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Study on Pembrolizumab and Olaparib for Patients with Extensive-Stage Small-Cell Lung Cancer

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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 Extensive-Stage Small-Cell Lung Cancer (ES-SCLC). The study will explore the effectiveness of a treatment approach that combines chemotherapy and immunotherapy, followed by maintenance therapy using two medications: pembrolizumab and olaparib. Pembrolizumab is a type of immunotherapy that helps the immune system fight cancer, while olaparib is a medication that targets cancer cells with specific genetic features.

The purpose of the study is to evaluate how well this treatment approach works in preventing the cancer from getting worse. Participants will initially receive a combination of chemotherapy and immunotherapy. After this initial phase, they will continue with maintenance therapy using pembrolizumab and olaparib. The study will also include a comparison with a placebo to better understand the effectiveness of the treatment.

Throughout the study, participants will receive regular check-ups and monitoring to assess their health and the progress of the treatment. The study aims to provide valuable information on the potential benefits of this treatment approach for patients with ES-SCLC. The trial is expected to continue until 2026, with the goal of improving outcomes for individuals affected by this type of lung cancer.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The initial treatment phase involves the administration of a combination of medications to treat extensive-stage small-cell lung cancer.

    The medications include pembrolizumab administered through an intravenous infusion, cisplatin or carboplatin also given by infusion, and etoposide provided as an infusion.

    This phase is designed to introduce chemo-immunotherapy as the first line of treatment.

  2. Step 2

    Maintenance phase

    Following the initial treatment, the maintenance phase begins.

    During this phase, pembrolizumab continues to be administered through intravenous infusion.

    Additionally, olaparib is introduced as a film-coated tablet taken orally.

    The purpose of this phase is to maintain the treatment effects achieved during the initial phase.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

    Progression-free survival, which refers to the length of time during and after treatment that the cancer does not worsen, is a key measure during this period.

    Additional assessments include objective response rates and overall survival rates.

Who can join the trial?

18 criteria

  • The participant or their legal representative must provide written consent to join the trial.
  • The participant should have a life expectancy of at least 12 weeks.
  • The participant must be able to swallow.
  • The participant should be able to follow the study plan, as judged by the study doctor.
  • The participant must have proper organ function, as defined by specific tests done within 10 days before joining the study.
  • The participant must have a negative test for the human immunodeficiency virus (HIV) at the start of the study.
  • The participant must have a negative test for hepatitis B, or if the first test is positive, a follow-up test must be negative for the hepatitis B virus.
  • The participant must have a negative test for hepatitis C, or if the first test is positive, a follow-up test must be negative for the hepatitis C virus.
  • Male participants must use a condom during treatment and for 3 months after the last dose of the study drug when having sexual intercourse with a pregnant woman or a woman who can become pregnant. Female partners should also use a highly effective form of birth control.
  • Female participants must not be pregnant or breastfeeding and must agree to use birth control during the study and for at least 120 days after the last dose of the study drug if they can become pregnant.
  • Participants must be at least 18 years old on the day they sign the consent form.
  • Participants must have a confirmed diagnosis of small-cell lung cancer (SCLC) at an extensive stage, which is a specific stage of cancer spread.
  • A tissue sample from the tumor must be available, either from a recent biopsy or an older one if no treatment has occurred since the biopsy and it was done within 6 weeks before joining the study.
  • Participants must not have had any previous systemic treatment for extensive-stage small-cell lung cancer. If they had treatment for a limited stage, it must have been with the intent to cure, and there must be a gap of at least 6 months since the last treatment.
  • Participants who need radiation therapy to the chest can join if the therapy starts at least 15 days after the experimental treatment begins. Those who had more than 30 Gy of radiation to the lungs within 6 months before the study will be excluded.
  • Participants must have measurable cancer lesions, which are areas of cancer that can be measured, even if they were previously treated with radiation, as long as they have shown growth.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which is a scale used to assess how well a patient can perform daily activities. This assessment must be done within 7 days before joining the study.
  • Participants with paraneoplastic syndromes, which are conditions related to cancer, can join if an autoimmune cause is ruled out, based on local medical practices.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer other than Extensive-Stage Small-Cell Lung Cancer (ES SCLC) cannot participate. This type of cancer is a specific form of lung cancer that has spread widely in the body.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.
  • Patients who have any medical condition or are taking any medication that might interfere with the study treatment cannot participate. This is to ensure the safety and accuracy of the study results.
  • Patients who have previously received treatment that is similar to the study treatment may not be eligible. This is to ensure that the study results are not affected by previous treatments.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate. This is important for the consistency and reliability of the study.
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Investigated drugs

  • Pembrolizumab

    is a type of immunotherapy that helps the body's immune system fight cancer cells. It works by blocking a specific protein on the surface of cancer cells, allowing the immune system to recognize and attack them more effectively.

  • Olaparib

    is a medication that targets cancer cells by interfering with their ability to repair DNA. This can lead to the death of cancer cells, especially those that are already damaged or rapidly dividing, such as in certain types of lung cancer.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating extensive-stage small-cell lung cancer (ES-SCLC). It is an immunotherapy drug that works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. Pembrolizumab is classified as a monoclonal antibody and is used primarily for its immune checkpoint inhibition properties.

  • Olaparib

    Olaparib is taken orally and is under investigation in clinical trials for its role in treating extensive-stage small-cell lung cancer (ES-SCLC). It is a targeted therapy known as a PARP inhibitor, which works by interfering with the cancer cells' ability to repair their DNA, leading to cell death. Olaparib is classified as an antineoplastic agent and is used to exploit the weaknesses in cancer cell DNA repair mechanisms.

Investigated diseases

Extensive-Stage Small-Cell Lung Cancer – This is a type of lung cancer characterized by the rapid growth of small cells in the lung tissue. It is called "extensive-stage" when the cancer has spread beyond the lung to other parts of the body. The disease typically progresses quickly, with cancer cells multiplying and spreading to distant organs. Symptoms may include coughing, chest pain, and difficulty breathing, often appearing suddenly and worsening rapidly. As the disease advances, it can lead to complications such as fluid buildup around the lungs and difficulty in oxygen exchange. The progression of this cancer is often aggressive, requiring prompt medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514666-39-00Protocol codeIRST162.14Estimated enrolment60 patientsSponsorIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

sourced from the EU Clinical Trials Register and site verification

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