Study of IPH5201 and Durvalumab for Pre- and Post-Surgery Treatment in Patients with Early-Stage Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for , a type of lung cancer that is common and can be serious. The study involves two main treatments: and (also known as ). These treatments are given to patients before and after surgery to see how well they work in reducing the cancer. The purpose of the study is to assess the effectiveness and safety of these treatments in patients with early-stage lung cancer that can be surgically removed.

Participants in the study will receive the treatments through an intravenous infusion, which means the medicine is given directly into a vein. The study will take place over a period of up to 12 months. During this time, doctors will monitor the patients to see how the cancer responds to the treatment and to check for any side effects. Some patients may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study aims to find out if the treatments can help achieve a complete response, meaning no cancer cells are found after surgery. It will also look at how long patients remain free of cancer after treatment and surgery. The results will help determine if these treatments can be a safe and effective option for people with early-stage .

1 neoadjuvant treatment

The initial phase involves the administration of medications before surgery. This is known as neoadjuvant treatment.

You will receive two medications: IPH5201 and durvalumab. Both are given through a vein, a method called intravenous administration.

The goal of this phase is to reduce the size of the tumor and assess the response to the treatment.

2 surgery

After completing the neoadjuvant treatment, surgery will be performed to remove the lung cancer.

The type of surgery will depend on the specific characteristics of your condition and may include procedures like lobectomy or sleeve resection.

The surgery aims to remove all visible cancer.

3 adjuvant treatment

Following surgery, adjuvant treatment is administered to eliminate any remaining cancer cells and reduce the risk of cancer returning.

This phase involves the continued use of durvalumab, administered intravenously.

The duration and frequency of this treatment will be determined based on your individual response and overall health.

4 follow-up

Regular follow-up appointments will be scheduled to monitor your recovery and check for any signs of cancer recurrence.

These appointments may include physical exams, imaging tests, and laboratory tests.

The follow-up phase is crucial for ensuring long-term health and managing any potential side effects of the treatment.

Who Can Join the Study?

Must be able to give signed permission to participate, agreeing to follow the study’s rules and requirements.
Must be at least 18 years old.
Must have been newly diagnosed with Non-Small Cell Lung Cancer (NSCLC) and not have received any treatment for it before.
The cancer must be in a stage that can be surgically removed, specifically Stage IIA to Stage IIIA.
Must be a candidate for specific types of lung surgery: lobectomy, sleeve resection, or bilobectomy.
Must have a WHO Performance Status or ECOG Performance Status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have adequate organ and bone marrow function, which includes having enough red blood cells, white blood cells, and platelets, and normal liver and kidney function.
Must have a life expectancy of at least 12 weeks.
Must weigh more than 35 kg (about 77 pounds).
Both men and women can participate.
Women who can have children must have a negative pregnancy test.
Must provide a sample of the tumor for testing specific markers like PD-L1, EGFR, or ALK.
Must provide a tumor sample for additional research purposes.
Must be eligible for surgery, with specific lung function tests showing a certain level of lung capacity.

Who Cannot Join the Study?

Patients with other types of cancer besides Non-Small Cell Lung Cancer stages II, III, or IIIA cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to safely undergo surgery cannot participate.
Patients with serious health conditions that could interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have received certain treatments recently that could affect the study cannot participate.
Patients who are unable to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Koranyi National Institute For Pulmonology	Budapest	Hungary
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Farkasgyepui Tudogyogyintezet	Farkasgyepu	Hungary
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet	Szolnok	Hungary
Henry Dunant Hospital Center	Athens	Greece
University General Hospital Of Ioannina	Ioannina	Greece
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy	Warsaw	Poland
General University Hospital Of Patras	Patras	Greece
Centre Hospitalier Universitaire De Rennes	Rennes	France
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Szpital Specjalistyczny W Prabutach Sp. z o.o.	Prabuty	Poland
Cqkhqk Lgez Bkwsve	Lyon	France
Cwbovt Hdngbrraksp Ee Urixcsvcdzjbr Ds Lbgbqld	Limoges	France
Akovgfinvu Pcsomsfp Hkfmsjjf Db Mknqswmeo	Marseille	France
Gludmkqzhrerxrebm Vgqvynugz Pmku Aigfut Ephhstxk Ozibbl Kycpwe	Gyor	Hungary
Cwafqt Hkforrossbt Rdpmclkz Dvptxpbvseuqgj	Angers	France
Umtejgagpb Glfjwkl Haclytay Aqiwzpy	Athens	Greece

Trial status

Country	Status	Recruitment Start
France	Recruiting	06.06.2023
Greece	Recruiting	06.06.2023
Hungary	Recruiting	06.06.2023
Poland	Recruiting	06.06.2023

Trial locations

Investigated drugs:

IPH5201 is an investigational medication being studied for its potential to help the immune system fight cancer. It is used in this trial as a treatment before and after surgery to see if it can improve outcomes for patients with early-stage non-small cell lung cancer.

Durvalumab is a medication that helps the immune system attack cancer cells. It is used in this trial to see if it can enhance the body’s immune response against lung cancer when given before and after surgery.

Investigated diseases:

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath may occur. The progression of the disease is categorized into stages, with stages II, III, and IIIA indicating more advanced disease where the cancer has spread to nearby lymph nodes or other areas within the chest. The progression and impact on the body can vary based on the specific subtype and stage of the cancer.

Trial ID:

2023-507778-42-00

Protocol code:

IPH5201-201

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of IPH5201 and Durvalumab for Pre- and Post-Surgery Treatment in Patients with Early-Stage Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?