Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on MK-6070 and Ifinatamab Deruxtecan for Patients with Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

Fast replyRegistered 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 is focused on studying a type of lung cancer known as small cell lung cancer. This is a condition where cancer cells form in the tissues of the lung and can spread quickly to other parts of the body. The study is investigating two treatments: MK-6070 and Ifinatamab Deruxtecan, also known by its code name I-DXd. Both treatments are given as a solution through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and effectiveness of these treatments in people whose cancer has returned or has not responded to previous treatments. The study will be conducted in two parts. In the first part, participants will receive either a combination of MK-6070 and I-DXd or I-DXd alone, to see how well these treatments are tolerated and how effective they are. In the second part, the focus will be on the safety and tolerability of MK-6070 alone in participants in Japan.

Participants in the study will receive the treatments at different times and will be monitored for any side effects or changes in their condition. The study aims to gather information on how the body responds to these treatments, including how long the treatments stay in the body and how they are processed. This information will help researchers understand the potential benefits and risks of these new treatment options for small cell 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of extensive-stage small cell lung cancer and ensuring previous treatment with platinum-based chemotherapy.

    A tissue sample, either archival or fresh biopsy, is required for further analysis.

  2. Step 2

    Treatment phase 1

    The first part of the treatment involves the administration of MK-6070 in combination with ifinatamab deruxtecan (I-DXd) or I-DXd alone. The method of administration is through an intravenous infusion.

    The frequency of I-DXd monotherapy is every two weeks. The combination schedule may vary based on individual assessments.

  3. Step 3

    Monitoring and evaluation

    Throughout the treatment, regular monitoring is conducted to evaluate safety and tolerability. This includes tracking any adverse events or dose-limiting toxicities.

    The objective response rate (ORR) is assessed to determine the effectiveness of the treatment.

  4. Step 4

    Treatment phase 2

    In the second part of the study, participants in Japan receive MK-6070 as a monotherapy. The focus remains on evaluating safety and tolerability.

    The administration continues through intravenous infusion, with specific schedules determined by the study protocol.

  5. Step 5

    Ongoing assessments

    Participants undergo continuous assessments to measure various pharmacokinetic parameters such as maximum concentration and time to maximum concentration of the drugs.

    The duration of response and progression-free survival are also evaluated to understand the long-term effects of the treatment.

  6. Step 6

    Completion and follow-up

    Upon completion of the treatment phases, a follow-up period is conducted to monitor any long-term effects or adverse events.

    The study is estimated to conclude by December 16, 2027, with ongoing evaluations to ensure participant safety and gather comprehensive data.

Who can join the trial?

5 criteria

  • The patient must have **small cell lung cancer** that is in an **extensive stage**. This means the cancer has spread widely in the body. The patient should have already received at least one type of treatment that included **platinum-based chemotherapy**.
  • The patient must be able to provide a sample of their cancer tissue. This can be an **archival tissue sample**, which is a sample taken in the past, or a **fresh biopsy tissue sample**, which is a new sample taken from the body.
  • If the patient is infected with the **human immunodeficiency virus (HIV)**, their HIV must be well controlled with **antiretroviral therapy (ART)**. This means they are taking medication to manage their HIV effectively.
  • The study is open to both male and female participants.
  • The study is not specifically for vulnerable populations, meaning it does not focus on groups that might need special protection or care.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer besides small cell lung cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
  • Patients who have not met the specific health requirements set by the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have certain medical conditions that could interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have allergies to the study medications cannot 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.

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

  • MK-6070

    is a medication being studied for its safety and effectiveness in treating patients with relapsed or refractory extensive-stage small cell lung cancer. In this trial, it is being tested both alone and in combination with another medication to see how well it works and how well patients can tolerate it.

  • Ifinatamab Deruxtecan (I-DXd)

    is another medication involved in this study. It is being evaluated for its safety and effectiveness when used alone or in combination with MK-6070. The study aims to determine the best way to use this medication to help patients with extensive-stage small cell lung cancer who have not responded to previous treatments.

What is already known about the treatment

  • MK-6070

    This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating small cell lung cancer. It is in the investigational stage, meaning it is not yet approved for general medical use. The main therapeutic indication is for patients with relapsed or refractory extensive-stage small cell lung cancer. MK-6070 works by targeting specific proteins involved in cancer cell growth, aiming to inhibit their function and slow down tumor progression. It is classified as an investigational anti-cancer agent.

  • Ifinatamab Deruxtecan (I-DXd)

    This medication is also administered intravenously and is under investigation in clinical trials for its potential to treat small cell lung cancer. It is not yet approved for widespread medical use and is being evaluated for its safety and efficacy. The primary therapeutic use is for patients with relapsed or refractory extensive-stage small cell lung cancer. I-DXd functions by delivering a cytotoxic agent directly to cancer cells, thereby disrupting their growth and survival. It is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

Investigated diseases

Small Cell Lung Cancer – This is a fast-growing type of lung cancer that primarily affects smokers. It is characterized by small cells that multiply quickly and form large tumors. These tumors can spread rapidly to other parts of the body, including the brain, liver, and bones. The disease often starts in the bronchi, which are the main airways of the lungs. As it progresses, it can cause symptoms such as coughing, chest pain, and difficulty breathing. Due to its aggressive nature, it is often diagnosed at an advanced stage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517926-25-00Protocol codeMK-6070-002Estimated enrolment327 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.