Study of Nivolumab and Ipilimumab with Chemotherapy for Patients with Stage IV Non-Small Cell Lung Cancer and Brain Metastases

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC) that has spread to the brain, referred to as brain metastases. The study is exploring a treatment combination that includes two medications, Nivolumab and Ipilimumab, along with two cycles of chemotherapy. Nivolumab, also known by its code name BMS936558, and Ipilimumab, also known as BMS734016, are both given as solutions through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of this study is to determine how effective this combination treatment is in providing benefits to the brain, specifically by assessing if there is no worsening of the disease in the brain for at least six months. Participants in the study will receive the treatment and be monitored over a period of time to see how their cancer responds. The study will also look at other aspects such as the overall response to the treatment, how long the response lasts, and the overall survival of the participants. Additionally, the safety of the treatment and its impact on the quality of life will be evaluated.

Participants will undergo various assessments, including imaging tests like MRI (Magnetic Resonance Imaging), to monitor the progress of the disease and the effects of the treatment. The study aims to provide valuable information on the potential benefits of using Nivolumab and Ipilimumab in combination with chemotherapy for patients with advanced lung cancer that has spread to the brain.

1 enrollment

Upon joining the study, confirmation of eligibility is required. This includes a negative pregnancy test for women of childbearing potential and the use of effective contraception for both men and women during the study and for a specified period after the last dose of trial drugs.

2 initial assessment

An initial assessment is conducted to evaluate the patient’s health status. This includes a review of medical history, physical examination, and imaging tests such as CT and MRI to measure disease in the body and brain.

3 treatment initiation

The treatment begins with the administration of nivolumab and ipilimumab. Both medications are given as a solution for infusion through a vein (intravenous).

The specific dosage and frequency of administration are determined by the study protocol and the patient’s condition.

4 chemotherapy cycles

Two cycles of platinum-based chemotherapy are administered alongside nivolumab and ipilimumab. The exact schedule and dosage are based on the study protocol.

5 ongoing monitoring

Regular monitoring is conducted to assess the patient’s response to treatment. This includes imaging tests and clinical evaluations to check for any progression of the disease.

The primary goal is to determine the rate of intracranial clinical benefit, which means the absence of disease progression in the brain for at least six months.

6 safety and efficacy evaluation

The safety and effectiveness of the treatment are evaluated throughout the study. This includes monitoring for any side effects and assessing the overall response to the treatment.

7 quality of life assessment

The impact of the treatment on the patient’s quality of life is assessed at various points during the study.

8 follow-up

After completing the treatment, follow-up visits are scheduled to continue monitoring the patient’s health and any long-term effects of the treatment.

Who Can Join the Study?

Patients must have non-small cell lung cancer with brain metastasis. This means the lung cancer has spread to the brain.
For Cohort A, patients should have stage IV non-small cell lung cancer that has not been treated with systemic therapy for advanced disease. They should have brain metastases that do not cause symptoms and do not need treatment with corticosteroids (a type of medication) within 10 days before starting the study treatment. Seizures controlled with medication are allowed.
For Cohort B, patients should have stage IV non-small cell lung cancer with brain metastasis causing symptoms that are controlled with low doses of corticosteroids. They should have a good performance status, meaning they can carry out daily activities well.
Patients with early or locally advanced non-small cell lung cancer who have had a recurrence after 6 months of completing chemotherapy and have brain metastases can also participate.
Patients must have an ECOG performance status of 0-1, which indicates they are fully active or have some symptoms but do not need bed rest.
Patients must be 18 years or older.
Patients must have measurable disease in the body and brain, as determined by specific imaging tests like CT (computed tomography) and MRI (magnetic resonance imaging).
A sample of the tumor tissue must be available, either as a block or slides, from a biopsy done within the last 12 months.
Patients must have normal blood, liver, and kidney function.
Patients must agree to participate in the study and provide consent according to local regulations.
Patients must be available for treatment and follow-up visits.
Women who can become pregnant must have a negative pregnancy test before joining the study.
All sexually active men and women who can have children must use a highly effective birth control method during the study and for a period after the study ends (5 months for women and 7 months for men).

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not been diagnosed with brain metastasis, which means the cancer has spread to the brain.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who do not meet other specific health criteria required for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario De Jaen	Jaen	Spain
Consorcio Hospitalario Provincial De Castellon	Castello De La Plana	Spain
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario De Leon	Leon	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Son Llatzer	Palma	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Imhcqxdy Cmeyon Dudngfcnimakspnpu	L'hospitalet De Llobregat	Spain
Hedcmaic Ujvkocofrqsrz Rhurvyvq Dw Mbzdoi	Malaga	Spain
Hwydndzz Du Lo Svnmd Calw I Scrh Pme	Barcelona	Spain
Hvimnxcc Vndo dskdcqvq	Barcelona	Spain
Hwvtwlet Ucfrstmpptcja ds A Coazaa	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	30.05.2024

Trial locations

Investigated drugs:

Nivolumab is a medication that helps the immune system fight cancer. It works by blocking a protein that stops the immune system from attacking cancer cells, allowing the body to better target and destroy them.

Ipilimumab is another medication that boosts the immune system’s ability to fight cancer. It works by activating certain immune cells, which can help the body recognize and attack cancer cells more effectively.

Platinum-based chemotherapy refers to a group of cancer treatments that contain the metal platinum. These medications work by damaging the DNA of cancer cells, which prevents them from dividing and growing. This type of chemotherapy is often used to treat various types of cancer, including lung cancer.

Investigated diseases:

Non-small cell lung cancer

Non-small cell lung cancer with brain metastasis – This disease is a type of lung cancer that begins in the tissues of the lungs and is characterized by the presence of cancerous cells that have spread to the brain. It is the most common type of lung cancer, accounting for a significant majority of cases. The progression involves the cancer cells traveling through the bloodstream or lymphatic system to the brain, forming secondary tumors known as metastases. These brain metastases can lead to neurological symptoms such as headaches, seizures, or changes in behavior, depending on their size and location. The disease can progress as the cancer cells continue to grow and potentially spread to other parts of the body. The presence of brain metastases often indicates an advanced stage of the disease.

Trial ID:

2024-513866-20-00

Protocol code:

GECP 21/02

NCT ID:

NCT05012254

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Nivolumab and Ipilimumab with Chemotherapy for Patients with Stage IV Non-Small Cell Lung Cancer and Brain Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?