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Study on the Safety and Effectiveness of Fianlimab, Cemiplimab, and Chemotherapy in Adults 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) that can be treated with surgery. The trial aims to evaluate the safety and effectiveness of a combination of medications. These include Fianlimab and Cemiplimab, which are proteins designed to help the immune system fight cancer, and various chemotherapy drugs such as Paclitaxel, Carboplatin, Cisplatin, and Pemetrexed. Some patients will receive a combination of Fianlimab, Cemiplimab, and chemotherapy, while others will receive Cemiplimab with chemotherapy. A placebo may also be used in the study.

The purpose of the study is to determine if the combination of Fianlimab, Cemiplimab, and chemotherapy is more effective than Cemiplimab with chemotherapy alone in treating patients with resectable early-stage NSCLC. The study will involve a series of treatments administered through an intravenous (IV) infusion, which means the medication is given directly into a vein. The treatment period can last up to 54 weeks, depending on the specific combination of drugs being tested.

Throughout the study, participants will be closely monitored to assess how well the cancer responds to the treatment and to identify any side effects. The study will also look at how the treatment affects the ability to perform surgery and the overall health and quality of life of the participants. The trial is designed to provide valuable information that could improve treatment options for patients with NSCLC in the future.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the trial, an initial assessment is conducted to confirm eligibility. This includes a physical examination and imaging studies to ensure there is no evidence of cancer spread beyond the lungs.

    A test is performed to evaluate the presence of a specific protein, PD-L1, which is important for determining treatment suitability.

  2. Step 2

    Treatment phase 1

    The first phase of treatment involves the administration of cemiplimab and fianlimab in combination with chemotherapy. These medications are given through an intravenous (IV) infusion.

    The chemotherapy drugs used may include paclitaxel, carboplatin, cisplatin, and pemetrexed. The specific combination and dosage depend on individual treatment plans.

  3. Step 3

    Surgery

    After completing the initial treatment phase, surgery is performed to remove the lung tumor. The type of surgery depends on the tumor's location and size.

    The goal of surgery is to achieve a complete removal of the tumor, which is evaluated by examining the tissue after surgery.

  4. Step 4

    Post-surgery assessment

    Following surgery, a detailed assessment is conducted to evaluate the response to treatment. This includes a pathological review of the removed tumor tissue.

    The assessment helps determine the effectiveness of the treatment and guides any further therapy needed.

  5. Step 5

    Follow-up

    Regular follow-up visits are scheduled to monitor recovery and check for any signs of cancer recurrence.

    These visits may include physical exams, imaging tests, and blood tests to ensure ongoing health and address any side effects from treatment.

Who can join the trial?

7 criteria

  • Patients must have a newly diagnosed type of lung cancer called Non-small Cell Lung Cancer that can be completely removed by surgery.
  • If there is evidence of enlarged lymph nodes in the chest area on imaging tests, a sample of these lymph nodes must be taken.
  • Patients must not have cancer that has spread to other parts of the body, confirmed by a physical exam and imaging tests done within 4 weeks before starting the study.
  • Patients need to have a test result for a protein called PD-L1, which is checked using a method called immunohistochemistry (IHC).
  • Patients should have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well they can carry out daily activities.
  • Patients must have proper functioning of their bone marrow, liver, and kidneys.
  • Other specific criteria defined in the study protocol must also be met.

Who cannot join the trial?

11 criteria

  • Patients with any other type of cancer that is not the specific type being studied.
  • Patients who have had previous treatment for their lung cancer, such as surgery, chemotherapy, or radiation.
  • Patients with serious heart problems, like heart failure or a recent heart attack.
  • Patients with uncontrolled high blood pressure.
  • Patients with active infections that need treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of severe allergic reactions to similar medications.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body.
  • Patients who are taking medications that affect the immune system.
  • Patients with a history of drug or alcohol abuse.
  • Patients with any other medical condition that the study doctors think would make it unsafe to participate.
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Investigated drugs

  • Fianlimab

    is an investigational medication being studied for its potential to help the immune system fight cancer. In this trial, it is used in combination with other treatments to see if it can improve outcomes for patients with certain types of lung cancer.

  • Cemiplimab

    is a medication that helps the immune system recognize and attack cancer cells. It is used in this trial to see if it can be effective in treating patients with early-stage lung cancer when combined with chemotherapy.

  • Chemotherapy

    refers to a group of medications that are used to kill or slow the growth of cancer cells. In this trial, chemotherapy is combined with other treatments to evaluate its effectiveness in treating early-stage lung cancer.

What is already known about the treatment

  • Fianlimab

    Fianlimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating resectable non-small cell lung cancer (NSCLC). It is being evaluated in combination with cemiplimab and chemotherapy. The main therapeutic indication is for patients with early-stage NSCLC that can be surgically removed. Fianlimab works by targeting specific proteins on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.

  • Cemiplimab

    Cemiplimab is given through intravenous infusion and is under investigation in clinical trials for its role in treating resectable non-small cell lung cancer (NSCLC). It is used in combination with chemotherapy and sometimes with fianlimab. The primary therapeutic use is for patients with early-stage NSCLC that is operable. Cemiplimab functions by blocking a protein that inhibits immune responses, thereby boosting the immune system's ability to fight cancer. It belongs to the class of immune checkpoint inhibitors.

Investigated diseases

Non-small Cell Lung Cancer – Non-small cell lung cancer (NSCLC) 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 all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can progress to invade nearby tissues and organs. As it advances, it may spread to lymph nodes and other parts of the body. Early stages may not show symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath may occur.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505172-29-00Protocol codeR3767-ONC-2266Estimated enrolment202 patientsSponsorRegeneron Pharmaceuticals Inc.

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