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Study of Pembrolizumab and MK-2870 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 will explore the effectiveness of a combination of medications, including pembrolizumab, carboplatin, and taxane (either paclitaxel or nab-paclitaxel). Additionally, the trial will investigate the use of pembrolizumab with or without a maintenance treatment called MK-2870, also known as sacituzumab tirumotecan.

The purpose of the study is to compare the overall survival of patients receiving these treatments. Participants will receive the medications through an intravenous infusion, which means the drugs are delivered directly into the bloodstream through a vein. The study will be conducted over a period of time, with regular monitoring to assess the effects of the treatment. Participants will be closely observed for any side effects or changes in their condition.

This trial aims to provide valuable information on the potential benefits and risks of these treatments for patients with metastatic squamous NSCLC. By participating in the study, researchers hope to gain insights that could lead to improved treatment options for this type of lung cancer in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initiation of treatment

    Upon joining the study, the treatment begins with the administration of pembrolizumab in combination with either carboplatin and paclitaxel or nab-paclitaxel. These medications are given through an intravenous infusion.

    The initial phase involves receiving these medications as part of the first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC).

  2. Step 2

    Induction phase

    During the induction phase, the combination of pembrolizumab with carboplatin and taxane (either paclitaxel or nab-paclitaxel) is continued.

    This phase is designed to assess the initial response to the treatment and typically lasts for several weeks.

  3. Step 3

    Evaluation

    After the induction phase, an evaluation is conducted to determine the response to the treatment. This involves imaging studies to assess the size and spread of the cancer.

    The evaluation helps in deciding whether to continue with the current treatment plan or make adjustments.

  4. Step 4

    Maintenance phase

    If the cancer has not progressed, the treatment may continue with pembrolizumab alone or in combination with MK-2870 as a maintenance therapy.

    The maintenance phase aims to sustain the response achieved during the induction phase and is continued until disease progression or unacceptable side effects occur.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to track the effectiveness of the treatment and any side effects experienced.

    Follow-up visits include physical examinations, imaging studies, and laboratory tests to ensure the safety and well-being of the participant.

Who can join the trial?

10 criteria

  • Participants must have a confirmed diagnosis of **squamous non-small cell lung cancer (NSCLC)** at Stage IV, which is an advanced stage of lung cancer.
  • The disease must be measurable according to specific criteria used to evaluate tumors, known as **RECIST 1.1**.
  • If participants have had side effects from previous cancer treatments, these side effects must have improved to a mild level or returned to their usual state. If the side effects are related to hormones and are being treated with hormone replacement, participants can still join.
  • Participants with **HIV** must have their condition well controlled with medication.
  • Participants should have a life expectancy of at least 3 months.
  • Participants must have a performance status of 0 to 1, which means they are fully active or have some symptoms but can still carry out light work. This is assessed within 7 days before joining the study.
  • Participants with **hepatitis B** can join if they have been on antiviral therapy for at least 4 weeks and have no detectable virus in their blood.
  • Participants with a history of **hepatitis C** can join if they have no detectable virus in their blood at screening and have completed antiviral therapy at least 4 weeks before joining the study.
  • Participants must not have any progression of their lung cancer after completing the initial part of the study, as confirmed by an independent review using RECIST 1.1 criteria, with a scan done at Week 12 before starting the maintenance phase.
  • Both male and female participants are eligible to join the study.

Who cannot join the trial?

4 criteria

  • Participants who have already received treatment for their lung cancer cannot join the study. This means if you have had any therapy for your lung cancer before, you are not eligible.
  • Individuals with a different type of lung cancer than the one specified in the study are not eligible. The study is only for a specific type called **metastatic squamous Non-small Cell Lung Cancer (NSCLC)**.
  • People who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Participants who are part of a vulnerable population, which means groups that might need special protection, are not eligible for this study.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to help the 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 drug more effectively to cancer cells and is used in combination with other treatments for certain cancers.

  • MK-2870

    is an investigational drug being studied in this trial. It is used as a maintenance therapy to see if it can help improve outcomes for patients with metastatic squamous non-small cell lung cancer when used alongside pembrolizumab.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is used in the treatment of certain types of cancer, including metastatic squamous non-small cell lung cancer (NSCLC). It is currently well-established in medical literature as an effective immunotherapy. Pembrolizumab works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. It is classified as a monoclonal antibody and is part of the immune checkpoint inhibitor class of drugs.

  • Carboplatin

    Administered intravenously, carboplatin is a chemotherapy drug used to treat various cancers, including lung cancer. It is widely recognized in medical literature as a standard chemotherapy agent. Carboplatin works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It belongs to the class of drugs known as platinum-based antineoplastic agents.

  • Paclitaxel

    This medication is given intravenously and is used to treat several types of cancer, including lung cancer. It is well-documented in medical literature as a chemotherapy agent. Paclitaxel works by stabilizing the structure of microtubules in cells, which inhibits cell division. It is classified as a taxane, a type of antineoplastic agent.

  • Nab-paclitaxel

    Administered intravenously, nab-paclitaxel is a form of paclitaxel bound to albumin, used in cancer treatment, including lung cancer. It is recognized in medical literature for its enhanced delivery to tumors. Nab-paclitaxel works similarly to paclitaxel by disrupting microtubule function, thus inhibiting cell division. It is also classified as a taxane.

  • MK-2870

    This investigational drug is administered intravenously and is being studied for its potential use in cancer treatment. It is currently under investigation in clinical trials and not yet widely established in medical literature. The exact mechanism of action is still being studied, but it is believed to target specific pathways involved in cancer cell growth. It is classified as an experimental therapeutic agent.

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 is metastatic, it means the cancer has spread from the lungs to other parts of the body. The disease progresses as cancer cells grow uncontrollably and form tumors, which can invade nearby tissues and organs. As the cancer advances, it can cause symptoms such as persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, and it often requires ongoing monitoring and management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510128-66-00Protocol codeMK-2870-023Estimated enrolment892 patientsSponsorMerck Sharp & Dohme LLC

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).