Study of subcutaneous nivolumab with ipilimumab and chemotherapy in previously untreated patients with metastatic or recurrent non-small cell lung cancer

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What is this study about?

This study focuses on treating Non-small cell lung cancer (NSCLC) that has spread to other parts of the body or has come back after previous treatment. The study will test a combination of different medications: nivolumab (given as an injection under the skin), ipilimumab (given through a vein), and chemotherapy drugs including pemetrexed, cisplatin, carboplatin, and paclitaxel.

The main purpose of this research is to understand how the body processes nivolumab when it is given under the skin in two different doses, along with ipilimumab and chemotherapy. The study will look at how the medications work together and how they are processed by the body.

During the study, participants will receive nivolumab as an injection under the skin, while ipilimumab and chemotherapy medications will be given through a vein. The treatment will continue for up to 24 months. Throughout the study, doctors will monitor how participants respond to the treatment and check for any side effects that may occur.

1 Initial treatment cycle

You will receive a combination of medications through different methods:

– Nivolumab given as an injection under the skin

– Ipilimumab given through an intravenous (IV) line

– Chemotherapy medications (pemetrexed, cisplatin/carboplatin, paclitaxel) given through an IV line

During this first cycle, blood samples will be taken to measure how the medications are processed by your body

2 Continued treatment cycles

Treatment will continue in cycles

Blood tests will be performed before each new treatment cycle

Your response to treatment will be monitored through CT or MRI scans

3 Seventh treatment cycle

Additional blood samples will be taken before receiving the next dose

These samples will measure the amount of nivolumab remaining in your body

4 Monitoring period

Your health will be monitored for any side effects throughout the treatment

The monitoring will continue for 100 days after the end of treatment

Doctors will check for:

– General side effects

– Serious health issues related to treatment

– Immune system reactions

– Development of antibodies to the medications

5 Study completion

The study is expected to continue until October 2028

Your participation will end after completing the 100-day monitoring period following your last treatment

Who Can Join the Study?

Must be at least 18 years old at the time of signing the consent form
Must have confirmed stage IV or recurrent non-small cell lung cancer (cancer that has spread to other parts of the body or has come back)
Must not have received any previous systemic treatment (medication that travels through the bloodstream) for advanced or spreading cancer
If you had previous treatment combining chemotherapy and radiation for locally advanced cancer, it must have been completed at least 6 months before joining the study
If you had chemotherapy for early-stage lung cancer, it must have been completed at least 6 months before joining the study
Must have good physical function ability (able to carry out light daily activities) with an ECOG Performance Status of 0 or 1
Must have tumors that can be measured by CT scan or MRI according to specific measurement criteria (RECIST 1.1), with imaging done within 28 days before starting the study
Both men and women can participate in the study

Who Cannot Join the Study?

People below 18 years of age
Pregnant or breastfeeding women
People with known active or untreated brain metastases (cancer that has spread to the brain)
Patients with active autoimmune disease (when body’s immune system attacks healthy cells)
People who have received other cancer treatments within 4 weeks before starting this study
Patients with serious heart conditions or uncontrolled high blood pressure
People with active infections requiring treatment
Patients who have had organ transplants
People currently participating in other clinical trials
Individuals with known allergies to the study medications
Patients with severe liver or kidney problems
People with conditions that might interfere with study procedures or evaluation
Patients taking medications that could interact with the study drugs
People unable to follow study instructions or attend scheduled visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Centr Georges Francois Leclerc	Dijon	France

Other Sites

Site Name	City	Country
Hospital Foch	Suresnes	France
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Instytut Centrum Zdrowia Matki Polki	Lodz	Poland
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Centrul De Diagnostic Si Tratament Provita S.A.	Bucharest	Romania
Mazowiecki Szpital Onkologiczny Sp. z o.o.	Wieliszew	Poland
General University Hospital Of Larissa	Larissa	Greece
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Institutul Regional De Oncologie Iasi	Iasi	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
Szpital Specjalistyczny W Prabutach Sp. z o.o.	Prabuty	Poland
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara	Chaidari	Greece
Tburbeeymz Cgmpal Hynuexis	Thessaloniki	Greece
Ldcya Ggunalo Hxainlqv Ox Avievw	Athens	Greece
Inkwpvbo Rjgoqcwnw Pph Ls Sxshtj Dtk Tgzqtg Dbzs Agoarqi Iaij Swdojr	Meldola	Italy
Aycveio Oyhffncakif Pxep Gzoqejjo Xssri	Bergamo	Italy
Gwegmb Hieramwoqsi Uudxznqwynfgp Puqdg Pzbeamuztem Ef Nfvodmxkgfmm	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	16.06.2025
Greece	Recruiting	16.06.2025
Italy	Recruiting	16.06.2025
Poland	Not recruiting	16.06.2025
Romania	Not recruiting	16.06.2025

Trial locations

Investigated drugs:

Nivolumab is a medication used to treat certain types of cancer. It works by helping your immune system fight cancer cells. In this trial, it is given as an injection under the skin (subcutaneously).

Ipilimumab is another cancer treatment that helps activate your immune system to fight cancer cells. In this trial, it is administered through an intravenous (IV) infusion, which means it goes directly into your bloodstream through a vein.

This trial also includes chemotherapy treatment, which uses medications to kill cancer cells or stop them from growing. The specific chemotherapy drugs used in this trial are not specified in the source data.

These medications are being tested in combination to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body (metastatic) or has come back (recurrent), and hasn’t been treated before.

Investigated diseases:

Non-small cell lung cancer (NSCLC) – A type of lung cancer that develops in the cells lining the airways of the lungs. It begins when healthy cells in the lung change and grow out of control, forming a mass called a tumor. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease usually starts in the flat cells that line the airways (squamous cells) or in the cells that produce mucus (adenocarcinoma). As the cancer grows, it can spread to nearby lymph nodes and other parts of the body.

Trial ID:

2024-520108-25-00

Protocol code:

CA209-1533

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of subcutaneous nivolumab with ipilimumab and chemotherapy in previously untreated patients with metastatic or recurrent non-small cell lung cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?