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Testing MK-2870 with pembrolizumab compared to pembrolizumab alone after surgery in patients with non-small cell lung cancer who did not respond fully to treatment

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 studying non-small cell lung cancer that can be removed by surgery and is classified as Stage II, IIIA, or IIIB with lymph node involvement. The trial involves several treatment medications. The main treatments being tested are MK-2870, which is also known as sacituzumab tirumotecan, and pembrolizumab, which is marketed as Keytruda. Additional chemotherapy medications that may be used include paclitaxel, gemcitabine, pemetrexed, carboplatin, and cisplatin. Supportive medications such as paracetamol, codeine phosphate, antihistamines, and glucocorticoids may also be given to manage side effects. All of these medications are given through infusion into a vein or by other methods as needed.

The purpose of this study is to compare how well MK-2870 combined with pembrolizumab works compared to pembrolizumab alone in preventing the cancer from coming back after surgery. Before being assigned to one of these treatment groups, participants will first receive pembrolizumab along with platinum-based chemotherapy before surgery, which is called neoadjuvant treatment. After surgery, if cancer cells are still found in the removed tissue, meaning a complete response was not achieved, participants will then be randomly assigned to receive either MK-2870 plus pembrolizumab or pembrolizumab alone as adjuvant treatment, which means treatment given after surgery to reduce the risk of cancer returning.

During the study, participants will have regular check-ups that include imaging scans such as computed tomography or magnetic resonance imaging to monitor for any signs of cancer returning. The study will measure how long participants remain free of disease, how long they survive overall, and whether the cancer spreads to distant parts of the body. Researchers will also assess quality of life and monitor for any side effects throughout the treatment period. The treatment period can last up to several months, and participants will continue to be followed for a number of years to track long-term outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Neoadjuvant treatment period

    This phase occurs before surgery. Treatment will be administered through intravenous infusion, which means medication will be delivered directly into a vein.

    The treatment consists of pembrolizumab combined with platinum-based doublet chemotherapy. Platinum-based chemotherapy may include medications such as carboplatin or cisplatin, combined with another chemotherapy drug such as gemcitabine, paclitaxel, or pemetrexed.

    Supportive medications may be provided to manage side effects, including paracetamol for pain relief and h2-receptor antagonists to protect the stomach.

  2. Step 2

    Surgery

    After completing the neoadjuvant treatment, surgical removal of the lung cancer will be performed.

    The surgeon will remove the tumor and surrounding tissue. Tissue samples from the surgery will be sent to a laboratory to determine if all cancer cells have been eliminated and to test for specific markers called PD-L1 and TROP2.

    If the pathology results show that not all cancer cells were eliminated (meaning pathological complete response was not achieved), eligibility for the next phase of the trial will be confirmed.

  3. Step 3

    Recovery and re-assessment

    After surgery, a period of recovery will occur before starting the next treatment phase.

    Within 28 days before starting adjuvant treatment, imaging scans will be performed. These will include a CT scan (computed tomography) or MRI (magnetic resonance imaging) of the chest, abdomen, and pelvis with contrast. These scans will confirm that no disease is detectable after surgery.

    Any side effects from previous treatments must have improved to a mild level or returned to baseline before proceeding, except for certain hormone-related side effects that are being managed with hormone replacement therapy.

  4. Step 4

    Randomization to adjuvant treatment

    Once eligibility is confirmed, assignment to one of two treatment groups will occur through a process called randomization, which is similar to a coin flip.

    One group will receive pembrolizumab alone, administered through intravenous infusion.

    The other group will receive pembrolizumab combined with MK-2870 (also known as sacituzumab tirumotecan), both administered through intravenous infusion.

    This is an open-label trial, meaning both the treating physician and the patient will know which treatment is being received.

  5. Step 5

    Adjuvant treatment period

    The assigned treatment will be administered through intravenous infusion on a regular schedule. Specific dosage, frequency, and duration will be determined according to the trial protocol.

    Supportive medications may continue to be provided to manage potential side effects.

    Regular monitoring will occur throughout this period to assess how the treatment is being tolerated and to check for any side effects.

  6. Step 6

    Follow-up and monitoring

    Regular assessments will be conducted to monitor for any signs of cancer returning. The primary measure being evaluated is disease-free survival, which means the length of time remaining free of cancer after treatment.

    These assessments will be performed by both the treating physician and by independent reviewers who do not know which treatment was received (called blinded independent central review).

    Additional monitoring will include assessments of overall survival, whether cancer has spread to distant parts of the body, and lung cancer-specific survival.

    Quality of life will be evaluated through questionnaires that ask about physical functioning, ability to perform daily activities, breathing difficulties, coughing, and chest pain.

