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Study of Nivolumab and Ipilimumab for Patients with Stage 3 Non-Small Cell Lung Cancer Not Suitable for Surgery

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 treatments for non-small cell lung cancer (NSCLC), specifically in cases where the cancer is locally advanced and has not been treated before. The study involves several medications, including nivolumab, ipilimumab, and durvalumab. These medications are used in combination with a treatment method called chemoradiotherapy, which combines chemotherapy and radiation therapy. The purpose of the study is to compare the effectiveness of different treatment combinations in improving the time patients live without the cancer getting worse.

Participants in the study will be randomly assigned to one of three groups. One group will receive nivolumab with chemoradiotherapy followed by nivolumab and ipilimumab. Another group will receive nivolumab with chemoradiotherapy followed by more nivolumab. The third group will receive chemoradiotherapy followed by durvalumab. The study will monitor how long patients live without the cancer progressing, as well as overall survival and response to the treatment.

The trial is designed to last several years, with regular check-ups and assessments to track the progress of the disease and the effects of the treatments. The study aims to provide valuable information on the best treatment options for patients with this type of lung cancer, potentially leading to improved outcomes and quality of life for those affected by the disease.

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, you will be assigned to one of the treatment groups. This assignment is random, meaning it is done by chance, like flipping a coin.

    You will be informed about the specific treatment plan you will follow, including the medications and procedures involved.

  2. Step 2

    Treatment initiation

    The treatment will begin with a combination of medications and possibly radiation therapy, depending on your assigned group.

    Medications such as nivolumab, ipilimumab, durvalumab, carboplatin, cisplatin, etoposide, paclitaxel, and pemetrexed may be used. These are given through an intravenous (IV) line, which means they are delivered directly into your bloodstream.

  3. Step 3

    Medication schedule

    The frequency and duration of medication administration will vary based on the specific treatment group you are in.

    You will receive detailed instructions on how often you will need to visit the clinic for your treatments and any additional procedures.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, regular monitoring will be conducted to assess your health and the effectiveness of the treatment.

    This will include physical exams, blood tests, and imaging tests such as CT scans to track the progress of the treatment.

  5. Step 5

    Follow-up visits

    After completing the treatment phase, follow-up visits will be scheduled to continue monitoring your health.

    These visits are important to ensure any long-term effects of the treatment are managed appropriately.

  6. Step 6

    End of trial

    The trial is expected to conclude by December 2026, but your participation may end earlier depending on your treatment plan and health status.

    You will be informed about the results of the trial and any further steps that may be necessary for your care.

Who can join the trial?

7 criteria

  • Must have **previously untreated** locally advanced non-small cell lung cancer (LA NSCLC).
  • Must have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 or 1. This is a scale used to assess how a patient's disease is progressing, including their level of functioning and ability to care for themselves.
  • Cancer must be at a **locally advanced stage IIIA, IIIB, or IIIC**. This means the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body.
  • Must be **newly diagnosed** and have not received any prior local or systemic anticancer therapy for the locally advanced disease. This means no previous treatments like chemotherapy or radiation for this condition.
  • Open to both **male and female** participants.
  • Participants must be within the specified **age range** for the study.
  • Includes individuals from **vulnerable populations**, which may refer to groups who might need special consideration or protection in research settings.

Who cannot join the trial?

10 criteria

  • Patients who have already received treatment for their lung cancer cannot participate.
  • Patients with other types of cancer besides non-small cell lung cancer are not eligible.
  • Patients with serious heart problems are excluded.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, such as a severe cold or flu, are not allowed.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to medications are excluded.
  • Patients who are unable to follow the study procedures or attend regular check-ups are not eligible.
  • Patients with a history of drug or alcohol abuse may be excluded.
  • Patients with certain autoimmune diseases, where the immune system attacks the body, cannot join.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used in combination with other treatments to help treat locally advanced non-small cell lung cancer.

  • Ipilimumab

    is another immune checkpoint inhibitor. It helps boost the immune system's response against cancer cells. In this study, it is used alongside Nivolumab to enhance the body's ability to fight lung cancer.

  • Durvalumab

    is also an immune checkpoint inhibitor. It helps the immune system detect and destroy cancer cells. In this trial, it is used after chemoradiotherapy to help prevent the cancer from progressing.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating previously untreated, locally advanced non-small cell lung cancer (LA NSCLC). The main therapeutic use of Nivolumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

  • Ipilimumab

    Ipilimumab is also given as an intravenous infusion. It is being tested in combination with Nivolumab for its potential to treat LA NSCLC. The primary therapeutic indication for Ipilimumab is to enhance the immune system's ability to fight cancer. It works by blocking a protein called CTLA-4, which can inhibit the immune response against cancer cells. Ipilimumab is classified as an immune checkpoint inhibitor, similar to Nivolumab.

  • Durvalumab

    Durvalumab is administered through an intravenous infusion. It is being compared to other treatments in clinical trials for its role in treating LA NSCLC. The main therapeutic indication for Durvalumab is to support the immune system in targeting and destroying cancer cells. It functions by blocking the PD-L1 protein, which can help cancer cells evade the immune system. Durvalumab is also classified as an immune checkpoint inhibitor, focusing on enhancing the body's natural defenses against cancer.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow and form tumors, which can invade nearby tissues and organs. As it advances, it may cause symptoms like persistent cough, chest pain, and difficulty breathing. The progression can vary depending on the subtype and stage at diagnosis. Over time, it may lead to complications such as pleural effusion or metastasis to distant organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502886-71-00Protocol codeCA209-73LEstimated enrolment1 184 patientsSponsorBristol Myers Squibb International Corporation

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