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Study of ifinatamab deruxtecan, raludotatug deruxtecan and docetaxel in previously treated stage IV non-small cell lung cancer patients

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 study focuses on patients with Stage IV Non-small Cell Lung Cancer (NSCLC) who have already received previous treatments. The study evaluates three different medications: Ifinatamab Deruxtecan (also known as MK-2400), Raludotatug Deruxtecan (also known as MK-5909), and Docetaxel. These medications are given through intravenous infusion, which means they are administered directly into a vein.

The purpose of this research is to evaluate how well these treatments work in treating advanced non-squamous non-small cell lung cancer and to assess their safety. The study specifically includes patients whose cancer has progressed after receiving both platinum-based chemotherapy and immunotherapy treatments. The treatment period may last up to 24 months, during which patients will receive regular doses of one of the study medications.

Throughout the study, participants will undergo regular medical evaluations to monitor their response to treatment and any side effects. The research team will track various aspects of the participants' health, including how the tumor responds to treatment, how long the response lasts, and how long patients survive without their disease getting worse. The study will use specialized imaging to measure changes in tumor size and assess the effectiveness of the treatment.

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

    Initial assessment

    Your eligibility for the study will be confirmed through medical tests and examinations

    A tumor tissue sample will be collected through a new biopsy

    Your organ function and overall health status will be evaluated

    A pregnancy test will be performed if applicable

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive one of the following medications through intravenous infusion:

    - Ifinatamab deruxtecan

    - Docetaxel

    - Raludotatug deruxtecan

  3. Step 3

    Treatment period

    You will receive the assigned medication through intravenous infusion

    Your response to treatment will be monitored using imaging scans

    Regular assessments will track your health status and any side effects

    Your tumor response will be evaluated using RECIST criteria (standardized measurement of tumor changes)

  4. Step 4

    Ongoing monitoring

    Regular medical examinations will be performed to assess your health status

    Imaging scans will be conducted to monitor your disease progression

    Side effects will be tracked and documented throughout the study

    Treatment will continue as long as you are benefiting from it and no serious side effects occur

  5. Step 5

    Study completion

    The study will continue until 2032

    Your participation may end earlier if your disease progresses or you experience unacceptable side effects

    A final assessment will be performed when your participation ends

Who can join the trial?

15 criteria

  • Must be at least 18 years old and able to provide informed consent
  • Must have confirmed advanced non-squamous non-small cell lung cancer (Stage IV)
  • Must have measurable disease that can be evaluated using specific imaging criteria
  • Must have previously received two types of treatment: platinum-based chemotherapy and immunotherapy (anti-PD-(L)1 therapy), with disease progression after these treatments
  • Must have confirmation that targeted therapies for specific genetic mutations (EGFR, ALK, ROS1) are not needed
  • Must have a good level of physical function (ECOG score 0-1, meaning able to perform daily activities)
  • Must have adequate organ function
  • Must have a life expectancy of at least 3 months
  • Must provide a tissue sample from a tumor that has not been previously treated with radiation
  • Must provide a new tumor tissue sample from a fresh biopsy
  • If able to become pregnant, must not be pregnant or breastfeeding and must use effective contraception
  • If able to produce sperm, must use appropriate contraception and avoid sperm donation
  • If HIV-positive, must have well-controlled disease on anti-HIV medication
  • If hepatitis B positive, must have been on antiviral treatment for at least 4 weeks with undetectable virus levels
  • If history of hepatitis C, must have undetectable virus levels during screening

Who cannot join the trial?

12 criteria

  • Prior treatment with any anti-cancer therapy (chemotherapy, targeted therapy, or immunotherapy) within 14 days before starting the study
  • History of severe allergic reactions to medications or biological products
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Active autoimmune disease (condition where the immune system attacks healthy cells) requiring systemic treatment
  • Uncontrolled heart conditions including:
    • High blood pressure
    • Irregular heartbeat
    • Heart failure
    • Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
    • Other active cancers requiring treatment (except for adequately treated non-melanoma skin cancer or cervical cancer)
    • Pregnant or breastfeeding women
    • Significant liver or kidney problems
    • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

I apologize, but I don't see any specific medications or therapies listed in the provided trial data. The data only shows that this is a Phase 2 umbrella study for treating Stage IV nonsquamous non-small cell lung cancer (NSCLC), but the actual investigational agents are not specified in the source data. Without information about the specific medications or therapies being studied, I cannot provide descriptions of them. If you would like me to describe medications for this trial, please provide additional data that includes the specific investigational agents or therapies being studied.

What is already known about the treatment

Since no specific medication names are provided in the trial data, I can describe the typical medications used in Non-small Cell Lung Cancer (NSCLC) clinical trials: Pembrolizumab - An immunotherapy medication administered through intravenous infusion that works by helping the immune system detect and fight cancer cells. It belongs to the class of PD-1 inhibitors and is commonly used in advanced non-small cell lung cancer treatment, particularly when tumors express PD-L1. The medication works by blocking the PD-1 pathway, which normally prevents T cells from attacking cancer cells. Pemetrexed - A chemotherapy drug given through intravenous infusion that interferes with the growth of cancer cells by blocking several enzymes needed for cell reproduction. It belongs to the class of antifolate antineoplastic agents and is specifically approved for treating nonsquamous non-small cell lung cancer, working by preventing the formation of DNA and RNA that cancer cells need to divide and grow. Docetaxel - A chemotherapy medication administered intravenously that works by disrupting the cellular structure of cancer cells during division. It belongs to the taxane family of drugs and is commonly used as a second-line treatment for advanced non-small cell lung cancer, functioning by preventing cancer cells from dividing and multiplying.

Investigated diseases

Non-small Cell Lung Cancer - A type of lung cancer that begins in the large cells of the lungs, including squamous cells and adenocarcinomas. It develops when cells in the lungs grow uncontrollably, forming tumors that can spread to nearby tissues. The disease typically starts in the cells lining the bronchi and parts of the lung such as the bronchioles or alveoli. Initially, it may not cause noticeable symptoms, but as it progresses, it can lead to persistent coughing, chest pain, and breathing difficulties. This cancer grows and spreads more slowly than small cell lung cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518761-10-00Protocol codeMK-3475-01HEstimated enrolment96 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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