    Any adverse events or side effects will be recorded, and any changes to treatment due to side effects will be documented.

    The trial is expected to continue until October 2034, though individual participation duration may vary.

Who can join the trial?

11 criteria

  • You must have a confirmed diagnosis of non-small cell lung cancer (a type of lung cancer) that can be removed by surgery, at stage II, IIIA, or IIIB with cancer spread to nearby lymph nodes (small bean-shaped organs that are part of the immune system).
  • If you test positive for hepatitis B surface antigen (a marker showing hepatitis B infection), you can participate if you have been taking hepatitis B antiviral medication for at least 4 weeks and the virus is not detectable in your blood at the screening visit.
  • If you have had hepatitis C virus infection in the past, you can participate if the virus is not detectable in your blood for at least 4 weeks before starting the study treatment.
  • Your doctor must confirm that you do not need specific treatments targeting EGFR or ALK (certain proteins that can drive cancer growth) as your main treatment.
  • Your doctor and surgeon must agree that you are able to have surgery.
  • You must be able to receive pembrolizumab (a type of immunotherapy) and chemotherapy with platinum-based drugs before surgery.
  • For the part of the study after surgery: Your cancer must not have completely disappeared after the pre-surgery treatment, as confirmed by examination of tissue removed during surgery.
  • For the part of the study after surgery: A sample of the tumor tissue removed during surgery must be provided to check for PD-L1 and TROP2 (proteins on cancer cells) before being assigned to a treatment group.
  • For the part of the study after surgery: Scans (CT or MRI) done within 28 days before treatment assignment must show that you are disease-free.
  • If you had side effects from previous cancer treatments, these must have improved to mild or returned to your baseline level. If you have hormone-related side effects that are well controlled with hormone replacement therapy, you can participate.
  • If you have HIV infection (a virus that affects the immune system), your condition must be well controlled with antiretroviral therapy (medication that controls HIV).

Who cannot join the trial?

3 criteria

  • The study information provided does not contain specific exclusion criteria, which are reasons why a patient cannot participate in the clinical trial
  • Without detailed exclusion criteria listed in the source data, it is not possible to provide specific conditions that would prevent participation in this study
  • Typically, exclusion criteria may include things like other serious medical conditions, previous treatments, or certain test results, but these specific details are not available in the provided information
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Investigated drugs

  • Pembrolizumab

    is a type of cancer treatment that helps your immune system fight cancer cells. It works by blocking a protein that prevents your immune system from attacking the cancer, allowing your body's natural defenses to better recognize and destroy cancer cells in your lungs.

  • MK-2870

    is an investigational medication being studied in combination with pembrolizumab. It is designed to work together with pembrolizumab to enhance the immune system's ability to fight cancer cells that remain after surgery for lung cancer.

  • Platinum-based doublet chemotherapy

    is a combination of two chemotherapy drugs, one of which contains platinum. These medications work by killing fast-growing cancer cells or stopping them from dividing and growing. This type of chemotherapy is given before surgery to help shrink the tumor.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is a type of cancer immunotherapy medication given through an intravenous infusion directly into a vein, typically administered in a hospital or clinic setting. It is an established and widely approved treatment in modern cancer care, particularly for lung cancer and other types of tumors. This medication works by blocking a protein called PD-1 on immune cells, which allows the body's own immune system to recognize and attack cancer cells more effectively. Pembrolizumab belongs to a class of drugs known as immune checkpoint inhibitors or monoclonal antibodies.

  • MK-2870

    MK-2870 is an investigational cancer treatment currently being studied in clinical trials and is not yet approved for routine medical use. It is being evaluated as an additional therapy combined with pembrolizumab for patients with non-small cell lung cancer who have undergone surgery. While the exact mechanism of action is still under investigation, it is designed to work alongside immunotherapy to enhance the body's ability to fight cancer cells. This medication represents a potential new option in the pharmacological treatment of lung cancer, though its safety and effectiveness are still being determined through ongoing research.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of lung cancer that begins in the tissues of the lungs. It is the most common form of lung cancer, accounting for about 85% of all lung cancer cases. The disease develops when cells in the lungs grow abnormally and form tumors. In the early stages, it may not cause noticeable symptoms, but as it progresses, patients may experience coughing, chest pain, and difficulty breathing. The cancer can spread to nearby lymph nodes and other parts of the body if not addressed. Clinical stages II, IIIA, and IIIB indicate different levels of tumor size and spread to surrounding tissues and lymph nodes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508012-35-00Protocol codeMK-2870-019Estimated enrolment794 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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