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Study of Ifinatamab Deruxtecan with Atezolizumab and Carboplatin for Patients with Extensive-Stage Small Cell Lung Cancer

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 clinical trial is focused on studying a type of lung cancer known as Extensive-stage Small Cell Lung Cancer (ES-SCLC). The study is testing a new treatment called Ifinatamab deruxtecan, also known by its code name DS-7300a. This treatment is a special type of medicine called an antibody-drug conjugate, which is designed to target cancer cells more precisely. The study will also involve other medications, including Atezolizumab, a monoclonal antibody that helps the immune system fight cancer, and Carboplatin, a chemotherapy drug that kills cancer cells. Another drug, Etoposide, which is a topoisomerase inhibitor, may also be used in the study.

The purpose of this study is to assess the safety and tolerability of the combination of these treatments. Participants will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will be conducted in two parts. In the first part, participants will receive Ifinatamab deruxtecan along with Atezolizumab, with or without Carboplatin, as a first-line treatment. In the second part, the study will continue to monitor the effects of these treatments over time. The study aims to understand how well these treatments work together and how they affect the participants' health.

Throughout the study, participants will have regular check-ups to monitor their health and any side effects they may experience. These check-ups will include various tests and assessments to ensure the safety of the participants and to gather information about how the treatments are working. The study is expected to continue until 2026, providing valuable insights into the potential benefits and risks of these treatments for people with Extensive-stage Small Cell 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

    Enrollment

    Sign the informed consent form to confirm understanding and agreement to participate in the study.

    Ensure compliance with eligibility criteria, including age, diagnosis of extensive-stage small cell lung cancer, and adequate organ function.

  2. Step 2

    Treatment initiation

    Begin treatment with ifinatamab deruxtecan and atezolizumab, administered intravenously as a solution for infusion.

    For some participants, carboplatin may also be included in the treatment regimen.

  3. Step 3

    Treatment cycles

    Receive treatment in cycles, with each cycle consisting of specific doses of the medications.

    The treatment plan may include up to 4 cycles of carboplatin.

  4. Step 4

    Monitoring and assessments

    Undergo regular monitoring of health status, including vital signs, laboratory tests, and imaging studies such as CT or MRI scans.

    Assessments will focus on safety, tolerability, and response to treatment.

  5. Step 5

    Follow-up

    Continue follow-up visits to monitor long-term effects and overall health.

    Follow-up includes assessments of progression-free survival, overall survival, and other health outcomes.

Who can join the trial?

12 criteria

  • Sign and date the informed consent form before starting any study-specific procedures.
  • Men must not freeze or donate sperm from the time they join the study until at least 6 months after the last dose of certain study drugs. They may consider preserving sperm before joining the study.
  • Women must not donate or retrieve eggs for their own use from the time they join the study until at least 8 months after the last dose of certain study drugs.
  • Be willing and able to attend scheduled visits, follow the drug plan, undergo lab tests, and follow study rules.
  • Be an adult, at least 18 years old or the legal adult age, whichever is greater, when signing the consent form.
  • Have a confirmed diagnosis of **Extensive-stage Small Cell Lung Cancer (ES-SCLC)**, which is a type of lung cancer.
  • For certain parts of the study, have received specific prior treatments for ES-SCLC or have not received any prior treatment, depending on the study group.
  • For certain parts of the study, have at least one measurable tumor as seen on a **CT scan** or **MRI**, which are imaging tests.
  • For certain parts of the study, have at least one tumor that can be biopsied, and agree to provide tissue samples before and during treatment.
  • Have an **ECOG Performance Status** of 0 or 1, which is a scale used to assess how well a person can perform daily activities.
  • Have adequate organ function as specified in the study protocol, checked within 7 days before starting the study treatment.
  • If a woman can become pregnant, she must have a negative pregnancy test before joining the study. Both men and women who can have children must agree to use effective birth control or avoid intercourse during the study and for a specified time after the last dose of study drugs.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer than Extensive-stage Small Cell Lung Cancer (ES-SCLC) cannot participate. This is a specific type of lung cancer that has spread widely in the body.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups, but the exact ages are not specified here.
  • Patients who are not able to safely receive the study treatments cannot participate. This means if the treatments could harm the patient, they should not join the study.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who have certain medical conditions that could interfere with the study treatments cannot participate. This means if a patient has other health issues that could affect how the study treatments work, they should not join.
  • Patients who are part of a vulnerable population that requires special protection cannot participate. This includes groups of people who might need extra care or consideration.
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Investigated drugs

  • Ifinatamab Deruxtecan (I-DXd)

    is a medication being studied for its potential to treat extensive-stage small cell lung cancer. It is a type of drug known as an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and kill cancer cells. The goal of using Ifinatamab Deruxtecan in this trial is to evaluate its safety and how well it is tolerated by patients when used in combination with other treatments.

  • Atezolizumab

    is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It is used in this trial to see if it can enhance the effects of Ifinatamab Deruxtecan in treating extensive-stage small cell lung cancer. Atezolizumab works by blocking a protein that prevents the immune system from attacking cancer cells, thereby boosting the body's natural defenses against the cancer.

  • Carboplatin

    is a chemotherapy drug that is sometimes used in combination with other treatments to help kill cancer cells. In this trial, carboplatin is used in some patients to see if it can improve the effectiveness of the treatment regimen that includes Ifinatamab Deruxtecan and Atezolizumab. It works by damaging the DNA of cancer cells, which prevents them from growing and dividing.

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 extensive-stage small cell lung cancer (ES-SCLC). It is an antibody-drug conjugate that targets the B7-H3 protein, which is often overexpressed in cancer cells, allowing for targeted delivery of the drug to the tumor. The medication is classified as an antibody-drug conjugate, combining a monoclonal antibody with a cytotoxic agent to kill cancer cells.

  • Atezolizumab

    This medication is given through an intravenous infusion and is approved for use in various cancers, including lung cancer. It is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, helping the immune system recognize and attack cancer cells. Atezolizumab is classified as an immunotherapy drug and is used to enhance the body's natural defenses against cancer.

  • Carboplatin

    Administered intravenously, carboplatin is a well-established chemotherapy drug used in the treatment of various cancers, including lung cancer. It works by interfering with the DNA of cancer cells, preventing them from dividing and growing. Carboplatin is classified as a platinum-based chemotherapy agent and is often used in combination with other cancer treatments to improve outcomes.

Investigated diseases

Extensive-stage Small Cell Lung Cancer (ES-SCLC) – This is a type of lung cancer characterized by the rapid growth and spread of small cancer cells throughout the lungs and often to other parts of the body. It is known for its aggressive nature and tendency to metastasize early, affecting organs such as the liver, brain, and bones. The disease typically begins in the central airways of the lungs and can cause symptoms like coughing, chest pain, and difficulty breathing. As it progresses, it may lead to more systemic symptoms such as weight loss and fatigue. The extensive stage indicates that the cancer has spread beyond the lung to other areas, making it more challenging to manage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509629-36-00Protocol codeDS7300-189Estimated enrolment153 patientsSponsorDaiichi Sankyo Inc.

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