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Study of Cemiplimab and Chemotherapy Combination for Patients with Advanced 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 the treatment of Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer. The study involves the use of several medications, including Cemiplimab, which is an anti-PD-1 antibody, and a combination of platinum-based chemotherapy drugs such as Paclitaxel, Cisplatin, Pemetrexed, Carboplatin, and Ipilimumab (also known by code names like BMS734016, HLX13, and IBI310). These medications are administered as solutions for infusion, meaning they are given directly into the bloodstream through an IV.

The purpose of this study is to compare the effectiveness of different combinations of these treatments in improving the overall survival of patients with advanced or metastatic NSCLC. The study is divided into two parts. In the first part, the effectiveness of cemiplimab combined with chemotherapy is compared to chemotherapy alone in patients whose tumors express a protein called PD-L1 in less than 50% of tumor cells. In the second part, the study compares cemiplimab with chemotherapy to a placebo with chemotherapy, regardless of PD-L1 expression.

Participants in the study will receive treatment over a period of time, with regular monitoring to assess their response to the treatment. The study aims to gather information on how well these treatments work in extending the life of patients with NSCLC and to observe any side effects that may occur. The study will also look at the quality of life of participants during the treatment period.

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, participation is confirmed for individuals with advanced or metastatic non-small cell lung cancer (NSCLC).

    Eligibility is based on specific criteria, including the type and stage of cancer, and previous treatments.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and cancer progression.

    This includes imaging tests such as CT or MRI scans to identify measurable lesions.

  3. Step 3

    Treatment allocation

    Participants are randomly assigned to different treatment groups.

    The study involves combinations of cemiplimab and platinum-based chemotherapy, with or without ipilimumab.

  4. Step 4

    Treatment administration

    Treatment is administered through IV infusion.

    Medications include paclitaxel, cisplatin, pemetrexed, ipilimumab, carboplatin, and cemiplimab.

    The specific combination and dosage depend on the assigned group.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess treatment effectiveness and side effects.

    This includes periodic imaging tests and health evaluations.

  6. Step 6

    End of treatment

    The treatment phase concludes as per the study protocol or if significant side effects occur.

    Participants may continue to be monitored for overall survival and quality of life.

Who can join the trial?

9 criteria

  • Patients must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC), which can be either squamous or non-squamous.
  • The cancer must be at an advanced stage, specifically stage IIIB, IIIC, or IV. Stage IV means the cancer has spread to other parts of the body.
  • Patients should not have received prior treatment with a combination of chemotherapy and radiation that aims to cure the cancer.
  • A sample of the tumor tissue must be available. This sample should be from a site where the cancer has spread or returned and should not have been treated with radiation before.
  • For Part 1 of the study, the tumor must show less than 50% of a protein called PD-L1 in the cancer cells. This is determined by a special test done in a central laboratory.
  • There must be at least one area of cancer that can be measured using imaging tests like CT (Computed Tomography) or MRI (Magnetic Resonance Imaging). If the area has been treated with radiation before, there must be proof that the cancer is growing there again.
  • Patients must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale. This scale measures how well patients can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Patients should have an expected life expectancy of at least 3 months.
  • Other specific criteria defined in the study protocol may also apply.
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Investigated drugs

  • Cemiplimab

    is a medication used in this trial as an anti-PD-1 antibody. It helps the immune system recognize and attack cancer cells, particularly in patients with advanced non-small cell lung cancer. It is being tested in combination with chemotherapy to see if it improves survival rates.

  • Platinum-based Doublet Chemotherapy

    is a standard treatment for advanced non-small cell lung cancer. It involves using two chemotherapy drugs, one of which contains platinum, to kill cancer cells and stop them from growing. This therapy is being used as a comparison to see how well the new combinations work.

  • Ipi

    , also known as ipilimumab, is another medication used in the trial. It is an immune checkpoint inhibitor that works by helping the immune system attack cancer cells more effectively. It is being tested in combination with cemiplimab and chemotherapy to evaluate its effectiveness in improving patient outcomes.

What is already known about the treatment

Cemiplimab – Cemiplimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced non-small cell lung cancer. It is an anti-PD-1 antibody, which means it works by blocking the PD-1 protein on immune cells, helping the immune system to better recognize and attack cancer cells. This medication is classified as an immune checkpoint inhibitor and is being evaluated for its potential to improve overall survival in patients with this type of lung 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 starts in the epithelial cells lining the lungs and can be classified into subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The disease often progresses slowly compared to small cell lung cancer, but it can spread to other parts of the body if not managed. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the cancer advances, it may lead to more severe respiratory issues and general health decline. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515051-38-00Protocol codeR2810-ONC-16113Estimated enrolment790 patientsSponsorRegeneron Pharmaceuticals Inc.

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