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Study Comparing MK-2870 with Chemotherapy (Docetaxel or Pemetrexed) for Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutations

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 a type of lung cancer known as Non-small Cell Lung Cancer (NSCLC), specifically in patients who have certain genetic changes, such as EGFR mutations. The study is comparing a new treatment called MK-2870 with standard chemotherapy options, which include drugs like Docetaxel and Pemetrexed. These treatments are used for patients whose cancer has advanced or spread to other parts of the body after previous treatments.

The purpose of the study is to see how well MK-2870 works compared to the chemotherapy drugs in terms of slowing down the cancer and improving survival. Participants will receive either MK-2870 or one of the chemotherapy drugs, and some may receive a placebo. The study will involve regular check-ups and assessments to monitor the cancer's response to the treatment.

Throughout the study, participants will be closely monitored for any side effects or changes in their health. The study aims to provide valuable information on the effectiveness and safety of MK-2870 as a potential treatment option for patients with advanced NSCLC who have specific genetic changes. This research could lead to new insights and improvements in the treatment of this type of lung cancer.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments.

    Participants must have advanced or metastatic non-small cell lung cancer with specific genetic mutations.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the experimental drug MK-2870 or standard chemotherapy.

    The chemotherapy options include docetaxel or pemetrexed, administered through intravenous infusion.

  3. Step 3

    Treatment administration

    If assigned to the MK-2870 group, the drug is administered as a powder for solution for injection.

    For those receiving chemotherapy, docetaxel or pemetrexed is given through intravenous infusion according to the standard dosing schedule.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the progression of the disease and the participant's overall health.

    Assessments include imaging tests and evaluations based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

  5. Step 5

    Evaluation of outcomes

    The primary outcomes measured are progression-free survival and overall survival.

    Secondary outcomes include response rates, duration of response, and changes in quality of life scores.

  6. Step 6

    Completion of study

    The study is estimated to conclude by March 2030.

    Participants will be informed of the study results and any potential implications for their treatment.

Who can join the trial?

10 criteria

  • Have advanced or metastatic non-squamous **Non-small Cell Lung Cancer (NSCLC)** with specific mutations. This means the cancer is in a stage that cannot be removed by surgery or cured with radiation.
  • Have an **ECOG performance status** of 0 or 1. This is a scale that measures how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
  • Show proof of disease progression based on specific criteria called **RECIST 1.1** after the last treatment.
  • If you have certain genetic mutations, you must have received 1 or 2 prior treatments with a type of medication called **EGFR TKI**, and a specific third-generation TKI if you have a **T790M mutation**. You must also have had one treatment with platinum-based therapy after the disease progressed on or after EGFR TKI.
  • Be at least 18 years old at the time of giving consent to participate.
  • Have a measurable disease according to **RECIST 1.1** as determined by the local investigator.
  • Provide a sample of tumor tissue, either from a previous biopsy or a new one, from a tumor that has not been treated with radiation.
  • If you have side effects from previous cancer treatments, they must have improved to a mild level or returned to the level they were before treatment.
  • If you have **hepatitis B**, you must have been on antiviral therapy for at least 4 weeks and have an undetectable viral load before starting the trial.
  • If you are **HIV-positive**, your HIV must be well controlled with antiretroviral therapy (ART).

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer other than Non-small Cell Lung Cancer (NSCLC) cannot participate.
  • Patients without EGFR mutations in their cancer cells are not eligible. EGFR mutations are changes in a gene that can affect how cancer grows.
  • Patients who are not within the specified age range for the study cannot join. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, are not eligible.
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Investigated drugs

  • MK-2870

    is an investigational medication being studied for its effectiveness in treating advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with specific genetic changes, such as EGFR mutations. The trial aims to see how well this medication works compared to standard chemotherapy treatments.

  • Docetaxel

    is a type of chemotherapy used in this study as a comparison to MK-2870. It works by interfering with the growth of cancer cells, slowing or stopping their spread in the body.

  • Pemetrexed

    is another chemotherapy option used in the trial. It helps to block the growth of cancer cells by interfering with their ability to use folic acid, which is necessary for their growth and survival.

What is already known about the treatment

MK-2870 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for MK-2870 is NSCLC with EGFR mutations or other genomic alterations. At the molecular level, MK-2870 works by targeting and inhibiting specific pathways involved in cancer cell growth and survival. It is classified pharmacologically as a targeted therapy, aiming to interfere with cancer cell proliferation.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) – This is the most common type of lung cancer, accounting for about 85% of all cases. It typically starts in the epithelial cells lining the lungs and can grow and spread to other parts of the body. NSCLC is often categorized into subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, based on the type of cells affected. The disease progresses through stages, from localized tumors to more advanced stages where cancer has spread to lymph nodes or other organs. Symptoms may include a persistent cough, chest pain, and difficulty breathing, but they often appear only after the disease has advanced. The progression and symptoms can vary significantly depending on the specific genetic mutations present, such as those affecting the epidermal growth factor receptor (EGFR).
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503539-16-00Protocol codeMK2870-004Estimated enrolment562 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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