RecruitingPHASE2INTERVENTIONAL

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

This study is testing a new treatment called LN-145 for people with advanced non-small cell lung cancer that has spread to other parts of the body (metastatic). This treatment uses your body's own immune cells, called TILs, which are specially prepared to fight your cancer. Doctors will take a small piece of your tumour to grow these cells in the lab. Once ready, you'll receive some medicine to prepare your body, then the prepared immune cells will be given back to you through a drip, followed by another medicine to help them grow. The main aim is to see how well LN-145 works and if it's safe for patients with this type of lung cancer who have already had previous treatments.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Iovance Biotherapeutics, Inc.

Enrolment target

170

Start

07 May 2021

Estimated completion

01 Dec 2031

Metastatic Non Small Cell Lung Cancer

What is this study about?

This study is exploring a new way to treat non-small cell lung cancer that has spread. This type of cancer can be challenging to treat, especially when standard therapies are no longer working well. The treatment being tested is called LN-145, and it's a type of immunotherapy. Immunotherapy works by boosting your body's own immune system to recognise and fight cancer cells.

Specifically, LN-145 uses special immune cells called Tumour Infiltrating Lymphocytes (TILs). These are immune cells that have already found their way into a tumour, suggesting they might be trying to fight the cancer. In this study, doctors will take a small piece of your tumour during a procedure. From this tissue, they will find and grow these TILs in the lab to make many more of them. These specific cells are then given back to you through a drip.

The idea behind this treatment is to give your body a powerful army of its own immune cells, trained to specifically target and destroy your cancer cells. By making a large amount of these cancer-fighting cells and giving them back to you, researchers hope to see if this can control the cancer. This study is an important step in finding new and more effective treatments for metastatic non-small cell lung cancer.

Key takeaways

Tests a new immunotherapy (LN-145) for advanced lung cancer (non-small cell type).
Uses your own immune cells (TILs) to fight the cancer.
For patients who have already tried other treatments.
Aims to see how safe and effective the treatment is.
Involves a tumour biopsy, cell growing in a lab, and then infusion back into you.

Who may be eligible?

This study is for adults, generally aged 18 to 70, who have been diagnosed with non-small cell lung cancer that has spread (metastatic Stage IV). Importantly, your cancer should not have specific changes in genes called EGFR, ALK, or ROS1. If you have other genetic changes that can be treated, you'll need to have tried the usual targeted therapies for those first.

To join, your cancer must have grown or spread after you've already had at least one common type of treatment, often involving a combination of immunotherapy and chemotherapy. You might also be eligible if you have cancer that can be removed but are planning to have this specific cell therapy after your cancer has progressed. You will need to have a tumour that can be safely removed to collect the immune cells, and at least one other tumour that doctors can measure to see if the treatment is working. You also need to be generally well, with good heart and lung function, and be able to do your daily activities with little difficulty.

For safety, both men and women who could potentially have children must agree to use effective birth control during and for 12 months after the treatment period.

Quick self-check

Is my non-small cell lung cancer metastatic (has it spread)?
Have I already tried other treatments for my lung cancer?
Do I have a tumour that can be removed for cell collection?
Am I generally well and able to carry out daily activities?
Are my heart and lung functions good?
Am I between 18 and 70 years old?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, the first step is to have a small piece of your tumour removed. This tissue will be sent to a special lab to grow your immune cells (TILs). While your cells are being prepared, you will have regular check-ups and continue to receive care. Once your cells are ready, you will have a short course of medicine, given through a drip, to prepare your body. This is followed by a single infusion (drip) of your prepared LN-145 cells. Afterwards, you will receive another medicine (IL-2) for a few days to help boost these cells. You will have regular hospital visits, blood tests, and scans to monitor your health and how the treatment is working. The total time you will be involved in the study will depend on how you respond to the treatment and the follow-up required by the researchers.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment that could help control your lung cancer, especially if other treatments haven't worked well. However, like all medical treatments, there are potential risks and side effects from the preparing medicines, the cell infusion, and the follow-up medication. These can vary from mild to more serious and will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (91)

Banner Health MD Anderson
Gilbert, United States· Recruiting
City of Hope
Duarte, United States· Withdrawn
UC San Diego Moores Cancer Center
La Jolla, United States· Withdrawn
University of Southern California
Los Angeles, United States· Withdrawn
Christiana Care Health System
Newark, United States· Withdrawn
University of Florida Health Cancer Center
Gainesville, United States· Withdrawn
Sylvester Comprehensive Cancer Center
Miami, United States· Recruiting
AdventHealth Cancer Institute
Orlando, United States· Withdrawn
H Lee Moffitt Cancer Center and Research Institute
Tampa, United States· Recruiting
Augusta University
Augusta, United States· Recruiting
Rush University Medical Center
Chicago, United States· Withdrawn
University of Illinois Hospital & Health Sciences System
Chicago, United States· Withdrawn

+79 more sites — see the official record for the full list.

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer, and it's called 'non-small cell' because of how the cancer cells look under a microscope.

What does 'metastatic' mean?

Metastatic means the cancer has spread from where it started in the lung to other parts of the body.

What are 'TILs'?

TILs (Tumour Infiltrating Lymphocytes) are immune cells found inside a tumour that your body uses to try and fight the cancer.

Will I have to stay in hospital?

You will likely need to stay in hospital for the cell infusion and the medicine given afterward, and then for follow-up monitoring.

Is this a new type of treatment?

Yes, this is an experimental therapy using your own immune cells to target the cancer, currently being tested in clinical trials.

How to find out more

Iovance Biotherapeutics Study Team lungcelltherapy.com

Clinical.Inquiries@iovance.com 1-844-845-4682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.