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Study of Chemotherapy and Nivolumab Before and After Surgery for Patients with Non-Small Cell Lung Cancer in the Upper Lung Area

Verified siteRegistered drugNo placebo

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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), specifically when the tumor is located in the upper part of the lungs, called a Pancoast tumor. The study involves a treatment approach that combines chemotherapy and a type of immunotherapy using a medication called nivolumab, which is also known by its code name BMS936558. This treatment is given before and after surgery to remove the tumor.

The purpose of the study is to evaluate how effective this combined treatment is in completely removing the tumor without any remaining cancer cells. Participants will receive chemotherapy and nivolumab before surgery, known as neoadjuvant treatment, and may continue with additional treatment after surgery, depending on the results of the surgery. The study aims to see if this approach can improve the chances of a complete tumor removal and to monitor the overall health and survival of the participants over time.

Throughout the study, participants will be closely monitored for their response to the treatment and any side effects they may experience. The study will also look at how long participants live without the cancer coming back and how their bodies respond to the treatment. This research is important for understanding how to better treat NSCLC with Pancoast tumors and improve outcomes for patients with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed through various tests, including a PET/CT scan and possibly a brain scan. These tests ensure the absence of distant disease and confirm the presence of a Pancoast tumor.
A negative pregnancy test is required for women of childbearing potential. All participants must agree to use effective contraception during the study and for 12 months after the last dose of trial drugs.
Step 2
Induction Treatment
The initial phase involves chemotherapy combined with nivolumab, an immunotherapy drug. Nivolumab is administered as a solution for infusion through a vein (intravenous use).
The goal of this phase is to reduce the tumor size and achieve a complete resection, meaning no residual tumor remains.
Step 3
Surgery
Following the induction treatment, surgery is performed to remove the tumor. The success of the surgery is evaluated based on the absence of any remaining tumor tissue.
Step 4
Adjuvant Treatment
After surgery, additional treatment may be provided depending on the results of the surgery. This phase aims to eliminate any remaining cancer cells and prevent recurrence.
Step 5
Follow-up
Regular follow-up visits are scheduled to monitor health status and detect any signs of cancer returning. These visits include various assessments to evaluate overall survival and disease-free survival over a period of 24 months.

Who can join the trial?

21 criteria

Patients must have **non-small cell lung cancer** with a **Pancoast tumor** that can be surgically removed. This type of cancer is located at the top of the lung.
Patients should not have received any previous treatment for this cancer.
Patients must be informed about the study and sign a consent form agreeing to participate.
Women who can have children must have a negative pregnancy test before joining the study.
All sexually active men and women who can have children must use effective birth control during the study and for 12 months after the last treatment.
Patients must be able to follow the treatment plan and attend follow-up appointments.
A **PET/CT scan** with contrast and a brain scan must be done before joining to check for cancer spread. A PET/CT scan is a special imaging test that helps to see how the body is working.
If the **mediastinal lymph nodes** (lymph nodes in the chest area) show cancer on the PET/CT scan, it must be confirmed with a tissue sample. If there is a large mass of lymph nodes, a sample may not be needed.
The cancer must be measurable or able to be evaluated using specific criteria called **RECIST 1.1**.
Patients must have an **ECOG performance status** of 0 to 2, which means they are fully active or have some limitations but can still take care of themselves.
Patients should have a life expectancy of more than 12 weeks.
Patients must be between 18 and 75 years old.
Blood tests must show certain levels, such as:
- **Neutrophils** (a type of white blood cell) must be at least 1500 per microliter.
- **Platelets** (cells that help with blood clotting) must be at least 100,000 per microliter.
- **Hemoglobin** (a protein in red blood cells) must be more than 10.0 grams per deciliter.
- **Serum creatinine** (a waste product in the blood) must be within a certain range, or **creatinine clearance** must be at least 40 mL/min, which measures kidney function.
- **AST/ALT** (liver enzymes) must be within a certain range.
- **Total bilirubin** (a substance made by the liver) must be within a certain range, except for those with **Gilbert Syndrome**, who can have higher levels.
- **Forced expiratory volume (FEV1)** must be at least 1.2 liters or more than 40% of the predicted value, which measures lung function.
- **INR/APTT** (blood clotting tests) must be within normal limits.
- Patients must have good lung function without using bronchodilators, with FEV1 and **DLCO** (a test that measures how well the lungs transfer gas) both over 40% of the predicted normal value.

Who cannot join the trial?

10 criteria

Patients who have a type of lung cancer that cannot be surgically removed.
Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had another type of cancer in the past, unless it was successfully treated and has not returned.
Patients who are currently participating in another clinical trial.
Patients who have an allergy to any of the study medications.
Patients who have an active infection that requires treatment.
Patients who have a history of severe heart problems.
Patients who have a history of autoimmune diseases, which are conditions where the immune system attacks the body.
Patients who have received a live vaccine within 30 days before starting the study.

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Verified sites

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

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain
Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario De Jaen
Responsive
Jaen, Spain

Trial locations

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Investigated drugs

Nivolumab
is an immunotherapy medication used in this trial. It works by helping the body's immune system recognize and attack cancer cells more effectively. In this study, it is used in combination with chemotherapy to treat patients with a specific type of lung cancer known as a pancoast tumor.
Chemotherapy
involves the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is given before surgery to shrink the tumor and increase the chances of a successful removal. The specific drugs used in the chemotherapy regimen are not detailed, but they are part of the standard treatment for lung cancer.

Nivolumab

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating resectable non-small cell lung cancer, specifically Pancoast tumors. The main therapeutic indication for nivolumab is its use as an immunotherapy to enhance the body's immune response against cancer cells. At the molecular level, nivolumab works by blocking the PD-1 protein on immune cells, which helps to activate the immune system to attack cancer cells. It is classified as a monoclonal antibody and is part of the broader category of immune checkpoint inhibitors.

Investigated diseases

Non-small cell lung cancer Pancoast tumor – This is a type of lung cancer that occurs at the top of the lung and can invade nearby tissues such as the ribs and vertebrae. It is a subtype of non-small cell lung cancer, which is the most common type of lung cancer. The tumor can cause shoulder pain, arm pain, and muscle weakness due to its location. As it progresses, it may lead to more severe symptoms like Horner's syndrome, which includes drooping eyelids and reduced sweating on one side of the face. The disease typically advances by spreading to nearby lymph nodes and potentially to other parts of the body. Early detection and treatment are crucial to managing its progression.