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Study on the Safety and Effectiveness of Azacitidine and Pembrolizumab for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer After Platinum Treatment

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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), which is locally advanced or has spread to other parts of the body. The study is designed for patients who have already received a specific type of chemotherapy called platinum-based treatment. The trial aims to evaluate the safety and effectiveness of a combination of two treatments: CC-486 (also known as oral azacitidine) and pembrolizumab, which is also referred to by its code name, MK-3475. Pembrolizumab is a medication that is given through an injection into a vein, while azacitidine is taken as a tablet by mouth.

The purpose of the study is to compare the effects of the combination of CC-486 and pembrolizumab against pembrolizumab with a placebo in patients with NSCLC. Participants in the study will be randomly assigned to receive either the combination treatment or pembrolizumab with a placebo. The study will monitor the participants over a period to assess how well the treatments work and to check for any side effects. The trial will help researchers understand if the combination of CC-486 and pembrolizumab can improve outcomes for patients with this type of lung cancer.

Throughout the study, participants will receive regular check-ups and monitoring to ensure their safety and to track the progress of their treatment. The study is expected to continue until 2025, providing valuable information on the potential benefits and risks of using CC-486 in combination with pembrolizumab for treating advanced NSCLC. This research could lead to new treatment options for patients with this challenging form of lung cancer.

The research process

The trial runs in 5 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, eligibility is confirmed based on specific criteria such as age, diagnosis of non-small cell lung cancer (NSCLC), and previous treatment history.
A tumor tissue sample is required to assess PD-L1 status, which helps in determining the suitability for the study.
Step 2
Randomization
Participants are randomly assigned to one of two groups: one receiving CC-486 (oral azacitidine) with pembrolizumab, and the other receiving pembrolizumab with a placebo.
This process ensures that the study results are unbiased and reliable.
Step 3
Treatment administration
For those receiving CC-486, the medication is administered orally in tablet form. The dosage includes either 150 mg or 200 mg tablets, taken as prescribed by the study protocol.
Pembrolizumab is administered intravenously, meaning it is given through a vein, according to the schedule set by the study.
Step 4
Monitoring and assessments
Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.
Assessments include imaging tests to measure disease progression and laboratory tests to monitor health status.
Step 5
Completion of treatment
The treatment phase continues until the study's end date or until specific criteria for stopping treatment are met.
Participants are evaluated for overall survival and response to treatment, including any adverse effects experienced during the trial.

Who can join the trial?

7 criteria

The person must be at least 18 years old when they sign the consent form.
The person must have a confirmed diagnosis of a type of lung cancer called **non-small cell lung cancer (NSCLC)**, which can be either squamous or non-squamous.
The person must have **stage IIIB or IV NSCLC**, meaning the cancer is advanced or has spread to other parts of the body, and they must have already received one type of chemotherapy that includes a drug called platinum.
The person must provide a sample of their tumor tissue, which is preserved in a special way called **formalin-fixed**, from a biopsy done after the cancer was found to have spread. This sample should be from a part of the body that hasn't been treated with radiation, to check for a protein called **PD-L1**.
The person must have a disease that can be measured using scans or other tests, according to specific guidelines called **RECIST 1.1**.
The person must have a **performance status** of 0 to 1 on a scale called **ECOG**, which means they are fully active or have some symptoms but can still do light work.
The person must have organs and bone marrow that are working well enough to participate in the study.

Who cannot join the trial?

7 criteria

Patients who have a different type of cancer than the one being studied.
Patients who have already received more than one type of treatment for their lung cancer.
Patients with serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures.
Patients who have had an allergic reaction to similar medications in the past.
Patients who are participating in another clinical trial at the same time.

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Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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Catania, Italy

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Investigated drugs

CC-486
is an oral form of azacitidine. It is being studied to see if it can help treat non-small cell lung cancer when used in combination with another medication. Azacitidine is known to affect the growth of cancer cells and may help slow down or stop their growth.
Pembrolizumab
, also known by its code name MK-3475, is an immunotherapy drug. It works by helping the immune system recognize and attack cancer cells. It is used in this study to see if it can improve outcomes for patients with non-small cell lung cancer when combined with other treatments.

What is already known about the treatment

CC-486 (oral azacitidine)
This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC) that is locally advanced or has metastasized. It is used as a second-line treatment option. CC-486 works by inhibiting DNA methylation, which can reactivate tumor suppressor genes and lead to cancer cell death. It is classified as a hypomethylating agent.
Pembrolizumab (MK-3475)
This medication is administered via intravenous infusion and is widely used in the treatment of various cancers, including non-small cell lung cancer (NSCLC). It is an immune checkpoint inhibitor that works by blocking the PD-1 pathway, thereby enhancing the immune system's ability to detect and destroy cancer cells. Pembrolizumab is classified as a monoclonal antibody.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is known for its slower progression compared to small cell lung cancer. It often spreads to other parts of the body, including the bones, brain, and liver. Symptoms may include a persistent cough, chest pain, and difficulty breathing. The disease is typically diagnosed at an advanced stage, which can complicate management and treatment.