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Study of Lurbinectedin Alone or with Irinotecan for Patients with Relapsed 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 treatments for Small Cell Lung Cancer (SCLC), a type of lung cancer that tends to grow and spread quickly. The study is investigating the effectiveness of a drug called lurbinectedin, both as a single treatment and in combination with another drug called irinotecan. Additionally, the study will compare these treatments to the investigator's choice of either topotecan or irinotecan. Lurbinectedin is a medication that is being tested to see if it can help patients whose cancer has returned after initial treatment.

The purpose of the study is to determine if there is a difference in overall survival between the different treatment groups. Participants will be randomly assigned to one of three groups: one group will receive lurbinectedin alone, another group will receive lurbinectedin combined with irinotecan, and the third group will receive either topotecan or irinotecan as chosen by the study investigator. The study will monitor participants over a period to assess how well the treatments work and to observe any side effects.

Throughout the study, participants will receive their assigned treatment and will be regularly monitored by healthcare professionals. The study aims to provide valuable information on the potential benefits and safety of these treatments for patients with relapsed SCLC. The results could help improve future treatment options for this aggressive form of 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

    Joining the study

    Upon joining the study, the patient is assigned to one of three groups. Each group receives a different treatment regimen for relapsed small cell lung cancer (SCLC).

  2. Step 2

    Treatment group assignment

    Group A receives lurbinectedin as a single agent.

    Group B receives a combination of lurbinectedin and irinotecan.

    Group C receives either topotecan or irinotecan, based on the investigator's choice.

  3. Step 3

    Medication administration

    All medications are administered through intravenous use.

    The specific dosage and frequency of administration are determined by the study protocol and the patient's assigned group.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's health and response to treatment are closely monitored.

    Regular assessments are conducted to evaluate overall survival, progression-free survival, and response rate.

  5. Step 5

    Safety and outcomes evaluation

    The safety profile of the treatment is assessed, including any side effects experienced by the patient.

    Patient-reported outcomes are collected to understand the impact of the treatment on quality of life.

  6. Step 6

    End of trial participation

    The trial is estimated to conclude by October 31, 2025.

    Upon completion, the patient's overall health and treatment outcomes are reviewed.

Who can join the trial?

16 criteria

  • The patient must provide voluntary written consent before any study-related procedures begin.
  • If the patient had prior radiation treatment, at least two weeks must have passed since the completion of radiation to the brain or any other area.
  • Women who can have children must show they are not pregnant and agree to use a highly effective birth control method for up to seven months after stopping treatment. Men with partners who can have children should use condoms during treatment and for four months after the last dose of the study drug.
  • The patient must be 18 years or older.
  • The patient must have a confirmed diagnosis of **Small Cell Lung Cancer (SCLC)** through a tissue sample or cell study.
  • The patient must have had one previous treatment with a platinum-based chemotherapy, with or without certain immune therapies (at least 70% of patients in the study should have had these immune therapies).
  • The time between the last dose of the first-line platinum chemotherapy and the worsening of the disease must be at least 30 days.
  • Patients with a history of cancer spread to the brain can participate if they have been treated and are stable for at least four weeks, show no symptoms, and do not need steroid treatment for at least seven days before starting the study treatment.
  • The patient must have an **Eastern Cooperative Oncology Group (ECOG) Performance Status** of 2 or less, which means they are able to carry out all self-care but are unable to carry out any work activities.
  • The patient must have adequate blood, kidney, liver, and metabolic function, including:
    • Hemoglobin levels of at least 9.0 g/dL (patients may have received a blood transfusion if needed).
    • A certain level of white blood cells and platelets.
    • Liver enzymes (ALT and AST) should be no more than three times the upper normal limit.
    • Total bilirubin should be no more than 1.5 times the upper normal limit, or direct bilirubin should be within the normal range.
    • Albumin levels of at least 3.0 g/dL.
    • Kidney function, measured by creatinine clearance, should be at least 30 mL/min.
    • At least three weeks must have passed since the last cancer treatment, and any side effects from previous treatments should have improved to a mild level, except for certain conditions like mild nerve damage, anemia, weakness, and hair loss.

Who cannot join the trial?

7 criteria

  • Patients who have not experienced a return of their Small Cell Lung Cancer (SCLC) after treatment with a platinum-containing chemotherapy cannot participate. This means the cancer must have come back after a specific type of chemotherapy treatment.
  • Patients who have not received any prior treatment with a platinum-containing chemotherapy are not eligible. This means they must have had a specific type of chemotherapy before.
  • Patients who are not within the specified age range cannot participate. The study is for adults only.
  • Patients who are not able to understand or follow the study procedures cannot participate. This means they need to be able to understand what the study involves and follow instructions.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients with other serious health conditions that might interfere with the study cannot participate. This means if they have other health problems that could affect the study results, they are not eligible.
  • Patients who have participated in another clinical trial recently cannot participate. This is to avoid any interference from other treatments or studies.
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Investigated drugs

  • Lurbinectedin

    is a medication being studied for its effectiveness in treating relapsed small cell lung cancer. It is being tested both as a single agent and in combination with another drug, irinotecan, to see if it can help improve overall survival in patients who have already been treated with a platinum-containing chemotherapy.

  • Irinotecan

    is a chemotherapy drug that is used in this trial in combination with lurbinectedin. It is also one of the options available to doctors in the study to compare its effectiveness against other treatments. Irinotecan works by interfering with the DNA of cancer cells, which can help stop their growth and spread.

  • Topotecan

    is another chemotherapy drug that is being used as a comparison treatment in this study. It is one of the options that doctors can choose for patients in the trial. Topotecan works by inhibiting an enzyme that cancer cells need to grow, which can help slow down or stop the progression of the disease.

What is already known about the treatment

Lurbinectedin – Lurbinectedin is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed small cell lung cancer (SCLC). It is being evaluated both as a single agent and in combination with irinotecan. The medication works by binding to the DNA in cancer cells, disrupting their ability to replicate and ultimately leading to cell death. Lurbinectedin is classified as an antineoplastic agent, specifically a DNA-binding agent, and is being investigated for its potential to improve overall survival in patients who have not responded to previous chemotherapy treatments.

Investigated diseases

Small Cell Lung Cancer (SCLC) – 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. SCLC often starts in the bronchi, which are the main airways of the lungs, and can spread rapidly to other parts of the body, including the lymph nodes, liver, bones, and brain. The disease is typically divided into two stages: limited stage, where cancer is confined to one lung and possibly nearby lymph nodes, and extensive stage, where it has spread beyond that. Symptoms may include coughing, chest pain, shortness of breath, and weight loss. Due to its aggressive nature, SCLC is often diagnosed at an advanced stage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513559-34-00Protocol codePM1183-C-008-21Estimated enrolment698 patientsSponsorPharma Mar S.A.

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