Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

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

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating patients with Stage IV Squamous Non-Small Cell Lung Cancer who have previously received other treatments. The study will test three different medications: Raludotatug Deruxtecan (also known as MK-5909), Ifinatamab Deruxtecan (also known as MK-2400), and docetaxel. These medications are given through intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The main purpose of this study is to determine how well these treatments work in fighting lung cancer and to evaluate their safety when used individually. The medications will be administered over a period of up to 24 months, with different dosing schedules for each drug. Raludotatug Deruxtecan will be given at doses up to 5.6 mg per kilogram of body weight, ifinatamab deruxtecan at doses up to 12 mg per kilogram, and docetaxel at doses up to 75 mg per square meter of body surface area.

During the study, doctors will monitor how the cancer responds to treatment and track any side effects that may occur. The study will measure how many patients' tumors shrink or disappear, how long the treatment effects last, how long patients live without their cancer getting worse, and overall survival time. This research is part of a larger study called KEYMAKER-U01, which is investigating various treatment options for lung cancer.

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 screening and eligibility confirmation

    Medical evaluation to confirm stage IV squamous non-small cell lung cancer diagnosis

    Verification of previous treatments including anti-PD-(L)1 treatment and platinum-based chemotherapy

    Assessment of disease progression using medical imaging

  2. Step 2

    Treatment assignment

    Random assignment to one of three treatment groups:

    Group 1: Raludotatug Deruxtecan given through intravenous infusion

    Group 2: Ifinatamab Deruxtecan given through intravenous infusion

    Group 3: Docetaxel given through intravenous infusion

  3. Step 3

    Treatment period

    Regular visits to receive assigned medication through intravenous infusion

    Monitoring of treatment response through medical imaging

    Regular health assessments to check for side effects

    Documentation of any adverse reactions to the treatment

  4. Step 4

    Response evaluation

    Regular assessment of tumor response using medical imaging

    Evaluation of how long the treatment remains effective

    Monitoring of cancer progression

    Assessment of overall health status

  5. Step 5

    Long-term follow-up

    Continued monitoring of health status

    Regular check-ups to assess long-term treatment effects

    Documentation of survival outcomes

    Study participation continues until March 2032

Who can join the trial?

7 criteria

  • Must have confirmed Stage IV squamous non-small cell lung cancer through tissue or cell examination

  • Must show disease progression after receiving two types of previous treatments:

    • Treatment targeting PD-L1 (a protein that helps control immune system responses)
    • Platinum-based chemotherapy (a standard type of cancer treatment)
  • Must be an adult (18 years or older)
  • Both men and women can participate
  • If living with HIV, must have the condition well controlled with antiviral medications

  • If positive for Hepatitis B, must have:

    • Been on antiviral treatment for at least 4 weeks
    • No detectable virus in blood tests
  • If having a history of Hepatitis C, must have no detectable virus in blood tests

Who cannot join the trial?

13 criteria

  • Patients with a history of small cell lung cancer (a different type of lung cancer)
  • Patients who have received any prior systemic cancer therapy for stage IV disease
  • Patients with active or untreated brain metastases (cancer that has spread to the brain)
  • Patients with known autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Patients who have received live vaccines within 30 days before starting the study treatment
  • Patients with active infections requiring systemic treatment
  • Patients with uncontrolled cardiovascular disease (serious heart conditions)
  • Pregnant or breastfeeding women
  • Patients participating in other clinical trials within 30 days before this study
  • Patients with known hypersensitivity to the study medications
  • Patients unable to swallow oral medications
  • Patients with severe liver or kidney dysfunction
  • Patients with uncontrolled diabetes or other serious medical conditions
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Docetaxel

    is a chemotherapy medicine that is already used to treat lung cancer. In this study it serves as the standard treatment that the new drugs are compared against. It is given through an IV infusion and works by stopping cancer cells from growing and dividing.

  • Ifinatamab Deruxtecan

    is an experimental therapy being tested in the trial. It belongs to a class of medicines called antibody‑drug conjugates, which are designed to find cancer cells and deliver a strong chemotherapy agent directly to them. The goal is to attack the tumor while causing less damage to healthy tissue. It is given as an IV infusion and is used alone (monotherapy) in the study.

  • Raludotatug Deruxtecan

    is another investigational antibody‑drug conjugate evaluated in the trial. Like other drugs in its class, it aims to target cancer cells specifically and release a chemotherapy payload inside those cells. This approach hopes to improve effectiveness and reduce side effects compared with traditional chemotherapy. It is also administered by IV infusion as a single‑agent treatment.

What is already known about the treatment

  • Docetaxel

    Docetaxel is administered by intravenous infusion, where a liquid solution is slowly injected into a vein. It is an approved chemotherapy drug that is already used in standard medical practice for several cancers, including lung cancer. It works by attaching to tiny structures called microtubules inside cancer cells, keeping them locked in place and preventing the cells from dividing. It belongs to the taxane class of anticancer agents.

  • Ifinatamab Deruxtecan

    Ifinatamab deruxtecan is given as an intravenous infusion of a clear solution. It is still an investigational drug being studied in clinical trials and is not yet approved for routine use. The medicine combines an antibody that seeks out a specific protein on cancer cells with a chemotherapy payload (deruxtecan) that damages the cell’s DNA when released. It is classified as an antibody‑drug conjugate, a type of targeted cancer therapy.

  • Raludotatug Deruxtecan

    Raludotatug deruxtecan is also delivered by intravenous infusion of a solution. Like ifinatamab deruxtecan, it is an experimental treatment currently evaluated in clinical studies and not yet on the market. It uses an antibody to find cancer cells and then releases the attached deruxtecan payload to break the DNA inside those cells, stopping them from growing. It falls under the pharmacological class of antibody‑drug conjugates.

Investigated diseases

Stage IV Squamous Non-Small Cell Lung Cancer - A form of lung cancer that begins in the flat cells (squamous cells) lining the larger airways of the lungs and has spread extensively throughout the body. This type of cancer develops from the epithelial cells of the lung tissue and is characterized by the distinctive appearance of squamous cells under microscopic examination. The disease progresses through the lungs and can form secondary tumors in other parts of the body. At stage IV, the cancer has spread beyond the lungs to other organs or areas of the body. This condition affects the normal functioning of the lungs and can impact other organs where the cancer has spread.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518839-11-00Protocol codeMK-3475-01IEstimated enrolment158 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.