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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

  • Raludotatug Deruxtecan

    is an experimental medicine being tested as a single‑agent treatment for people with advanced non‑small cell lung cancer. It is given through an IV infusion. In the study, researchers are looking at how well it can shrink tumors and how safe it is for patients.

  • Docetaxel

    is a chemotherapy drug that works by stopping cancer cells from dividing and growing. In this trial it is used as a single‑agent therapy to see how effective it is against previously treated stage IV nonsquamous non‑small cell lung cancer and to monitor its safety profile.

  • Ifinatamab Deruxtecan

    is another investigational medicine designed to target cancer cells and deliver a powerful cell‑killing agent directly to them. Like the other drugs, it is given by IV infusion and is being studied on its own to evaluate tumor response and any side effects in patients with advanced non‑small cell lung cancer.

What is already known about the treatment

  • Raludotatug Deruxtecan

    It is administered by intravenous infusion as a solution for infusion, typically at a dose of about 5.6 mg per kilogram of body weight. The drug is still investigational and is being studied in clinical trials for previously treated non‑small cell lung cancer. It works by linking a chemotherapy payload to an antibody that binds a protein found on cancer cells, delivering the toxin directly to the tumor while limiting exposure to healthy cells. It is classified as an antibody‑drug conjugate.

  • Docetaxel

    It is given as an intravenous infusion, usually at 75 mg per square meter of body surface area, using a standard chemotherapy solution. Docetaxel is an approved cancer medicine and is widely used for many solid tumors, including non‑small cell lung cancer. The drug stops cancer cells from dividing by stabilizing tiny structures called microtubules, which are needed for cell division. It belongs to the taxane class of chemotherapy agents.

  • Ifinatamab Deruxtecan

    This medication is delivered by intravenous infusion as a solution for infusion, at a dose of about 12 mg per kilogram of body weight. It is currently experimental and is being evaluated in trials for patients with previously treated non‑small cell lung cancer. The drug combines an antibody that targets a tumor‑associated protein with a chemotherapy payload, allowing it to release the toxin inside cancer cells while sparing most normal tissue. It is also classified as an antibody‑drug conjugate.

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 21 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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