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Study on the Safety and Effectiveness of Nivolumab, Pembrolizumab, and Cemiplimab with Radiotherapy for Stage IV Non-Small Cell Lung Cancer Patients

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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 stage IV non-small cell lung cancer, a type of lung cancer that has spread to other parts of the body. The study will explore the use of immunotherapy, which is a treatment that helps the body's immune system fight cancer. The medications being tested in this study include Opdivo (also known as nivolumab), Keytruda (also known as pembrolizumab), Libtayo (also known as cemiplimab), and Tecentriq (also known as atezolizumab). These medications are given as a solution through a vein, known as an infusion.

The purpose of the study is to evaluate how well these immunotherapy treatments work when combined with extensive radiotherapy, which is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. The study will look at the side effects that occur within the first six months of treatment. Participants will be randomly assigned to one of two groups: one group will receive immunotherapy with radiotherapy, and the other group will receive immunotherapy without radiotherapy. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatments.

The study will monitor participants over time to assess the safety and effectiveness of the treatments. This includes checking for any side effects and measuring how the cancer responds to the treatment. The study will also evaluate the quality of life of participants at different stages of the treatment. The results will help determine the best approach to treating stage IV non-small cell lung cancer with these immunotherapy drugs and radiotherapy.

The research process

The trial runs in 7 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, participation is confirmed through written informed consent. Eligibility is based on specific criteria, including a diagnosis of stage IV non-small cell lung cancer (NSCLC) and a life expectancy of more than three months.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the patient's health status. This includes a clinical examination and laboratory tests to ensure adequate organ function. A biopsy of a tumor lesion is required, and the disease must be measurable according to specific criteria.
Step 3
Treatment allocation
Patients are randomly assigned to one of two treatment groups. One group receives immunotherapy combined with extensive radiotherapy, while the other group receives immunotherapy alone.
Step 4
Immunotherapy administration
Immunotherapy is administered intravenously. The medications used may include nivolumab, pembrolizumab, cemiplimab, or atezolizumab. The specific medication, dosage, and frequency depend on the treatment plan assigned.
Step 5
Radiotherapy (if applicable)
For patients in the group receiving combined treatment, radiotherapy is administered to at least one tumor lesion. The schedule and duration of radiotherapy are determined by the treatment plan.
Step 6
Monitoring and follow-up
Patients are monitored for acute toxicity (less than three months) and subacute toxicity (three to six months). Regular assessments include evaluating adverse events, laboratory values, and response to treatment. Quality of life is also assessed at specific intervals.
Step 7
End of study participation
Study participation continues until the estimated end date of December 31, 2030, or until the patient completes the treatment protocol. Final assessments are conducted to evaluate the overall response and any long-term effects of the treatment.

Who can join the trial?

12 criteria

Have **Stage IV non-small cell lung cancer (NSCLC)**, which means the cancer has spread to other parts of the body.
Need to start treatment with **immunotherapy** (a type of treatment that helps your immune system fight cancer) alone or with **chemotherapy** (a treatment that uses drugs to kill cancer cells).
Women who can have children should use a **highly effective birth control method** during treatment and for at least 5 months after the last dose of immunotherapy to prevent pregnancy. This includes methods like hormonal contraception, intrauterine devices, male condoms, or other reliable methods.
Be able to understand and respond to oral and written information and answer questionnaires.
Have a **biopsy** (a small sample of tissue) available from a tumor lesion.
Have a **measurable disease** according to specific criteria called **RECIST 1.1**, which helps doctors assess how the cancer responds to treatment.
Have an **ECOG performance status** of 0-2, which means you are fully active or have some symptoms but can still take care of yourself.
Have a **life expectancy** of more than 3 months.
Have at least one tumor lesion that can be treated with **radiotherapy** (a treatment that uses high-energy rays to kill cancer cells).
Be over 18 years old.
Provide **written informed consent**, which means you agree to participate in the study after understanding all the details.
Have **adequate organ function**, which means your organs are working well enough based on clinical examination and lab tests. This includes having enough red blood cells, white blood cells, and good kidney and liver function.

Who cannot join the trial?

5 criteria

Patients with other types of cancer besides non-small cell lung cancer (Stage IV) cannot participate. Non-small cell lung cancer is a type of lung cancer that is not small cell.
Patients who are younger than 18 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
Patients who are not able to follow the study procedures or attend the required visits cannot participate.
Patients who have any medical condition that the study doctors think would make it unsafe for them to participate cannot join the study.

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Verified sites

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

Oslo Universitetssykehus HF
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Oslo, Norway
St. Olavs Hospital HF
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Trondheim, Norway
Sykehuset Innlandet HF
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Brumunddal, Norway

Trial locations

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Investigated drugs

Immunotherapy
is a type of cancer treatment that helps your immune system fight cancer. In this trial, it is used to treat patients with stage IV non-small cell lung cancer. The goal is to see how well the body tolerates this treatment and how effective it is when combined with radiotherapy.
Extensive Radiotherapy
is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this study, it is combined with immunotherapy to see if the combination is more effective in treating stage IV non-small cell lung cancer. The trial aims to assess the side effects and benefits of using these therapies together.

What is already known about the treatment

Immunotherapy – This medication is administered through intravenous infusion, allowing it to enter the bloodstream directly. It is currently being studied in clinical trials for its effectiveness and safety in treating stage IV non-small cell lung cancer. The main therapeutic indication is to enhance the body's immune response against cancer cells. At the molecular level, it works by targeting specific proteins on cancer cells or immune cells, helping the immune system recognize and attack cancer more effectively. It is classified as an immunomodulatory agent, which means it modifies the immune system's activity to fight cancer.

Investigated diseases

Non-small cell lung cancer (Stage IV) – This is a type of lung cancer that is characterized by the uncontrolled growth of cells in the lung tissues. Stage IV indicates that the cancer has spread beyond the lungs to other parts of the body, such as the bones, brain, or liver. The disease often progresses with symptoms like persistent cough, chest pain, and difficulty breathing. As the cancer advances, it may lead to weight loss, fatigue, and other systemic symptoms. The progression of the disease can vary, with some patients experiencing rapid changes, while others may have a slower course. The spread of cancer cells to distant organs is a key feature of this stage.