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Study of Pembrolizumab, Olaparib, and Pemetrexed for Patients with Stage IV Non-Small Cell Lung Cancer

Verified siteRegistered 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 treatments for metastatic non-squamous non-small-cell lung cancer (NSCLC), which is a type of advanced lung cancer. The study involves several medications, including Pembrolizumab, Pemetrexed, Carboplatin, Cisplatin, and Olaparib. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer. Olaparib, with the code name MK-7339, is a medication that targets cancer cells directly. Pemetrexed, Carboplatin, and Cisplatin are chemotherapy drugs that help stop the growth of cancer cells.

The purpose of this study is to compare the effectiveness of different treatment combinations in improving the survival of patients with this type of lung cancer. Participants will receive a combination of Pembrolizumab with either Pemetrexed and a platinum-based drug (Carboplatin or Cisplatin) or Olaparib. After the initial treatment phase, participants will continue with either Olaparib or Pemetrexed as maintenance therapy. Some participants may receive a placebo during the maintenance phase to help researchers understand the effects of the medications better.

The study will take place over several months, with regular check-ups and assessments to monitor the participants' health and the cancer's response to the treatment. The goal is to determine which combination of treatments offers the best outcomes in terms of slowing down the progression of the cancer and improving overall survival. Participants will be closely monitored for any side effects or changes in their condition throughout the study.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Induction phase

    The induction phase involves the administration of pembrolizumab in combination with either carboplatin or cisplatin and pemetrexed. These medications are given through an intravenous infusion.

    The purpose of this phase is to initiate treatment for metastatic non-squamous non-small-cell lung cancer (NSCLC).

  2. Step 2

    Maintenance phase

    Following the induction phase, the maintenance phase begins. This phase involves continued treatment with pembrolizumab and either olaparib or pemetrexed.

    Olaparib is administered orally in the form of film-coated tablets. The specific dosage and frequency will be determined by the healthcare provider.

    The goal of the maintenance phase is to sustain the treatment's effectiveness and manage the disease.

  3. Step 3

    Evaluation of treatment response

    Throughout the trial, the response to treatment is evaluated using criteria known as Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

    This evaluation helps in assessing the progression-free survival (PFS) and overall survival (OS) of participants.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for any adverse events or side effects that may occur during the trial.

    Regular follow-up appointments are scheduled to ensure the safety and well-being of participants and to adjust treatment as necessary.

Who can join the trial?

11 criteria

  • The patient must have a confirmed diagnosis of a type of lung cancer called nonsquamous NSCLC (Non-Small Cell Lung Cancer).
  • The patient must have stage IV nonsquamous NSCLC, which means the cancer has spread to other parts of the body.
  • The patient must not need specific treatments aimed at certain genetic changes in the cancer, like EGFR, ALK, or ROS1.
  • The patient must have cancer that can be measured using specific criteria called RECIST 1.1.
  • The patient must provide a sample of their tumor tissue, either from a previous sample or a new biopsy, to be checked by a central lab.
  • The patient must have a life expectancy of at least 3 months.
  • The patient must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient must not have received previous treatments that affect the whole body for their advanced or metastatic NSCLC.
  • The patient must have organs that are working well enough to handle the treatment.
  • Male and female patients who can have children must use birth control during the treatment and for 180 days after.
  • Male patients must not donate sperm, and female patients must not donate eggs or store them for future use during the treatment and for 180 days after.

Who cannot join the trial?

4 criteria

  • Patients who do not have Stage IV lung cancer cannot participate. Stage IV means the cancer has spread to other parts of the body.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.
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Investigated drugs

  • Pembrolizumab

    is a medication used in cancer treatment. It works by helping the immune system recognize and attack cancer cells. In this trial, it is used in combination with other medications to treat metastatic non-squamous non-small-cell lung cancer.

  • Pemetrexed

    is a chemotherapy drug that interferes with the growth of cancer cells. It is used in this trial as part of the initial treatment and as a maintenance therapy to help prevent the cancer from returning.

  • Platinum (Carboplatin or Cisplatin)

    refers to a group of chemotherapy drugs that contain platinum. These drugs work by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, either carboplatin or cisplatin is used in combination with other medications to treat lung cancer.

  • Olaparib

    is a medication that targets cancer cells with specific genetic mutations. It works by blocking an enzyme that cancer cells need to repair their DNA, leading to cell death. In this trial, olaparib is used as a maintenance therapy to help keep the cancer from coming back after initial treatment.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently used in clinical trials for treating advanced lung cancer. It is widely recognized in medical literature as an immune checkpoint inhibitor. Pembrolizumab is primarily indicated for various types of cancer, including non-small-cell lung cancer. It works by blocking the PD-1 pathway, which helps the immune system detect and fight cancer cells more effectively. It belongs to the pharmacological class of monoclonal antibodies.

  • Pemetrexed

    Administered intravenously, this medication is used in combination with other drugs for treating lung cancer. It is well-documented in medical literature as an antifolate chemotherapy agent. Pemetrexed is mainly indicated for non-squamous non-small-cell lung cancer. It works by disrupting folate-dependent metabolic processes essential for cell replication. It is classified as an antimetabolite.

  • Olaparib

    Taken orally, this medication is currently being studied for its effectiveness in maintaining treatment for lung cancer. It is recognized in medical literature as a PARP inhibitor. Olaparib is primarily indicated for cancers with specific genetic mutations, such as BRCA mutations. It works by inhibiting the PARP enzyme, leading to DNA damage in cancer cells and ultimately causing their death. It belongs to the class of targeted cancer therapies.

  • Carboplatin

    This medication is administered intravenously and is used in combination with other drugs for treating lung cancer. It is well-established in medical literature as a platinum-based chemotherapy agent. Carboplatin is mainly indicated for various types of cancer, including lung cancer. It works by binding to DNA and interfering with the cell's repair mechanism, leading to cell death. It is classified as an alkylating agent.

  • Cisplatin

    Administered intravenously, this medication is used in combination with other drugs for treating lung cancer. It is widely recognized in medical literature as a platinum-based chemotherapy agent. Cisplatin is primarily indicated for various types of cancer, including lung cancer. It works by forming cross-links in DNA, which prevents cell division and leads to cell death. It belongs to the class of alkylating agents.

Investigated diseases

Stage IV Lung Cancer – This is an advanced form of lung cancer where the disease has spread beyond the lungs to other parts of the body. It typically involves metastasis to areas such as the brain, bones, liver, or adrenal glands. Symptoms may include persistent cough, chest pain, shortness of breath, and weight loss. As the disease progresses, it can lead to more severe respiratory issues and systemic symptoms. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower course. The focus in managing this stage often involves controlling symptoms and maintaining quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509774-40-00Protocol codeMK-7339-006Estimated enrolment672 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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