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Study of Ifinatamab Deruxtecan for Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer

Verified siteInvestigationalNo 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 Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The treatment being tested is called Ifinatamab deruxtecan, which is also known by its code name DS-7300a. This treatment is a special kind of medicine called an Antibody Drug Conjugate (ADC), which is designed to target and attack cancer cells more precisely.

The purpose of the study is to evaluate how well Ifinatamab deruxtecan works in patients who have already received treatment for their lung cancer. Participants in the study will receive the treatment through an infusion, which means the medicine is given directly into the bloodstream through a vein. The study will follow participants over a period of time to observe the effects of the treatment on their cancer.

Throughout the study, participants will have regular visits to monitor their health and the progress of their cancer. These visits will include various tests and assessments to ensure the safety and effectiveness of the treatment. The study aims to provide valuable information on the potential benefits of Ifinatamab deruxtecan for patients with pretreated ES-SCLC.

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

    Enrollment

    Upon joining the study, the patient will be required to sign and date the informed consent form. This is necessary before any study-specific procedures can begin.

    The patient must meet specific health criteria, including certain blood test results and a negative pregnancy test for females of childbearing potential.

  2. Step 2

    Initial Assessment

    The patient will undergo a series of baseline tests, including laboratory tests and imaging, to confirm eligibility and establish a starting point for the study.

    A biopsy of a tumor lesion will be required unless a recent suitable sample is available.

  3. Step 3

    Treatment Administration

    The patient will receive the study medication, ifinatamab deruxtecan, which is administered as a solution for infusion through an intravenous route.

    The treatment will be given in cycles, with the specific schedule and dosage determined by the study protocol.

  4. Step 4

    Regular Monitoring

    Throughout the treatment period, the patient will have regular visits for monitoring. This includes physical exams, blood tests, and imaging to assess the response to the medication.

    The patient must comply with all scheduled visits and procedures as outlined in the study plan.

  5. Step 5

    Follow-up

    After completing the treatment cycles, the patient will continue to be monitored for a specified period to evaluate long-term effects and overall health.

    The follow-up period includes additional tests and assessments as required by the study.

Who can join the trial?

15 criteria

  • Sign and date the informed consent form before starting any study-specific procedures.
  • Have certain laboratory test results within specific ranges before starting the study. These tests include liver function tests, blood cell counts, kidney function, and blood clotting tests.
  • If female and able to have children, must have a negative pregnancy test before the first dose and agree to use effective birth control during the study and for 7 months after the last dose.
  • If male, must be surgically sterile or agree to use effective birth control during the study and for 4 months after the last dose.
  • Male participants must not freeze or donate sperm during the study and for 4 months after the last dose. Sperm preservation can be considered before joining the study.
  • Female participants must not donate or retrieve eggs during the study and for 7 months after the last dose. They should not breastfeed during this time. Egg preservation can be considered before joining the study.
  • Be willing and able to attend scheduled visits, follow the drug administration plan, undergo laboratory tests, and comply with other study procedures and restrictions.
  • Have at least one tumor that can be biopsied and agree to provide a tissue sample before and during treatment. If a recent biopsy sample is available, it may be used instead.
  • Be 18 years or older.
  • Have a confirmed diagnosis of **Extensive-stage Small Cell Lung Cancer (ES-SCLC)**.
  • Have at least one measurable tumor according to specific guidelines.
  • Have received at least one prior treatment with platinum-based chemotherapy for extensive-stage disease, with at least two cycles of therapy. Must not have had more than three previous lines of systemic therapy.
  • Show disease progression on or after the most recent systemic therapy.
  • Have an **ECOG Performance Status** of 0 or 1, which means being fully active or having some restrictions but able to carry out light work.
  • Have a life expectancy of at least 3 months.

Who cannot join the trial?

3 criteria

  • Patients who have not been previously treated for **Extensive-stage Small Cell Lung Cancer (ES-SCLC)** cannot participate. **Extensive-stage Small Cell Lung Cancer** is a type of lung cancer that has spread widely in the body.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who belong to a vulnerable population, which means groups that might need special protection or care, cannot participate.
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Investigated drugs

Ifinatamab Deruxtecan (I DXd) is a medication being studied for its potential to treat patients with extensive-stage small cell lung cancer (ES-SCLC) who have already received other treatments. It is a type of drug known as an antibody-drug conjugate (ADC), which combines an antibody with a drug to specifically target and attack cancer cells. The goal of this study is to evaluate how effective this medication is in reducing or controlling the growth of cancer in these patients.

What is already known about the treatment

Ifinatamab Deruxtecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating pretreated extensive-stage small cell lung cancer (ES-SCLC). It is an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target cancer cells. The main therapeutic indication is for patients who have already received treatment for ES-SCLC. At the molecular level, it works by binding to the B7-H3 protein on cancer cells, delivering a cytotoxic agent directly to the tumor, which helps to kill the cancer cells. It falls under the pharmacological classification of targeted cancer therapies.

Investigated diseases

Extensive-stage Small Cell Lung Cancer (ES-SCLC) – This is a type of lung cancer characterized by small cells that grow rapidly and spread quickly throughout the body. It is called "extensive-stage" when the cancer has spread beyond the lungs to other parts of the body. The disease often begins in the central airways and can quickly invade nearby tissues and organs. Symptoms may include coughing, chest pain, and difficulty breathing. As the disease progresses, it can lead to more severe respiratory issues and systemic symptoms. The rapid growth and spread make it a challenging condition to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512368-79-00Estimated enrolment187 patientsSponsorDaiichi Sankyo Inc.

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