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Study of Lurbinectedin and Pembrolizumab for Patients with Relapsed 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 Small Cell Lung Cancer (SCLC). The study is investigating a combination of two treatments: lurbinectedin and pembrolizumab. Lurbinectedin, also known by its code name PM01183, is a medication that is used to treat cancer by interfering with the growth of cancer cells. Pembrolizumab, marketed as KEYTRUDA, is an immunotherapy drug that helps the immune system recognize and attack cancer cells.

The purpose of this study is to explore the safety and effectiveness of these two drugs when used together in patients whose SCLC has returned after initial treatment. The study is divided into two stages. In the first stage, researchers aim to find the best dose of lurbinectedin to use with pembrolizumab. In the second stage, they will assess how well this combination works in treating the cancer. Participants will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein.

Throughout the study, participants will be monitored for any side effects and the response of their cancer to the treatment. This will involve regular check-ups and imaging tests like CT scans or MRI to track the size and spread of the cancer. The study will help determine if this combination of treatments can provide a new option for patients with relapsed SCLC.

The research process

The trial runs in 7 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 participant must have a confirmed diagnosis of small cell lung cancer that has progressed after initial treatment.

    The participant must provide a tumor tissue sample for analysis and meet specific health criteria, including adequate organ function and a performance status evaluation.

  2. Step 2

    Stage I: dose determination

    The first stage involves determining the maximum tolerated dose (MTD) and recommended dose (RD) of lurbinectedin in combination with pembrolizumab.

    Participants receive the study drugs through intravenous infusion. The dosage is adjusted based on the occurrence of any significant side effects during the first cycle of treatment.

  3. Step 3

    Stage II: efficacy assessment

    In the second stage, the effectiveness of the drug combination is evaluated. This involves measuring the response of the cancer to the treatment using imaging techniques like CT scans or MRIs.

    Assessments occur every two cycles to monitor any changes in the size or presence of tumors.

  4. Step 4

    Treatment administration

    Participants receive lurbinectedin and pembrolizumab through intravenous infusion. The frequency and duration of administration depend on the stage of the trial and individual response to treatment.

    The treatment continues until there is evidence of disease progression or unacceptable side effects occur.

  5. Step 5

    Safety and side effects monitoring

    Throughout the trial, any side effects are closely monitored and graded according to established criteria.

    Adjustments to the treatment plan, such as dose reductions or delays, may be made based on the participant's tolerance to the drugs.

  6. Step 6

    Pharmacokinetics and pharmacogenetics

    Blood samples are collected to study how the body processes the drugs and to identify any genetic factors that might affect drug metabolism.

    These analyses help understand individual differences in drug response and potential side effects.

  7. Step 7

    Biomarker research

    Molecular assessments are conducted using plasma samples to explore patterns that may indicate sensitivity or resistance to the treatment.

    This research aims to identify biomarkers that could predict treatment outcomes.

Who can join the trial?

10 criteria

  • Participants must be at least 18 years old and have a confirmed diagnosis of small cell lung cancer (SCLC) that has worsened after initial chemotherapy treatment.
  • Participants in certain stages of the study must have a measurable disease and documented disease progression during or right after their last therapy.
  • It must be at least 4 weeks since the participant's last cancer treatment.
  • Male participants must agree to use contraception during the study and for at least 190 days after the last dose, and they should not donate sperm during this time.
  • Female participants must not be pregnant or breastfeeding. They must either not be able to have children or agree to use contraception during the study and for at least 7 months after the last dose.
  • Participants or their legal representatives must provide written consent to join the trial.
  • Participants must provide a sample of their tumor tissue, either from a previous biopsy or a new one, preferably not from an area that has been treated with radiation.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which is a scale used to assess how a patient's disease is affecting their daily living abilities.
  • Participants must have adequate organ function, as defined by specific medical tests, within 10 days before starting the study treatment.
  • Participants must have recovered to a certain level from any side effects of previous treatments, except for hair loss, skin issues, nerve damage, or weakness, which are allowed if they are mild or can be corrected with supplements.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer other than small cell lung cancer (SCLC) cannot participate. SCLC is a specific type of lung cancer.
  • Patients who have not experienced a return of their SCLC after treatment are not eligible. "Relapsed" means the cancer has come back after treatment.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are part of a vulnerable population, such as those unable to give consent, are not eligible. A vulnerable population includes people who might not be able to make decisions for themselves.
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Investigated drugs

  • Lurbinectedin

    is a medication being studied for its potential to treat relapsed small cell lung cancer. It is being tested to find the best dose that can be used safely and effectively in combination with another medication. The goal is to see how well it works in shrinking or controlling the cancer.

  • Pembrolizumab

    is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. In this study, it is used in combination with lurbinectedin to see if the two medications together can improve treatment outcomes for patients with relapsed small cell lung cancer.

What is already known about the treatment

  • Lurbinectedin

    This medication is administered intravenously and is currently being studied in combination with pembrolizumab for the treatment of relapsed small cell lung cancer (SCLC). It is in the clinical trial phase, specifically in a Phase I/II study, to determine its maximum tolerated dose and efficacy. Lurbinectedin works by binding to the DNA in cancer cells, disrupting their replication and leading to cell death. It is classified as an antineoplastic agent, specifically a DNA-binding agent.

  • Pembrolizumab

    This medication is administered intravenously and is being tested in combination with lurbinectedin for relapsed small cell lung cancer (SCLC). Pembrolizumab is an established medication, widely used in oncology, and is currently part of a Phase I/II clinical trial to evaluate its effectiveness in combination therapy. It functions by blocking the PD-1 pathway, enhancing the immune system's ability to detect and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor.

Investigated diseases

Small Cell Lung Cancer (SCLC) – Small Cell Lung Cancer is a fast-growing type of lung cancer that primarily arises in the bronchi, which are the main air passages to the lungs. It is characterized by small cells that multiply quickly and form large tumors, often spreading to other parts of the body, including the lymph nodes, liver, bones, adrenal glands, and brain. SCLC is strongly associated with smoking and is less common than non-small cell lung cancer. The disease typically progresses rapidly, with symptoms such as coughing, chest pain, and difficulty breathing appearing as the cancer grows and spreads. Due to its aggressive nature, SCLC often presents at an advanced stage, making early detection challenging.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514206-31-00Protocol codeMEDOPP300Estimated enrolment21 patientsSponsorDr.Antonio Calles Blanco

sourced from the EU Clinical Trials Register and site verification

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