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Study on the Effectiveness and Safety of Pembrolizumab, Quavonlimab, and Lenvatinib for Patients with Advanced Small Cell Lung Cancer Needing Second-Line Treatment

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 people with extensive-stage small cell lung cancer (ES-SCLC) who need a second-line therapy. The study involves the use of several investigational treatments, including Pembrolizumab, which is a type of medication known as an immune checkpoint inhibitor. Pembrolizumab is being tested in combination with other investigational agents such as Quavonlimab, Favezelimab, MK-4830, and Lenvatinib. These treatments are designed to help the immune system fight cancer cells more effectively.

The purpose of this study is to evaluate the safety and effectiveness of these treatment combinations. Participants will receive these medications either through an intravenous infusion, which means the medicine is given directly into a vein, or orally, in the form of capsules. The study will monitor participants for any side effects and measure how well the cancer responds to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the investigational treatments.

Throughout the study, participants will have regular check-ups and assessments to track their health and the progress of their cancer. The study aims to provide valuable information on how these new treatment combinations can help people with ES-SCLC who have not responded to initial treatments. The trial is expected to continue until 2026, allowing researchers to gather comprehensive data on the long-term effects and benefits of these therapies.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A tumor tissue sample is required, either from previous records or a new biopsy, to confirm the diagnosis of extensive-stage small cell lung cancer.

  2. Step 2

    Treatment allocation

    Participants are assigned to receive a combination of investigational treatments. The specific combination depends on the study group assigned.

    The treatments include pembrolizumab, quavonlimab, lenvatinib, favezelimab, and MK-4830.

  3. Step 3

    Treatment administration

    Pembrolizumab and quavonlimab are administered via intravenous infusion. The frequency and dosage are determined by the study protocol.

    Lenvatinib is taken orally in capsule form. The dosage and frequency are specified by the study protocol.

    Favezelimab and MK-4830 are also administered via intravenous infusion, with specific dosage and frequency outlined in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes physical exams, blood tests, and imaging studies.

    Participants are evaluated for any adverse effects and the response to treatment is measured using established criteria.

  5. Step 5

    Completion of treatment

    The treatment phase continues until the study's end date or until the participant experiences unacceptable side effects or disease progression.

    Upon completion, a final assessment is conducted to evaluate the overall response to the treatment.

Who can join the trial?

15 criteria

  • The participant must have a confirmed diagnosis of **extensive-stage small cell lung cancer (ES-SCLC)** and need second-line therapy. This means the cancer has spread widely and the patient needs another treatment after the first one.
  • The participant must provide a sample of their tumor tissue, either from a previous sample or a new biopsy, which is a small piece of the tumor taken for testing.
  • The participant must have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 to 1. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to do light work.
  • If the participant has **Hepatitis B**, they must have been treated for at least 4 weeks and have no detectable virus in their blood before starting the study.
  • If the participant has a history of **Hepatitis C**, the virus must not be detectable in their blood at the start of the study.
  • The participant's blood pressure must be well-controlled, meaning it should be 150/90 mm Hg or lower, with or without medication, and no changes in medication within a week before starting the study.
  • The participant must have a life expectancy of more than 3 months.
  • The participant must have had their cancer progress after treatment with a specific type of medication called **anti-PD-1/PD-L1 monoclonal antibody**, which was part of their first treatment.
  • The participant's cancer must be classified as **Stage IV** according to a specific cancer staging system, meaning it has spread to other parts of the body.
  • The participant must have received one previous treatment for small cell lung cancer.
  • Male participants must either not engage in heterosexual intercourse or agree to use contraception during treatment and for at least 7 days after the last dose of a specific medication called lenvatinib. No contraception is needed if they are receiving other specified medications.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must not engage in heterosexual intercourse or use contraception during the study and for a specified time after the last dose of certain medications.
  • Female participants must not breastfeed during the study and for a specified time after the last dose of certain medications.
  • Women who can have children must have a negative pregnancy test within 24 hours before the first dose of the study treatment.
  • The participant must have measurable disease according to specific criteria, meaning the cancer can be measured and tracked during the study.

Who cannot join the trial?

4 criteria

  • Participants who do not have extensive-stage small cell lung cancer. This means the cancer has spread widely in the body.
  • Participants who are not within the specified age range for the study.
  • Participants who are not male or female, as the study includes both genders.
  • Participants who belong to a vulnerable population, which means groups that might need special protection or care.
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Investigated drugs

Pembrolizumab is a medication used in this trial to help the immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. This medication is being tested in combination with other investigational agents to see if it can improve outcomes for patients with a specific type of lung cancer that has not responded to previous treatments.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in combination with other investigational agents for treating patients with extensive-stage small cell lung cancer who have not responded to PD-1/L1 inhibitors. The main therapeutic indication for pembrolizumab is to enhance the immune system's ability to detect and fight cancer cells. At the molecular level, it works by blocking the PD-1 pathway, which cancer cells use to evade the immune system. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Extensive-stage small cell lung cancer – This is a type of lung cancer characterized by the rapid growth and spread of cancer cells originating in the lung tissues. It is termed "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, requiring prompt medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-507687-38-00Protocol codeMK-3475-B98Estimated enrolment120 patientsSponsorMerck Sharp & Dohme LLC

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