Study Comparing Nivolumab with Ipilimumab or Nivolumab with Chemotherapy to Chemotherapy Alone 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 Early Stage Non-Small Cell Lung Cancer (NSCLC). The study is exploring the effectiveness of different treatment combinations, including Nivolumab and Ipilimumab, as well as Nivolumab combined with a type of chemotherapy known as Platinum-Doublet Chemotherapy. The trial also includes a comparison with the use of Platinum-Doublet Chemotherapy alone. The purpose of the study is to evaluate how these treatments affect the progression of the disease and the response of the cancer to treatment.

Participants in the study will receive one of the treatment combinations or a placebo. The treatments are administered through an intravenous infusion, which means they are given directly into the bloodstream. The study will monitor participants over a period of time to assess the impact of the treatments on the cancer, including how long participants remain free of cancer events and the rate of complete response, where no cancer is detected in tissue samples after treatment.

The trial aims to provide valuable information on the effectiveness of these treatment combinations in managing Early Stage Non-Small Cell Lung Cancer. By comparing different treatment approaches, the study seeks to identify the most effective strategy for improving outcomes for patients with this type of lung cancer. The study is expected to continue until 2028, with ongoing assessments of participants’ health and response to the treatments.

1 joining the trial

Upon joining the clinical trial, you will be informed about the study’s purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the details.

2 initial assessment

You will undergo an initial assessment to confirm your eligibility. This includes a review of your medical history, a physical examination, and tests to evaluate your lung function and overall health.

3 treatment assignment

You will be randomly assigned to one of the treatment groups. The groups include: nivolumab plus ipilimumab, nivolumab plus platinum-doublet chemotherapy, or platinum-doublet chemotherapy alone.

4 treatment administration

The treatment will be administered through an intravenous infusion, which means the medication is given directly into your vein. The specific medications and their combinations will depend on your assigned group.

The treatment schedule will be explained to you, including the frequency and duration of each medication. For example, nivolumab is typically given every two weeks, while chemotherapy may follow a different schedule.

5 regular monitoring

Throughout the trial, you will have regular visits to monitor your health and response to the treatment. This includes physical exams, blood tests, and imaging studies like CT scans to assess the cancer’s status.

6 completion of treatment

Once the treatment phase is completed, you will undergo a final assessment to evaluate the treatment’s effectiveness and any side effects experienced.

7 follow-up

After completing the treatment, you will continue to have follow-up visits to monitor your long-term health and any lasting effects of the treatment. These visits are crucial for understanding the treatment’s impact over time.

Who Can Join the Study?

Must have early stage non-small cell lung cancer (NSCLC) that can be operated on. This should be confirmed through a tissue sample.
Must have lung function that is strong enough to handle the planned lung surgery.
Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1, which means you are fully active or have some symptoms but can still carry out light work.
Must have available tissue from the primary lung tumor for testing.
Both male and female participants are eligible.
Participants from vulnerable populations are eligible.

Who Cannot Join the Study?

Patients with a history of another type of cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer (a very early stage of cervical cancer).
Patients who have received any other cancer treatment within the last 4 weeks.
Patients with an active infection that requires treatment with antibiotics.
Patients with a known allergy to the study drugs or their ingredients.
Patients with a serious heart condition, such as heart failure or a recent heart attack.
Patients with uncontrolled high blood pressure.
Patients with a history of autoimmune disease, which is when the immune system attacks the body’s own cells.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial.
Patients with a history of drug or alcohol abuse within the last 2 years.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita’ Degli Studi Di Perugia	Perugia	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Hôpital Pontchaillou-CHU Rennes	Rennes	France
Cypihh Hraoljicfme Ruuztftj Ussitsxvwcput Do Tkyef	Tours	France
Hpobaofe Vfux dyfkoxnr	Barcelona	Spain
Ieswksec Cogsl	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	13.01.2017
Italy	Not recruiting	13.01.2017
Romania	Not recruiting	13.01.2017
Spain	Not recruiting	13.01.2017

Trial locations

Investigated drugs:

Nivolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is being used to see if it can improve outcomes for patients with early-stage non-small cell lung cancer (NSCLC) when combined with other treatments.

Ipilimumab is another immune checkpoint inhibitor. It helps activate your immune system to fight cancer cells. In this study, it is being tested in combination with nivolumab to determine if the two medications together can provide better results for patients with early-stage NSCLC.

Platinum-Doublet Chemotherapy is a standard treatment for lung cancer that uses two chemotherapy drugs, one of which contains platinum. This combination works by killing cancer cells or stopping them from growing. In this trial, it is being used both alone and in combination with nivolumab to see which approach is more effective for treating early-stage NSCLC.

Investigated diseases:

Non-small cell lung cancer

Early Stage Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the tissues of the lung and is characterized by the size and spread of the tumor. In its early stages, the cancer is typically confined to the lung and may involve nearby lymph nodes. The disease progresses as the cancer cells grow and multiply, potentially spreading to other parts of the body. Early stage NSCLC is often categorized into stages IB, II, and resectable IIIA, based on the size of the tumor and the extent of lymph node involvement. As the disease advances, it may become more challenging to manage due to increased tumor size and potential spread to distant organs. The progression of NSCLC can vary significantly among individuals, depending on various factors such as genetic mutations and overall health.

Trial ID:

2022-501360-18-00

Protocol code:

CA209-816

NCT ID:

NCT02998528

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Nivolumab with Ipilimumab or Nivolumab with Chemotherapy to Chemotherapy Alone 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?