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Study Comparing Pembrolizumab and Lenvatinib with Docetaxel for Patients with Metastatic Non-Small Cell Lung Cancer After Previous Treatments

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 metastatic non-small cell lung cancer (NSCLC). This is a condition where cancer cells have spread from the lungs to other parts of the body. The study is comparing the effects of two different treatments. One treatment combines two medications: pembrolizumab (also known by its code name MK-3475) and lenvatinib (code name MK-7902). The other treatment uses a medication called docetaxel. Pembrolizumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein, while lenvatinib is taken as a capsule by mouth. Docetaxel is also given as an infusion.

The purpose of the study is to compare how well these treatments work in helping patients live longer and in slowing down the progression of the cancer. Participants in the study will receive either the combination of pembrolizumab and lenvatinib or docetaxel. The study will monitor the participants over a period to see how the cancer responds to the treatments and to check for any side effects. The study aims to provide valuable information on which treatment might be more effective for patients who have already been treated with other therapies, including chemotherapy and immunotherapy.

Throughout the study, participants will undergo regular check-ups and tests to track their health and the status of their cancer. These tests may include imaging scans like MRI or CT scans, which help doctors see inside the body and assess the size and spread of the cancer. The study will also look at the quality of life of participants, considering factors like pain and physical functioning. This research is important for finding better ways to treat metastatic NSCLC and improve outcomes for patients with this challenging condition.

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

    Joining the study

    Upon joining the study, participants will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment option.

  2. Step 2

    Treatment with pembrolizumab and lenvatinib

    Participants in this group will receive a combination of two medications: pembrolizumab and lenvatinib.

    Pembrolizumab is administered as an intravenous infusion, which means it is given through a vein. The infusion is done once every three weeks.

    Lenvatinib is taken orally in the form of capsules. The dosage and frequency will be determined by the study team based on individual needs.

  3. Step 3

    Treatment with docetaxel

    Participants in this group will receive docetaxel, which is also administered as an intravenous infusion. The infusion is typically given once every three weeks.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, participants will undergo regular monitoring to assess their health and the effectiveness of the treatment. This includes physical exams, blood tests, and imaging tests such as CT or MRI scans.

    Participants will also be asked to complete questionnaires about their quality of life and any symptoms they may experience.

  5. Step 5

    End of treatment

    The treatment period will continue until the study ends, the disease progresses, or side effects become too severe. Participants will be informed about the next steps and any additional follow-up required.

Who can join the trial?

15 criteria

  • Has a confirmed diagnosis of **metastatic** squamous or nonsquamous **NSCLC** (Stage IV: M1a, M1b, M1c). **Metastatic** means the cancer has spread to other parts of the body. **NSCLC** stands for non-small cell lung cancer.
  • Has a life expectancy of at least 3 months.
  • Male participants must agree to either not have heterosexual intercourse or use contraception during the treatment and for a certain period after the last dose, depending on the medication received.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must agree to use contraception or not have heterosexual intercourse during the treatment and for a certain period after the last dose, depending on the medication received.
  • Has controlled blood pressure, defined as 150/90 mm Hg or lower, with or without medication, and no changes in blood pressure medication within 1 week before starting the study.
  • If the participant had major surgery or high-dose radiation therapy, they must have recovered from any side effects or complications.
  • Has adequate organ function, meaning the organs are working well enough to participate in the study.
  • Has **PD** (progressive disease) after treatment with one prior anti-PD-1/PD-L1 monoclonal antibody, which is a type of cancer treatment.
  • Has **PD** during or after platinum doublet chemotherapy for metastatic disease. **Chemotherapy** is a type of cancer treatment using drugs.
  • Has confirmation that certain targeted therapies (EGFR, ALK, or ROS1) are not suitable as primary treatment.
  • Has submitted imaging results showing evidence of **PD** after starting an anti-PD-1/PD-L1 inhibitor.
  • Has at least one measurable lesion (tumor) as seen on a CT or MRI scan, according to specific criteria.
  • Has provided a tumor tissue sample for PD-L1 biomarker analysis from a previous biopsy.
  • Has provided a new tissue sample from a biopsy done after completing immunotherapy and before starting the study.
  • Has an **ECOG performance status** of 0 or 1 within 7 days before the first dose of study treatment. This is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.

Who cannot join the trial?

5 criteria

  • Patients with a type of lung cancer called NSCLC (Non-Small Cell Lung Cancer) with either squamous or nonsquamous cell types cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Both male and female patients are considered for the study, but those who do not meet other criteria cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

  • Pembrolizumab

    is a type of cancer treatment known as immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is used to treat patients with a type of lung cancer called non-small cell lung cancer that has spread to other parts of the body and has not responded to previous treatments.

  • Lenvatinib

    is a medication that helps to stop the growth of cancer cells by blocking certain proteins that cancer cells need to grow. It is used in combination with pembrolizumab in this trial to treat patients with metastatic non-small cell lung cancer, aiming to improve the effectiveness of the treatment.

  • Docetaxel

    is a chemotherapy drug that works by interfering with the growth and spread of cancer cells. In this trial, it is used as a comparison treatment to evaluate the effectiveness of the combination of pembrolizumab and lenvatinib in patients with metastatic non-small cell lung cancer who have not responded to previous treatments.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently a well-established medication in the field of oncology, particularly in medical literature, for its role in treating various cancers. The main therapeutic indication for pembrolizumab in this trial is for patients with metastatic non-small cell lung cancer (NSCLC) who have already been treated with other therapies. At the molecular level, pembrolizumab works by blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

  • Lenvatinib

    Lenvatinib is taken orally in the form of a capsule, which means it is swallowed and absorbed through the digestive system. It is currently recognized in medical literature for its use in treating certain types of cancer, including thyroid cancer and renal cell carcinoma. In this trial, lenvatinib is used in combination with pembrolizumab for patients with metastatic non-small cell lung cancer (NSCLC). Lenvatinib works by blocking certain proteins that promote the growth of blood vessels in tumors, effectively starving the cancer cells. It is classified as a tyrosine kinase inhibitor, a type of medication that interferes with specific enzymes involved in cancer cell growth.

  • Docetaxel

    Docetaxel is administered as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. It is a well-known chemotherapy drug in medical literature, used for treating various types of cancer, including breast, prostate, and lung cancer. In this trial, docetaxel is used as a comparator for patients with metastatic non-small cell lung cancer (NSCLC) who have previously received other treatments. Docetaxel works by disrupting the normal function of microtubules in cells, which are structures that help cells divide, thereby preventing cancer cells from multiplying. It is classified as a taxane, a type of chemotherapy that targets rapidly dividing cells.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – Non-Small Cell Lung Cancer is a type of lung cancer that includes several subtypes, such as squamous cell carcinoma and adenocarcinoma. It typically begins in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with normal lung function. Over time, these tumors may invade nearby tissues and organs. As the cancer advances, it can metastasize, meaning it spreads to distant parts of the body through the bloodstream or lymphatic system. The progression of NSCLC can vary greatly among individuals, depending on factors like the cancer's subtype and stage at diagnosis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501439-18-00Protocol codeMK-7902-008Estimated enrolment492 patientsSponsorMerck Sharp & Dohme LLC

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