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Study of Pembrolizumab, Carboplatin, and Paclitaxel for Patients with Metastatic Squamous Non-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 the treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC), a type of lung cancer that has spread to other parts of the body. The study involves several medications, including Pembrolizumab, also known by its code name MK-3475, which is given as an infusion into the vein. Another medication used in the study is Olaparib, taken as a tablet by mouth. Additionally, the study includes Carboplatin and Paclitaxel, which are also given as infusions, and a version of Paclitaxel that is bound to a protein called albumin, known as Paclitaxel Albumin-Bound. A placebo is also used in the study.

The purpose of the study is to compare the effectiveness of Pembrolizumab combined with Olaparib against Pembrolizumab combined with a placebo in treating this type of lung cancer. The study aims to see how these treatments affect the time patients live without the cancer getting worse and their overall survival. Participants will receive the treatments over a period of time, and their health will be monitored to assess the effects of the medications.

Throughout the study, participants will receive regular check-ups and assessments to monitor their response to the treatment and any side effects they may experience. The study is designed to provide valuable information on the potential benefits and risks of using these medications in combination for treating Metastatic Squamous Non-small Cell 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

    Receive an intravenous infusion of pembrolizumab (KEYTRUDA 25 mg/mL) in combination with carboplatin and paclitaxel or paclitaxel albumin-bound. This phase involves regular hospital visits for the administration of these medications.

    The frequency and duration of this phase depend on the specific treatment plan and response to the medications.

  2. Step 2

    Maintenance phase

    Continue with pembrolizumab treatment. Additionally, receive either olaparib or a placebo orally. The choice between olaparib and placebo is determined by the study design.

    This phase aims to maintain the effects of the initial treatment and is expected to continue until disease progression or unacceptable side effects occur.

  3. Step 3

    Monitoring and follow-up

    Undergo regular assessments to monitor the response to treatment and any side effects. These assessments may include imaging tests and laboratory evaluations.

    The frequency of these assessments is determined by the study protocol and the healthcare provider's recommendations.

Who can join the trial?

10 criteria

  • Have a confirmed diagnosis of **squamous non-small cell lung cancer (NSCLC)**, which is a type of lung cancer.
  • Be in **Stage IV** of squamous NSCLC, meaning the cancer has spread to other parts of the body.
  • Have a **measurable disease** based on specific medical guidelines called RECIST 1.1, which helps doctors assess the size of tumors.
  • Have not received any previous treatment for their advanced or metastatic NSCLC.
  • Provide a sample of tumor tissue, either from a previous biopsy or a new one, that has not been treated with radiation. This sample must be approved by a central laboratory before starting the study.
  • Have a **performance status** of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Have a life expectancy of at least 3 months.
  • Have **adequate organ function**, meaning the organs are working well enough to handle the treatment.
  • Male participants must not donate sperm during the treatment and for 180 days after.
  • Male and female participants who can have children must use birth control during the treatment and for 180 days after.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not fully recovered from previous cancer treatments.
  • Patients with serious heart problems.
  • Patients with active infections that require treatment.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had another cancer in the past, unless it was treated and has not come back for a long time.
  • Patients who have a known allergy to the study drugs.
  • Patients who are taking other medications that might interfere with the study drugs.
  • Patients with certain medical conditions that might make it unsafe to participate.
  • Patients who have participated in another clinical trial recently.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this study to help the body's immune system fight cancer cells. It is often used in combination with other treatments to improve its effectiveness in treating certain types of cancer, such as metastatic squamous non-small cell lung cancer.

  • Carboplatin

    is a chemotherapy drug that works by stopping the growth of cancer cells. It is used in combination with other medications to treat various types of cancer, including lung cancer.

  • Paclitaxel

    is another chemotherapy medication that helps stop cancer cells from dividing and growing. It is used in combination with other drugs to treat different types of cancer, including lung cancer.

  • Nab-paclitaxel

    is a form of paclitaxel that is bound to a protein called albumin. This formulation helps deliver the medication more effectively to the cancer cells and is used in combination with other treatments for lung cancer.

  • Olaparib

    is a medication used as a maintenance therapy in this study. It works by blocking certain enzymes that cancer cells need to repair themselves, which can help slow down or stop the growth of cancer. It is used after initial treatment to help keep the cancer from coming back.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently used in clinical trials for treating metastatic squamous non-small cell lung cancer (NSCLC). It is a well-established immunotherapy drug in medical literature, primarily used to enhance the body's immune response against cancer cells. Pembrolizumab works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as a monoclonal antibody and is part of the immune checkpoint inhibitor class of drugs.

  • Olaparib

    This medication is taken orally and is being studied in combination with pembrolizumab for the treatment of metastatic squamous non-small cell lung cancer (NSCLC). It is recognized in medical literature as a maintenance therapy option in certain cancers. Olaparib functions by inhibiting the enzyme PARP, which is involved in DNA repair, leading to the accumulation of DNA damage in cancer cells and ultimately causing their death. It is classified as a PARP inhibitor and is used to exploit the weaknesses in cancer cells' DNA repair mechanisms.

Investigated diseases

Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the squamous cells, which are flat cells that line the inside of the airways in the lungs. It is classified as non-small cell lung cancer, which is the most common type of lung cancer. When it becomes metastatic, it means the cancer has spread from the lungs to other parts of the body. The progression of this disease involves the growth and spread of cancerous cells, which can invade nearby tissues and organs. As the disease advances, it can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. The progression can vary greatly among individuals, depending on various factors including the stage at diagnosis and overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508449-41-00Protocol codeMK-7339-008Estimated enrolment561 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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