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Study of Pembrolizumab and Olaparib with Chemoradiation for Patients with Stage III 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 treatments for Stage III Non-Small Cell Lung Cancer (NSCLC), a type of lung cancer that is locally advanced and cannot be removed by surgery. The study involves several medications, including Pembrolizumab (also known by its code name MK-3475), Olaparib, Durvalumab, Paclitaxel, Carboplatin, Etoposide, Pemetrexed, and Cisplatin. Some participants will receive a combination of these drugs along with a placebo, which is a substance with no active medication.

The purpose of the study is to compare the effectiveness of different treatment combinations in managing NSCLC. Participants will receive treatments through intravenous infusions or oral tablets, depending on the medication. The study will follow a specific course where participants will first receive a combination of Pembrolizumab with concurrent chemoradiation therapy, followed by either continued Pembrolizumab with or without Olaparib, or a switch to Durvalumab. The study aims to observe how these treatments affect the progression of the disease and overall survival of the participants.

Throughout the study, participants will be monitored for any side effects and changes in their health status. The trial will also assess the impact of the treatments on the quality of life, including symptoms like cough, chest pain, and breathing difficulties. The study is expected to continue until 2026, providing valuable insights into the management of Stage III NSCLC.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be informed about the trial's purpose and procedures. Written consent is required to confirm understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes reviewing medical history, performing pulmonary function tests, and ensuring adequate organ function.

  3. Step 3

    Treatment phase 1: concurrent chemoradiation therapy

    Participants will receive pembrolizumab through intravenous infusion. This is combined with chemoradiation therapy, which involves the use of chemotherapy and radiation to treat cancer.

  4. Step 4

    Treatment phase 2: pembrolizumab with or without olaparib

    Following the initial treatment, participants will continue with pembrolizumab infusions. Some participants may also receive olaparib, which is taken orally. The decision to include olaparib is based on specific study criteria.

  5. Step 5

    Alternative treatment phase: durvalumab

    As an alternative to the pembrolizumab and olaparib combination, some participants will receive durvalumab through intravenous infusion after the initial chemoradiation therapy.

  6. Step 6

    Monitoring and follow-up

    Throughout the study, participants will undergo regular monitoring to assess the treatment's effectiveness and any side effects. This includes imaging tests and health assessments.

  7. Step 7

    Completion of the study

    Upon completion of the treatment phases, participants will have a final assessment to evaluate overall health and treatment outcomes. Long-term follow-up may be required to monitor health status.

Who can join the trial?

16 criteria

  • The patient must have a confirmed diagnosis of non-small cell lung cancer (NSCLC). This means the type of lung cancer has been identified through specific tests.
  • Male patients must agree to use birth control and not donate sperm during the study and for a certain time after the last treatment dose, unless they are unable to produce sperm due to medical reasons.
  • Female patients must not be pregnant or breastfeeding. They must agree to use birth control, not donate eggs, and not breastfeed during the study and for a certain time after the last treatment dose.
  • Female patients must have a negative pregnancy test before starting the study treatment.
  • The patient's medical and menstrual history, as well as recent sexual activity, will be reviewed to ensure there is no early undetected pregnancy.
  • The patient must have adequate lung function, meaning their lungs are working well enough to participate in the study.
  • The patient must have adequate organ function, meaning their organs are healthy enough to participate in the study.
  • The patient must provide written consent, agreeing to participate in the study.
  • The patient must have Stage IIIA, IIIB, or IIIC NSCLC, which refers to specific stages of lung cancer.
  • The patient must be unable to have surgery to completely remove the cancer for Stage III NSCLC.
  • The patient must not have evidence of cancer spreading to other parts of the body, which would indicate Stage IV NSCLC.
  • The patient must have measurable disease, meaning the cancer can be measured using specific criteria.
  • The patient must not have received previous treatment for Stage III NSCLC, such as chemotherapy or radiotherapy. Patients who had treatment for early-stage disease are not eligible.
  • The patient must provide a sample of their tumor tissue for analysis.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which indicates they are fully active or have some symptoms but can carry out light work.
  • The patient must have a life expectancy of at least 6 months.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than non-small cell lung cancer cannot participate. This type of cancer affects the lungs.
  • 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 not able to follow the study procedures or take the required medications cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate, as the study may affect the baby.
  • Patients who have participated in another clinical trial recently may not be eligible to participate.
  • Patients who have allergies or reactions to the study medications cannot participate.
  • Patients who are unable to provide informed consent, which means they cannot understand and agree to the study details, cannot participate.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this study to help the immune system fight cancer. It is given to participants in combination with other treatments to see if it can improve outcomes for those with a specific type of lung cancer that cannot be removed by surgery.

  • Olaparib

    is a medication that may help stop cancer cells from repairing themselves, which could make them more vulnerable to treatment. In this study, it is used alongside pembrolizumab to see if the combination is more effective than other treatments.

  • Durvalumab

    is another medication that helps the immune system attack cancer cells. It is used in this study as a comparison to see if it is more or less effective than the combination of pembrolizumab and olaparib in treating lung cancer.

  • Concurrent Chemoradiation Therapy

    is a standard treatment for certain types of cancer, including lung cancer. It involves giving chemotherapy and radiation therapy at the same time to try to shrink the tumor and stop the cancer from spreading. This therapy is used in combination with the medications being tested in the study.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently being studied in combination with chemoradiation therapy for treating non-small cell lung cancer. It is an established treatment in medical literature, known for its role in cancer immunotherapy. Pembrolizumab works by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. It is classified as a monoclonal antibody and is primarily used for various types of cancer, including lung cancer.

  • Olaparib

    Administered orally, this medication is being evaluated in combination with pembrolizumab and chemoradiation therapy for non-small cell lung cancer. It is recognized in medical literature for its use in cancer treatment, particularly in ovarian and breast cancers. Olaparib functions by inhibiting the enzyme PARP, which helps repair DNA damage in cells, thereby preventing cancer cell repair and promoting cell death. It is classified as a PARP inhibitor.

  • Durvalumab

    This medication is given intravenously and is part of ongoing research in combination with chemoradiation therapy for non-small cell lung cancer. It is well-documented in medical literature as an immunotherapy agent. Durvalumab works by targeting the PD-L1 protein on cancer cells, allowing the immune system to better detect and attack these cells. It is classified as a monoclonal antibody and is used in the treatment of certain cancers, including lung cancer.

Investigated diseases

Non-small cell lung cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. It often grows and spreads more slowly than small cell lung cancer. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503591-25-00Protocol codeMK-7339-012Estimated enrolment891 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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