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Study Comparing Cemiplimab to Platinum-Based Chemotherapy for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer

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). The study is comparing the effectiveness of a new treatment called cemiplimab (also known by its code name REGN2810) with standard treatments that use platinum-based chemotherapy. Chemotherapy is a common cancer treatment that uses drugs to kill cancer cells. The standard chemotherapy drugs being compared in this study include pemetrexed, gemcitabine, paclitaxel, carboplatin, and cisplatin.

The purpose of the study is to see if cemiplimab can help patients live longer and delay the progression of their cancer compared to the standard chemotherapy treatments. Patients participating in the study will receive either cemiplimab or one of the standard chemotherapy drugs. The study will monitor the patients' overall survival, which means how long they live, and progression-free survival, which refers to the time during which the cancer does not get worse.

Participants will receive their assigned treatment through an intravenous (IV) infusion, which means the medication is given directly into a vein. The study will also look at other factors, such as the response of the cancer to the treatment, any changes in the patients' quality of life, and any side effects they may experience. The study aims to provide valuable information about the potential benefits of cemiplimab for patients with advanced or metastatic NSCLC.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) with certain characteristics.

    A sample of tumor tissue is required to confirm the presence of a specific protein (PD-L1) in at least 50% of tumor cells.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to receive either cemiplimab or a standard platinum-based chemotherapy.

    Cemiplimab is administered as an intravenous (IV) infusion.

  3. Step 3

    Cemiplimab administration

    Cemiplimab is given as an IV infusion at a dose of 350 mg.

    The infusion is administered every three weeks.

  4. Step 4

    Platinum-based chemotherapy administration

    Participants receiving chemotherapy may be given one of the following: pemetrexed, gemcitabine, paclitaxel, carboplatin, or cisplatin.

    These medications are also administered as IV infusions, with specific dosages and schedules depending on the drug.

  5. Step 5

    Monitoring and assessments

    Regular assessments are conducted to monitor the response to treatment and any side effects.

    These assessments include imaging tests to measure tumor size and blood tests to check overall health.

  6. Step 6

    Study duration

    The study is expected to continue until June 2025.

    Participants remain in the study as long as they benefit from the treatment and do not experience unacceptable side effects.

Who can join the trial?

9 criteria

  • Patients must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC), which is confirmed by specific medical tests.
  • The cancer must be at an advanced stage, specifically stage IIIB, IIIC, or stage IV, and patients should not have received certain treatments before.
  • A sample of the tumor tissue, either from a previous biopsy or a new one, must be available for testing. This sample should not have been treated with radiation before.
  • The tumor cells must show a certain level of a protein called PD-L1, which will be tested in a laboratory.
  • There must be at least one tumor that can be measured using imaging tests, according to specific guidelines called RECIST 1.1.
  • The patient must have a performance status of 0 or 1 on the ECOG scale, which means they are fully active or have some symptoms but can still do light work.
  • The patient should have a life expectancy of at least 3 months.
  • The patient must have organs and bone marrow that are working well enough to participate in the study.
  • Other specific criteria defined in the study protocol may also apply.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer other than Non-small Cell Lung Cancer.
  • Patients whose tumors do not express programmed cell death ligand-1 (PD-L1) in at least 50% of tumor cells. PD-L1 is a protein that can affect the immune system's ability to fight cancer.
  • Patients who are not in the age range specified for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • REGN2810 (cemiplimab)

    is an anti-PD-1 antibody used in this study to treat patients with advanced or metastatic non-small cell lung cancer (NSCLC). It works by blocking a pathway that cancer cells use to hide from the immune system, helping the body to recognize and attack the cancer cells.

  • Platinum-Based Chemotherapy

    is a standard treatment for advanced or metastatic non-small cell lung cancer. It involves using drugs that contain the metal platinum to damage the DNA of cancer cells, which can stop them from growing and dividing. This type of chemotherapy is often used as a first-line treatment to help control the spread of cancer.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-small cell lung cancer (NSCLC) with high PD-L1 expression. The medication works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. Cemiplimab is classified as an anti-PD-1 antibody, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Non-small Cell Lung Cancer – 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. The disease progresses through stages, starting from localized tumors to more advanced stages where cancer cells have spread to lymph nodes or other organs. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease advances, it can lead to more severe respiratory issues and general health decline. The progression and impact of the disease can vary significantly among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515052-20-00Protocol codeR2810-ONC-1624Estimated enrolment687 patientsSponsorRegeneron Pharmaceuticals Inc.

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