Not recruiting

Study on Re-Challenging Advanced Lung Cancer with Cemiplimab After Initial Treatment with Ipilimumab and Radiotherapy

Registered 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 advanced non-small cell lung cancer (NSCLC). The study involves patients who have previously received treatment targeting a protein called PD-1 but have not responded as hoped. The trial will explore the effects of two medications: cemiplimab (also known by its code name REGN2810) and ipilimumab (also known by its code name BMS734016). These medications are given as solutions through an intravenous (IV) infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to see if reintroducing cemiplimab after initial treatment with ipilimumab and additional radiotherapy can help control the cancer. Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. The study will monitor how well the cancer responds to this combination of treatments over time. Some participants will receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

Participants in the study will receive the treatments over a period of time and will be regularly monitored to assess their response. The study aims to determine if the cancer shows a complete or partial response, meaning it shrinks or disappears, or if it remains stable without growing for at least six months. The safety of the treatments and any side effects will also be closely observed. The trial is expected to continue until 2025, providing valuable information on the potential benefits of this treatment approach for patients with advanced NSCLC.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
A blood test is performed to ensure adequate organ function. This test must be completed within 14 days before starting treatment.
Step 2
Pregnancy test
For female participants of childbearing potential, a pregnancy test is required within 72 hours before receiving the first dose of study medication.
If the urine test is positive or inconclusive, a blood test will be necessary.
Step 3
Tissue biopsy
A tissue sample is obtained from a tumor lesion for analysis. This is done through a procedure called a biopsy.
A second biopsy may be required from a non-irradiated lesion after radiation and immune-modulating treatment.
Step 4
Treatment initiation
The treatment begins with the administration of ipilimumab through an intravenous (IV) infusion. The dosage and frequency are determined by the study protocol.
Following the initial treatment, cemiplimab is introduced as a re-challenge therapy. This is also administered via IV infusion starting on Day 1 of Week 27.
Step 5
Radiotherapy
Radiotherapy is applied to one of the metastatic lesions to boost the immune response.
This step is part of the immune-boosting strategy in the study.
Step 6
Follow-up assessments
Regular follow-up assessments are conducted to monitor the response to treatment. This includes imaging tests to evaluate tumor size and progression.
The primary goal is to achieve a clinical benefit rate, which includes complete or partial response or stable disease lasting at least 6 months after re-introduction of PD-1 inhibition.
Step 7
End of study
The study is estimated to conclude by September 2025. Participants will continue to be monitored for safety and efficacy of the treatment until the end of the study.
Final assessments will be conducted to determine the overall response and any long-term effects of the treatment.

Who can join the trial?

12 criteria

Have a proven diagnosis of recurrent advanced NSCLC (a type of lung cancer), regardless of the specific type of lung cancer.
If you are a female who can have children, you must have a negative pregnancy test within 72 hours before receiving the first dose of the study medication.
Female participants who can have children should agree to use two methods of birth control, be surgically sterile, or abstain from heterosexual activity during the study and for six months after the last dose of study medication.
Male participants should agree to use an adequate method of contraception starting with the first dose of study therapy and continuing for six months after the last dose.
Be willing and able to provide written informed consent to participate in the trial.
Be at least 18 years old on the day of signing the informed consent.
Must still have measurable disease based on RECIST 1.1 criteria after receiving study SBRT (a type of radiation therapy). Lesions that were treated with radiation before the study but have grown since then can be considered measurable.
Must provide a new tissue sample from a tumor biopsy and be willing to have a second biopsy from any non-irradiated lesion after radiation and immune-modulating treatment. This lesion may be used for RECIST measurements.
Have a performance status of 0 or 1 on the ECOG Performance Scale, which measures your ability to perform daily activities.
Have Stage IV NSCLC treated with at least PD-(L)1 blockade (a type of cancer treatment). There is no limit on the number of previous treatments. Patients with both primary or acquired resistance to PD-(L)1 inhibition may be eligible. However, specific numbers of patients need to meet the definition of acquired resistance in different stages of the study.
Have at least two separate (metastatic) lesions, with one eligible for irradiation and another for biopsy and RECIST tumor evaluation.
Demonstrate adequate organ function as defined in the study's criteria. All screening labs should be performed within 14 days of starting treatment.

Who cannot join the trial?

6 criteria

Patients who have not received previous treatment with anti-PD-(L)1. Anti-PD-(L)1 refers to a type of cancer treatment that helps the immune system fight cancer cells.
Patients with advanced NSCLC who have not progressed after previous anti-PD-(L)1 treatment. NSCLC stands for non-small cell lung cancer, a type of lung cancer.
Patients with a targetable driver mutation who have not exhausted all options for targeted therapy. A targetable driver mutation is a specific change in cancer cells that can be targeted with certain treatments.
Patients who have not shown progression on previous PD-(L)1 blockade. Progression means that the cancer has continued to grow or spread.
Patients who are not within the age range specified for the study.
Patients who are part of a vulnerable population, which means they may need special protection or care.

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Investigated drugs

Ipilimumab
is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells. In this trial, ipilimumab is used to "prime" or prepare your immune system to better fight against cancer.
Radiotherapy
is a treatment that uses high-energy rays, like X-rays, to kill cancer cells. In this trial, radiotherapy is used to "boost" the immune response, making it stronger and more effective in attacking cancer cells.
Anti-PD-1
therapy is another type of immune checkpoint inhibitor. It helps your immune system continue to attack cancer cells by blocking a specific pathway that cancer cells use to hide from the immune system. In this trial, anti-PD-1 therapy is reintroduced after the initial treatments to help maintain the immune system's attack on the cancer.

What is already known about the treatment

Ipilimumab – Ipilimumab is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently used in medicine to help treat certain types of cancer, including advanced non-small cell lung cancer (NSCLC), especially after other treatments have not worked. The main therapeutic indication for ipilimumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called CTLA-4, which normally helps keep the immune system in check, thereby boosting the body's immune response against cancer cells. Ipilimumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight 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 through stages, starting from localized tumors in the lungs to more advanced stages where it spreads to lymph nodes and other organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to more severe respiratory issues and systemic symptoms. The progression rate can vary, and it often depends on the specific subtype and individual patient factors.