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Study of Nivolumab and Relatlimab for Patients with Resectable 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), specifically in its early stages or when it is locally advanced. The study is exploring the use of two medications: nivolumab and relatlimab. Nivolumab is already known for its use in cancer treatment, while relatlimab is being tested in combination with nivolumab to see if it can improve treatment outcomes.

The purpose of the study is to determine if a four-week course of these medications before surgery is feasible for patients with NSCLC who are eligible for surgery aimed at curing the cancer. During the study, participants will receive either nivolumab alone or a combination of nivolumab and relatlimab. These medications are given through an injection into a vein, known as an intravenous injection. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

The study will monitor how well patients respond to the treatment and whether they can proceed to surgery within a set timeframe. It will also look at the safety and side effects of the treatment. The goal is to find the best combination of these medications and understand how they affect the immune system's response to cancer. This research could help improve treatment strategies for patients with NSCLC in the future.

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, eligibility is confirmed based on specific criteria, including a diagnosis of non-small cell lung cancer (NSCLC) at certain stages.
A written informed consent is required to participate in the study.
Step 2
Pre-treatment assessment
Before starting treatment, a series of assessments are conducted to ensure suitability for the study. These include imaging studies to exclude extensive metastases and confirm measurable tumors.
Pulmonary function tests and cardiac assessments are performed to ensure the ability to undergo surgery.
Step 3
Treatment phase
The treatment involves a four-week course of preoperative immunotherapy.
Medications used include nivolumab and relatlimab, administered intravenously.
The dosage and combination of these medications may vary, and they are given as a solution for injection or infusion.
Step 4
Surgery
Following the immunotherapy, surgery is planned within 43 days to remove the lung cancer.
The goal is to perform a curative resection, which means removing all visible cancer.
Step 5
Post-surgery follow-up
After surgery, follow-up assessments are conducted to monitor recovery and evaluate the response to treatment.
These assessments include checking for any remaining cancer and monitoring overall health and recovery.
Step 6
Long-term monitoring
The study includes monitoring for disease-free survival and overall survival at 12 months.
Safety and tolerability of the treatment are also evaluated during this period.

Who can join the trial?

11 criteria

Patients must have **non-small cell lung cancer (NSCLC)** confirmed by a biopsy. This type of lung cancer is in specific stages: IB, II, and some cases of stage III A.
Patients must be able to have surgery to remove the cancer.
Patients must be able and willing to sign a form agreeing to participate in the study and follow the study rules and surgery plans.
Both men and women who are 18 years or older can participate.
Women who can have children must have a negative pregnancy test before starting the study and must agree to use effective birth control during the study and for 5 months after the last dose of the study drug.
Patients must have an **ECOG** score of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
Patients must not have cancer spread to many lymph nodes in the chest or to other parts of the body, as shown by imaging tests like PET/CT or MRI.
Patients must have a tumor that can be measured using standard imaging techniques before starting the study treatment.
Patients must have good lung function to safely undergo lung cancer surgery. This includes specific measurements like **ppFEV1** greater than 30%, **ppDLCO** greater than 30%, and **ppVO2max** of at least 10 ml/min/kg if required by local guidelines.
Patients must have adequate blood, liver, and kidney function.
Patients must have a healthy heart with a **left ventricular ejection fraction (LVEF)** of 50% or higher, as shown by an echocardiogram or a similar test within 6 months before starting the study drug.

Who cannot join the trial?

4 criteria

Patients with a different type of cancer other than non-small cell lung cancer (NSCLC) in the specified stages.
Patients who are not eligible for surgery aimed at curing the cancer.
Patients who are younger than 18 years old or older than 65 years old.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Jessa Ziekenhuis
Verified
Hasselt, Belgium
Thoraxklinik Heidelberg gGmbH
Responsive
Heidelberg, Germany
Universitaetsklinikum Essen AöR
Verified
Essen, Germany

Trial locations

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Investigated drugs

Nivolumab
is a type of immunotherapy used in this trial. It works by helping the immune system recognize and attack cancer cells. It is being tested to see if it can be effective when given before surgery to patients with early-stage or locally advanced non-small cell lung cancer.
Relatlimab
is another immunotherapy drug used in combination with nivolumab in this trial. It is designed to enhance the immune response against cancer cells. The study aims to find out if using relatlimab together with nivolumab can improve treatment outcomes for patients with non-small cell lung cancer who are eligible for surgery.

What is already known about the treatment

Nivolumab
Nivolumab is administered as an intravenous infusion, typically given in a hospital or clinical setting. It is currently approved and widely used in the treatment of various cancers, including non-small cell lung cancer (NSCLC). The main therapeutic indication for nivolumab in this context is for patients with resectable NSCLC in early or locally advanced stages. At the molecular level, nivolumab 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.
Relatlimab
Relatlimab is also administered via intravenous infusion, often in combination with other medications like nivolumab. It is under investigation in clinical trials for its potential use in treating cancers such as non-small cell lung cancer. The primary therapeutic indication is to enhance the immune response in patients with resectable NSCLC. Relatlimab functions by targeting the LAG-3 protein on immune cells, which helps to further stimulate the immune system to attack cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath may develop. The disease is often diagnosed at a more advanced stage when it has spread to other parts of the body. Treatment options and outcomes can vary depending on the stage and specific characteristics of the cancer.