which is a type of immunotherapy where your own immune cells are grown in a lab and then given back to you to help fight cancer. This is being given alongside standard chemotherapy and another type of immunotherapy. The main aim of this first study in humans is to check if the treatment is safe and to understand how the body reacts to it. It's for adults (18 and over) diagnosed with advanced non-small cell lung cancer, and people of all genders can take part.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Enrolment target

Start

15 Nov 2024

Respiratory tract diseases

What is this study about?

This study is about exploring a new way to treat a type of lung cancer called non-small cell lung cancer, specifically when it's advanced. Lung cancer is a common and serious illness, and finding new treatments is really important.

The treatment being tested is a combination. One part is called 'adoptive TIL therapy'. TIL stands for Tumour Infiltrating Lymphocytes. These are powerful immune cells that your body naturally sends to fight cancer. In this therapy, doctors take some of these cells from your tumour, grow many more of them in a lab, and then give them back to you.

This TIL therapy is being given together with two other common cancer treatments: chemotherapy (medicines that kill fast-growing cells, including cancer cells) and immunotherapy (another type of treatment that helps your immune system fight cancer). This is a very early study (Phase 1), which means it's one of the first times this specific combination is being tried in people. The main goal is to see if it's safe and to understand what effects it has on the body.

Key takeaways

This is an early-stage (Phase 1) study for advanced non-small cell lung cancer.
It tests a new combination of treatments: adoptive TIL therapy, chemotherapy, and immunotherapy.
The main goal is to check for safety and how the treatment affects the body.
It's open to adults (18+) of all genders.
Participation involves regular hospital visits and monitoring.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults who have been diagnosed with advanced non-small cell lung cancer. Generally, this means your cancer has spread or is difficult to treat with standard methods.

To be considered for the study, you must be 18 years old or older. There is no upper age limit mentioned, meaning older adults may also be able to participate. Both men and women are welcome to take part in this research.

Beyond these basic requirements, there will be other specific medical checks and tests to make sure that taking part in the study is safe for you. This will include looking at your overall health, any other medical conditions you might have, and your previous treatments.

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.
I am willing to attend regular hospital appointments.
My doctor has confirmed my cancer type fits the study criteria.
I am open to receiving new and experimental treatments.

Answer every question to see your result.

What does participation involve?

Taking part in a clinical study like this involves several steps. You would have initial appointments where doctors check your health, blood, and cancer status to see if the study is right for you. If you qualify and choose to join, you will receive the study treatments, which include the adoptive TIL therapy, chemotherapy, and immunotherapy. These treatments will be given at the hospital.

You will need to attend regular hospital visits for check-ups, blood tests, and scans to monitor your health and how the treatment is working. There will also be follow-up appointments after your treatment period to see how you are doing in the longer term. The total duration of participation and the exact number of visits will be explained in detail by the study team.

Potential risks and benefits

As with any medical treatment, there are potential benefits and risks. The potential benefit of this study is that this new combination treatment might help control your advanced lung cancer better than current treatments. However, because this is an early-stage study, we don't know for certain if it will work. Potential risks could include side effects from the chemotherapy, immunotherapy, or the adoptive TIL therapy, such as tiredness, nausea, infections, or immune reactions. The study team will explain all known potential side effects and monitor you closely. Remember, 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
Netherlands

Common questions

What is 'adoptive TIL therapy'?

It's a treatment where special immune cells (TILs) from your tumour are grown in a lab to create many more, then given back to you to help fight your cancer.

What does 'Phase I' mean for a study?

Phase I means it's one of the first times this treatment is given to people. The main goals are to check if it's safe and to find the right dose.

Will I still get my usual cancer care if I join this study?

Yes, joining the study will combine the new treatment with some standard cancer care, but your overall medical care will continue to be managed by your doctors.

Will I have to pay to be part of the study?

No, you do not have to pay to participate in the study treatments or assessments directly related to the research.

Can I leave the study if I change my mind?

Yes, you can decide to leave the study at any time, and it will not affect your future medical care.