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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

13 criteria

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 trial?

5 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Complejo Hospitalario Universitario Insular Materno Infantil
Verified
Las Palmas De Gran Canaria, Spain
Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain
Hospital Universitario De Jaen
Responsive
Jaen, Spain

Trial locations

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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.

What is already known about the treatment

Nivolumab
Nivolumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer with brain metastasis. It is an approved medication in the field of oncology and is well-documented in medical literature. The main therapeutic indication for Nivolumab is as a treatment for various types of cancer, including lung cancer. At the molecular level, it works by blocking the PD-1 protein on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.
Ipilimumab
Ipilimumab is given through intravenous infusion and is being evaluated in combination with other drugs for treating non-small cell lung cancer with brain metastasis. It is an established medication in cancer treatment and is widely referenced in medical literature. The primary therapeutic use of Ipilimumab is in the treatment of melanoma and other cancers. Its mechanism of action involves blocking the CTLA-4 protein on T-cells, which boosts the immune system's ability to fight cancer. It belongs to the class of immune checkpoint inhibitors.

Investigated diseases

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.