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Study on Trilaciclib and Topotecan for Patients with Extensive Stage Small Cell Lung Cancer

Fast replyRegistered 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 evaluating a treatment called Trilaciclib, which is given to patients before they receive a chemotherapy drug named Topotecan. The purpose of the study is to see if Trilaciclib can help patients live longer compared to those who receive a placebo before Topotecan. A placebo is a substance with no active medication, used for comparison in clinical trials.

Participants in the study will receive either Trilaciclib or a placebo before their Topotecan chemotherapy sessions. The study will monitor the overall survival of patients, which means the length of time patients live after starting the treatment. The trial will also look at other factors, such as how the cancer responds to the treatment and any side effects that may occur. The study is designed to last for a period of up to 120 days, during which patients will receive regular intravenous infusions of the study medications.

In addition to Trilaciclib and Topotecan, the study involves the use of other substances like Sodium Chloride and Glucose Monohydrate, which are commonly used in medical settings to support the administration of intravenous treatments. The trial aims to provide valuable information on the effectiveness and safety of using Trilaciclib in combination with Topotecan for treating patients with ES-SCLC.

The research process

The trial runs in 4 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 study medication trilaciclib or a placebo. This is done to compare the effects of the medication with no active treatment.

    You will be informed about the schedule and procedures involved in the study, including the administration of the medication and any necessary follow-up visits.

  2. Step 2

    Medication administration

    The study involves receiving trilaciclib or a placebo through an intravenous infusion. This means the medication is given directly into your vein using a needle.

    The infusion is administered prior to receiving topotecan chemotherapy, which is also given through an intravenous infusion. The exact dosage and frequency will be determined by the study protocol and your healthcare provider.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and other assessments to evaluate your response to the treatment and to ensure your safety.

    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 effects of the treatment.

  4. Step 4

    Completion of the study

    At the end of the study period, you will undergo a final evaluation to assess your overall health and the outcomes of the treatment.

    The study team will discuss the results with you and provide guidance on any further treatment or follow-up care that may be needed.

Who can join the trial?

11 criteria

  • Must be at least 18 years old.
  • Have an ECOG performance status of 0-2, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • Have adequate organ function as shown by specific laboratory tests.
  • Any side effects from previous treatments must be resolved to a certain level, except for some ongoing side effects like hair loss or nerve damage that are not considered risky for further treatment.
  • Must use contraception as per local guidelines if applicable.
  • Must be able to provide informed consent, meaning you understand and agree to the study's requirements.
  • Have a confirmed diagnosis of Extensive Stage Small Cell Lung Cancer (ES-SCLC) through specific medical tests.
  • The cancer must have progressed during or after previous chemotherapy treatments.
  • Must have measurable or evaluable disease as defined by specific medical criteria.
  • Must know the sensitivity status to first-line therapy, meaning how the cancer responded to initial treatment.
  • Must be considered eligible to receive topotecan chemotherapy by the study doctor.

Who cannot join the trial?

3 criteria

  • Patients who do not have Extensive Stage Small Cell Lung Cancer cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population may not be eligible.
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Investigated drugs

  • Trilaciclib

    is a medication being studied to see if it can help protect the bone marrow from damage caused by chemotherapy. The bone marrow is important because it makes blood cells that help fight infections, carry oxygen, and stop bleeding. In this trial, trilaciclib is given before chemotherapy to see if it can help patients with extensive stage small cell lung cancer live longer.

  • Topotecan

    is a type of chemotherapy used to treat small cell lung cancer. It works by stopping cancer cells from growing and dividing. In this study, topotecan is given to patients to see how well it works when used with or without trilaciclib.

What is already known about the treatment

Trilaciclib – Trilaciclib is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its potential use in treating extensive stage small cell lung cancer (ES-SCLC). The main therapeutic indication for Trilaciclib is to improve overall survival in patients with ES-SCLC who are receiving chemotherapy with Topotecan. At the molecular level, Trilaciclib works by protecting the bone marrow from damage caused by chemotherapy, which helps maintain the production of healthy blood cells. It is classified as a cyclin-dependent kinase 4/6 inhibitor, which means it helps regulate cell division and growth.

Investigated diseases

Extensive Stage Small Cell Lung Cancer – This is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It is called "extensive stage" when the cancer has spread beyond the lung to other parts of the body. The disease progresses rapidly, often involving the liver, bones, and brain. Symptoms may include coughing, chest pain, and difficulty breathing. As the cancer advances, it can lead to weight loss, fatigue, and neurological issues. The progression is typically aggressive, with a tendency to metastasize early in its course.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502357-34-00Protocol codeG1T28-211Estimated enrolment335 patientsSponsorPharmacosmos A/S

sourced from the EU Clinical Trials Register and site verification

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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).