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

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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), 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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Clinico San Carlos	Madrid	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain

Other Sites

Site Name	City	Country
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitari Dexeus Grupo Quironsalud	Barcelona	Spain
Consorci Sanitari Del Maresme	Mataró	Spain
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Universitario De Jaen	Jaen	Spain
Hospital Universitario Dr Peset Aleixandre	Valencia	Spain
Hospital Clinico Universitario De Valladolid	Valladolid	Spain
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada	Manresa	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Hospital Alvaro Cunqueiro	Vigo	Spain
Servei De Salut De Les Illes Balears	Palma	Spain
Puvu Tweem Hcwagxqh Uqvrnendufgy	Sabadell	Spain
Flgqnbasx Pydh La Iujfofoaekmjz Bywmteqml Dkm Hpymbvig Ushdpkuhitrvi Lf Paq	Madrid	Spain
Huuipymi Vnyd dgtofxcy	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	12.05.2023

Trial locations

Investigated drugs:

Nivolumab

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.

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.

Trial ID:

2024-512359-19-00

NCT ID:

NCT05684276

Trial Phase:

Therapeutic exploratory (Phase II)

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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

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