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Study of Chemotherapy and Nivolumab for Patients with Locally Advanced Non-Small Cell Lung Cancer

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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). The study is investigating the effects of combining chemotherapy with a type of treatment called immunotherapy, compared to using chemotherapy alone. The immunotherapy drug being used in this study is called nivolumab, which is also known by its code name BMS936558. Nivolumab is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to see if the combination of chemotherapy and immunotherapy can lead to a better response in patients with NSCLC that is located in the chest and can potentially be removed by surgery. The study will compare the presence of any remaining cancer in the lungs and lymph nodes between patients receiving the combination treatment and those receiving only chemotherapy. Participants in the study will receive treatment over a period of time, and their health will be monitored to assess the effectiveness and safety of the treatments.

Throughout the study, researchers will also look at other important factors such as overall survival, how long patients live without the cancer getting worse, and the rate of significant responses to the treatment. They will also examine how the treatment affects the need for surgery, the length of hospital stays, and any side effects related to the surgery. The study aims to provide valuable information on how well the combination of chemotherapy and immunotherapy works for treating NSCLC and to understand the relationship between the treatment and the type of lung cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the investigational nature of the trial and will sign a written informed consent.
Eligibility criteria include being over 18 years old, having a confirmed diagnosis of non-small cell lung cancer (NSCLC) at stage IIIA or IIIB, and having a tumor considered resectable by a multidisciplinary team.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm measurable or evaluable disease according to specific criteria.
A performance status evaluation will be conducted to ensure the patient is capable of proper therapeutic compliance.
Step 3
Treatment phase
The treatment phase involves receiving either a combination of chemotherapy and immunotherapy or chemotherapy alone.
The immunotherapy used is nivolumab, administered as an intravenous infusion. The specific dosage and frequency will be determined by the study protocol.
Step 4
Monitoring and follow-up
Throughout the treatment, the patient will be monitored for any adverse events and the effectiveness of the treatment.
Regular follow-up visits will be scheduled to assess the patient's response to the treatment and to ensure safety and tolerability.
Step 5
Surgery evaluation
After the treatment phase, the patient will be evaluated to determine if surgery is feasible.
The primary goal is to achieve a pathological complete response, which means no residual tumor in the lung and lymph nodes.
Step 6
Post-surgery follow-up
If surgery is performed, the patient will be monitored for recovery and any potential complications.
The study will continue to follow the patient's overall survival and progression-free survival, as well as other secondary endpoints.

Who can join the trial?

10 criteria

Patients must have **non-small cell lung cancer (NSCLC)** that has not been treated before.
The cancer should be at **stage IIIA** or **stage IIIB** with specific characteristics, meaning it is advanced but still possibly removable by surgery.
The tumor must be considered **resectable**, which means it can be surgically removed, as determined by a team of medical experts.
Patients should 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 have normal **blood, liver, and kidney function**.
Participants must be informed about the study and sign a **written informed consent**, agreeing to participate.
Patients must be **over 18 years old**.
Women who can have children must have a **negative pregnancy test** before starting the treatment.
All sexually active men and women who can have children must use an **effective birth control method** during the study and for at least 12 months after the last treatment.
Patients must be able to follow the treatment plan correctly and be available for follow-up visits.

Who cannot join the trial?

10 criteria

Patients with other types of cancer besides non-small cell lung cancer (NSCLC) cannot participate. NSCLC is a common type of lung cancer.
Patients who have had previous treatments that might interfere with the study results are not eligible.
Patients with serious health conditions that could make participation unsafe are excluded.
Patients who are unable to follow the study procedures or attend required visits cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who have allergies or reactions to the study medications are excluded.
Patients who are part of another clinical trial at the same time cannot participate.
Patients with a history of drug or alcohol abuse that could affect the study are not eligible.
Patients who have had a recent major surgery or are planning to have surgery during the study period are excluded.
Patients with certain infections that could interfere with the study are not allowed to participate.

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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
Complexo Hospitalario Universitario De Vigo
Responsive
Vigo, Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

Chemo-immunotherapy
is a combination treatment that uses both chemotherapy and immunotherapy to fight cancer. Chemotherapy involves using drugs to kill cancer cells or stop them from growing. Immunotherapy helps the body's immune system recognize and attack cancer cells more effectively. In this trial, chemo-immunotherapy is being tested to see if it can improve outcomes for patients with locally advanced non-small cell lung cancer.
Chemotherapy
is a treatment that uses powerful drugs to kill cancer cells or stop them from growing and dividing. It is a standard treatment for many types of cancer, including non-small cell lung cancer. In this trial, chemotherapy is being used alone to compare its effectiveness against the combination of chemo-immunotherapy.

Nivolumab

What is already known about the treatment

Nivolumab – Nivolumab is administered intravenously, typically as an infusion over a set period. It is currently well-documented in medical literature and is approved for use in various cancers, including non-small cell lung cancer (NSCLC). The main therapeutic indication for Nivolumab in this context is to enhance the immune system's ability to fight cancer cells. At the molecular level, it works by blocking the PD-1 protein on immune cells, preventing cancer cells from evading immune detection. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Non-small cell lung cancer (NSCLC) – This is the most common type of lung cancer, accounting for about 85% of all cases. It typically begins in the epithelial cells lining the lungs and can spread to other parts of the body. NSCLC progresses through stages, starting from a localized tumor to more advanced stages where it may invade nearby tissues or spread to distant organs. The disease is often categorized into subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, based on the type of cells involved. Symptoms may include a persistent cough, chest pain, and shortness of breath, but they often appear only after the disease has advanced. Early detection is challenging, as initial stages may not present noticeable symptoms.