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Study of Pembrolizumab, Lenvatinib, and Chemotherapy for First-Line Treatment in Extensive-Stage Small Cell Lung Cancer Patients

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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 explore the effects of a combination treatment that includes the medications pembrolizumab and lenvatinib, along with chemotherapy drugs carboplatin and etoposide. Pembrolizumab is administered as a solution for infusion, while lenvatinib is taken in capsule form. The purpose of the study is to evaluate the safety and effectiveness of this combination treatment in patients who are receiving their first line of treatment for this type of lung cancer.

The study will be conducted in two parts. In the first part, the focus will be on assessing the safety and tolerability of lenvatinib when used with pembrolizumab and chemotherapy. This means checking how well patients can handle the treatment and identifying any side effects. In the second part, the study will look at how long patients can live without their cancer getting worse, which is known as progression-free survival. This will help determine if the combination treatment is effective in controlling the cancer.

Participants in the study will receive the treatment over a period of time, with regular monitoring by healthcare professionals. The study aims to provide valuable information on the potential benefits and risks of using pembrolizumab and lenvatinib together with chemotherapy for treating extensive-stage small cell lung cancer. This research could contribute to improving treatment options for patients with this type of cancer.

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

    Initial treatment phase

    The initial phase involves the administration of medications to evaluate their safety and how well they are tolerated. This phase is known as the safety run-in.

    During this phase, you will receive a combination of medications: lenvatinib at a dose of 8 mg taken orally, pembrolizumab administered through an intravenous infusion, and chemotherapy drugs carboplatin and etoposide.

  2. Step 2

    Treatment phase

    In the treatment phase, the focus is on assessing how long the disease does not progress, known as progression-free survival.

    You will receive lenvatinib at a higher dose of 20 mg taken orally, along with pembrolizumab and the chemotherapy drugs carboplatin and etoposide.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular monitoring will occur to assess the response to treatment and any side effects.

    The effectiveness of the treatment will be evaluated using criteria known as RECIST 1.1, which helps in measuring how the cancer responds to the treatment.

  4. Step 4

    Completion and follow-up

    After completing the treatment phases, follow-up assessments will be conducted to monitor your health and any long-term effects of the treatment.

    The trial is expected to continue until March 2028, with regular check-ins to ensure your well-being and gather data on the treatment's effectiveness.

Who can join the trial?

11 criteria

  • Have a new diagnosis of small cell lung cancer confirmed by a test called histology or cytology, which examines cells from the lungs.
  • Male participants must agree to avoid donating sperm and either abstain from heterosexual intercourse or use contraception during the study and for a specified time after the last dose of medication.
  • Female participants must not be pregnant or breastfeeding and must use a highly effective form of birth control or abstain from heterosexual intercourse during the study and for a specified time after the last dose of medication. They must also have a negative pregnancy test before starting the study.
  • Agree to participate in the study by signing a written consent form.
  • Have organs that are working well enough to participate in the study.
  • Have extensive-stage small cell lung cancer, which is a specific stage of the disease.
  • Have at least one tumor that can be measured according to specific criteria used by doctors.
  • Provide a sample of tumor tissue for testing, either from a previous biopsy or a new one.
  • Be at least 18 years old at the time of signing the consent form.
  • Have a life expectancy of at least 3 months from the start of the study.
  • Have a performance status of 0 to 1, which means being fully active or having some symptoms but still able to carry out light work, as assessed within 7 days before the first dose of the study medication.

Who cannot join the trial?

8 criteria

  • Patients who have received previous treatment for their lung cancer.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have allergies to the study medications.
  • Patients with a history of other cancers, unless they have been in remission for a certain period.
  • Patients with active infections that require treatment.
  • Patients with certain heart conditions that could be worsened by the study medications.
  • Patients who are unable to follow the study procedures or attend study visits.
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Investigated drugs

  • Pembrolizumab

    is a medication that helps the immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better detect and attack these cells.

  • Lenvatinib

    is a medication that helps stop the growth of cancer cells by blocking certain proteins that cancer cells need to grow. It is used in combination with other treatments to enhance their effectiveness.

  • Carboplatin

    is a type of chemotherapy that works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is used to treat various types of cancer, including lung cancer.

  • Etoposide

    is another chemotherapy drug that works by interfering with the DNA of cancer cells, stopping them from multiplying. It is often used in combination with other chemotherapy drugs to treat lung cancer.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered intravenously and is currently being studied in combination with other drugs for treating extensive-stage small cell lung cancer. It is an approved immunotherapy drug that works by blocking a specific protein on cancer cells, allowing the immune system to better attack the cancer. Pembrolizumab is classified as a monoclonal antibody and is widely recognized in medical literature for its role in cancer treatment.

  • Lenvatinib

    This medication is taken orally and is being evaluated in combination with other treatments for extensive-stage small cell lung cancer. It is an approved drug that inhibits certain proteins involved in cancer cell growth and blood vessel formation, thereby slowing tumor progression. Lenvatinib is classified as a tyrosine kinase inhibitor and is well-documented in medical literature for its effectiveness in various cancers.

Investigated diseases

Extensive-Stage Small Cell Lung Cancer (ES-SCLC) – 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 lungs to other parts of the body. The disease often progresses rapidly, affecting the respiratory system and potentially 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 of ES-SCLC can vary, but it typically involves a rapid spread to distant organs.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511412-25-00Estimated enrolment46 patientsSponsorFundacion GECP

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).