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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 study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Catania Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not recruiting
23.12.2015

Trial locations

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.

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.

Trial ID:
2024-513405-31-00
Protocol code:
CC-486-NSCL-001
Trial Phase:
Therapeutic exploratory (Phase II)

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