RecruitingPHASE2INTERVENTIONAL

IPH5201 and Durvalumab in Patients With Resectable Non-Small Cell Lung Cancer (MATISSE)

This study, called MATISSE, is exploring a new treatment approach for people with early-stage non-small cell lung cancer that can be removed with surgery. It combines two investigational drugs, IPH5201 and durvalumab, with the usual chemotherapy. The treatment plan involves taking these medicines before surgery, and then continuing with IPH5201 and durvalumab after surgery. The main goals are to find out if this combination is safe and if it works better than current treatments in shrinking the cancer and preventing it from coming back. This is a Phase 2 study, meaning it's still in the earlier stages of research, but it's an important step in finding new ways to fight lung cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Innate Pharma

Enrolment target

Start

23 Jun 2023

Estimated completion

01 Sep 2026

Non Small Cell Lung Cancer

What is this study about?

This study is for people who have early-stage non-small cell lung cancer that their doctors believe can be fully removed with surgery. The study is investigating a new treatment plan that combines standard chemotherapy with two new drugs called IPH5201 and durvalumab. These new drugs are designed to work with your body's immune system to fight cancer.

The researchers want to see if giving this combination of medicines *before* surgery can help to shrink the tumour more, making the surgery potentially more effective. After the surgery, patients will continue to receive IPH5201 and durvalumab to try and reduce the risk of the cancer coming back. The study is focused on understanding how safe this new combination is and how well it works compared to current treatments.

This is a 'Phase 2' study, which means it's still in the early stages of testing. Researchers are collecting important information to decide if this treatment shows enough promise to be studied in even larger groups of people. Getting involved in such a study can help scientists learn more about lung cancer and potentially develop better treatments for the future.

Key takeaways

Targets early-stage Non-Small Cell Lung Cancer that can be surgically removed.
Investigates new drugs (IPH5201, durvalumab) combined with standard chemotherapy.
Treatment is given both before and after surgery.
Aims to check safety and how well the treatment works.
This is a Phase 2 study, part of early-stage research.
Participation could help advance lung cancer treatment.

Who may be eligible?

To join this study, you must have been recently diagnosed with non-small cell lung cancer that is in an early stage (Stage II to IIIA) and can be removed with an operation. You must not have had any treatment for this cancer yet. Your general health should be good enough for surgery and treatment, and you need to be able to carry out your usual daily activities without too much difficulty.

There are also some specific medical requirements. For example, your body weight must be over 35 kg (about 5 and a half stone). Your internal organs, such as your liver, kidneys, and bone marrow, need to be working well. Women who could become pregnant must use reliable birth control throughout the study. Also, doctors will need to check samples of your tumour to understand its specific characteristics.

You would not be able to join the study if you have certain types of lung cancer changes (called EGFR mutations or ALK translocations), or if you have a history of certain serious conditions like organ transplants, some autoimmune diseases, or uncontrolled heart or lung problems. Also, you cannot have had certain blood clot events in the last six months. The doctors will carefully review your medical history to make sure the study is right for you.

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.

Have I been diagnosed with early-stage non-small cell lung cancer that can be operated on?
Have I received any treatment for my lung cancer already?
Am I generally well enough to have surgery and treatment?
Are my kidneys, liver, and other major organs working normally?
If I am a woman of childbearing potential, am I willing to use contraception during the study?
Do I weigh more than 35 kg (about 5 and a half stone)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive a combination of IPH5201, durvalumab, and standard chemotherapy before your planned surgery. After your surgery, you will continue to receive just IPH5201 and durvalumab. You will have regular appointments for check-ups, blood tests, scans, and other assessments to monitor your health and how the treatment is working. These visits will be needed to measure the effects of the medicines and make sure you are tolerating them well. The total length of your participation, including the treatment period and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to new and innovative treatments that are not yet widely available. This new treatment might help shrink your cancer more effectively before surgery or reduce the chance of it returning. However, like all medicines, the study drugs may have side effects, which could be mild or more serious. The study team will monitor you closely for any side effects and will explain the known risks in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (30)

St. Anthony's Hospital - BayCare Health System
Verified postcode
St. Petersburg, United States· Recruiting
H. Lee Moffitt Cancer Center & Research Institute
Verified postcode
Tampa, United States· Recruiting
University of Chicago Medical Center
Verified postcode
Chicago, United States· Not yet recruiting
Northwell Health Cancer Institute / Center for Novel Cancer Therapeutics
Verified postcode
Lake Success, United States· Not yet recruiting
Millennium Research & Clinical Development
Verified postcode
Houston, United States· Recruiting
UW Carbone Cancer Center - Cancer Connect
Verified postcode
Madison, United States· Recruiting
Angers University Hospital Center
Verified postcode
Angers, France· Recruiting
University Hospital Center Caen
Verified postcode
Caen, France· Recruiting
Hospital Calmette
Verified postcode
Lille, France· Not yet recruiting
CHU de Limoges
Verified postcode
Limoges, France· Recruiting
Leon Berard Center
Verified postcode
Lyon, France· Recruiting
Marseille University Hospital Center - North Hospital
Verified postcode
Marseille, France· Recruiting

Common questions

What type of lung cancer is this study for?

This study is for early-stage Non-Small Cell Lung Cancer (NSCLC) that can be removed with surgery.

What medicines are involved in this study?

The study uses a combination of two investigational drugs, IPH5201 and durvalumab, plus standard chemotherapy.

Will I have treatment before and after surgery?

Yes, you will receive the drug combination and chemotherapy before surgery, and then IPH5201 and durvalumab after surgery.

Is this a new treatment?

Yes, IPH5201 and durvalumab are investigational drugs, meaning they are still being studied to see how safe and effective they are.

Who can join this study?

Adults aged 18 or older with early-stage NSCLC that can be surgically removed, who have not yet received cancer treatment, and meet specific health criteria.

How to find out more

Innate Pharma

clinical.trials@innate-pharma.fr +33484903084 Official trial record

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