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Study Comparing Sacituzumab Govitecan and Standard Treatment for Patients with Previously Treated Extensive Stage Small Cell Lung Cancer

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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 will compare the effects of a medication called Sacituzumab Govitecan, also known by its brand name Trodelvy, with the standard treatments currently used for this type of cancer. Sacituzumab Govitecan is a special kind of treatment called an Antibody-Drug Conjugate, which is designed to target and attack cancer cells more precisely.

The purpose of the study is to see how well Sacituzumab Govitecan works compared to the usual treatments in improving the condition of patients with ES-SCLC. Participants in the study will receive either Sacituzumab Govitecan or the standard treatment, which may include other medications. The study will monitor how the cancer responds to the treatment and how long patients live after receiving the treatment. Some participants may receive a placebo as part of the study.

The study will take place over a period of time, with regular check-ups and assessments to track the progress of the treatment. Participants will receive their treatment through an intravenous method, which means the medication will be given directly into a vein. The study aims to provide valuable information on the effectiveness of Sacituzumab Govitecan in treating ES-SCLC and to explore its potential as a new treatment option for patients with this type of 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

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either the new treatment, sacituzumab govitecan, or the current standard of care for your condition. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Treatment administration

    If you are assigned to the sacituzumab govitecan group, you will receive the medication as an intravenous infusion. This means the medication will be given directly into your vein through a needle.

    The dosage for sacituzumab govitecan is 200 mg, and it will be administered as a solution for infusion. The frequency and duration of the treatment will be explained to you by the study team.

    If you are assigned to the standard of care group, you will receive the current treatment used for extensive stage small cell lung cancer, which may also involve intravenous administration.

  3. Step 3

    Monitoring and assessments

    Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging tests such as CT or MRI scans to assess the response of your cancer to the treatment.

    The study team will evaluate the effect of the treatment on your cancer using specific criteria to determine if there is a complete or partial response.

  4. Step 4

    Reporting side effects

    You will be asked to report any side effects or changes in your health to the study team. This information is crucial for understanding the safety of the treatment.

    The study team will also monitor for any treatment-emergent adverse events, which are side effects that occur after the treatment has started.

  5. Step 5

    End of study participation

    Your participation in the study will continue until the study ends or until you and the study team decide it is best for you to stop. The estimated end date for the study is November 1, 2029.

    At the end of your participation, you will have a final assessment to evaluate your overall health and the effect of the treatment on your cancer.

Who can join the trial?

6 criteria

  • Must have a confirmed diagnosis of Small Cell Lung Cancer (SCLC).
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but nearly fully active.
  • Must have a disease that can be measured by computed tomography (CT) or magnetic resonance imaging (MRI). These are imaging tests that help doctors see inside the body.
  • Must have documentation showing that the disease has gotten worse after receiving at least one previous treatment with platinum-containing chemotherapy. This treatment should have included at least two cycles. It may have been given with or without therapy targeting programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1). These are proteins that can affect the immune system's ability to fight cancer.
  • Participants can be of any gender.
  • Participants must be within the age range of adults and older adults.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides Extensive Stage Small Cell Lung Cancer (ES-SCLC) cannot participate.
  • Patients who have not fully recovered from previous cancer treatments are excluded.
  • Patients with severe heart problems are not eligible.
  • Patients with uncontrolled infections cannot join the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients with a history of severe allergic reactions to similar drugs are excluded.
  • Patients with brain metastases that are causing symptoms are not eligible. Brain metastases are cancer cells that have spread to the brain.
  • Patients who have received another investigational drug within the last 4 weeks cannot participate.
  • Patients with autoimmune diseases that are not well controlled are excluded. Autoimmune diseases are conditions where the immune system attacks the body.
  • Patients with a history of drug or alcohol abuse that could interfere with the study are not eligible.
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Investigated drugs

Sacituzumab Govitecan is a medication being studied for its potential to treat extensive stage small cell lung cancer that has already been treated with other therapies. It works by combining an antibody with a chemotherapy drug. The antibody part of the medication helps to target and attach to cancer cells, while the chemotherapy part helps to kill these cells. This combination aims to improve the response to treatment and potentially extend the life of patients with this type of lung cancer.

What is already known about the treatment

Sacituzumab Govitecan – Sacituzumab Govitecan, also known by its trade name Trodelvy, is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating Extensive Stage Small Cell Lung Cancer (ES-SCLC) after other treatments have been tried. This medication works by delivering a toxic substance directly to cancer cells, which helps to kill them while minimizing damage to normal cells. It belongs to a class of drugs known as antibody-drug conjugates, which are designed to target and destroy cancer cells specifically.

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 cells in the lung tissue. It is called "extensive stage" when the cancer has spread beyond the lung to other parts of the body. The disease progresses quickly, often involving the lymph nodes and other organs. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer advances, it can lead to more severe respiratory issues and systemic symptoms. The progression is typically aggressive, with a tendency to metastasize early in its course.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515884-69-00Protocol codeGS-US-600-6165Estimated enrolment712 patientsSponsorGilead Sciences Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).