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Study of Pembrolizumab, Vibostolimab, and Chemotherapy for Patients with Newly Diagnosed Resectable Stage II-IIIB Non-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 non-small cell lung cancer (NSCLC), specifically in patients who have been newly diagnosed with stages II to IIIB (N2) of the disease. The study will explore the effects of different investigational agents, which are new treatments being tested, in combination with pembrolizumab, a medication that helps the immune system fight cancer, and various chemotherapy drugs. The chemotherapy drugs involved in this study include gemcitabine hydrochloride, cisplatin, pemetrexed, paclitaxel, and carboplatin. Additionally, the study will use a placebo in some cases to compare the effects of the investigational treatments.

The purpose of the study is to estimate the incidence of a complete response in the resected primary tumor and lymph nodes after treatment. This means the study aims to see how often the cancer is completely removed or destroyed by the treatment. Participants will receive the treatments through an intravenous infusion, which is a way of delivering medication directly into the bloodstream. The study will be conducted over a period of up to 12 months, during which participants will receive the investigational treatments and undergo regular assessments to monitor their response to the therapy.

Throughout the study, researchers will also evaluate the extent of any remaining cancer in the resected lung tumor and lymph node sections. This will help determine how effective the treatments are in reducing the size and spread of the cancer. The study will also monitor for any adverse events, which are unwanted side effects, and assess the overall survival and event-free survival of participants. This information will contribute to understanding the potential benefits and risks of the investigational treatments for patients with non-small cell lung cancer.

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 verifying the diagnosis of resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC).

    A performance status evaluation is performed to ensure the ability to undergo the study protocol, including surgery.

  2. Step 2

    Treatment phase

    The treatment phase involves the administration of investigational agents and chemotherapy. The specific medications used include pembrolizumab, vibostolimab, gemcitabine hydrochloride, cisplatin, sacituzumab tirumotecan, paclitaxel, and carboplatin.

    These medications are administered through intravenous infusion at specified intervals. The exact dosage and frequency depend on the specific treatment arm assigned.

  3. Step 3

    Surgical intervention

    Following the treatment phase, a surgical procedure is performed to remove the primary lung tumor and affected lymph nodes.

    The goal is to achieve a pathological complete response (pCR), which means no residual cancer is detected in the resected tissue.

  4. Step 4

    Post-surgery evaluation

    After surgery, the extent of any remaining viable tumor is assessed. This is measured as the percent residual viable tumor (%RVT).

    Additional evaluations include monitoring for any adverse events and assessing recovery progress.

  5. Step 5

    Follow-up period

    The follow-up period involves regular check-ups to monitor overall health and detect any signs of cancer recurrence.

    Key outcomes measured during this period include event-free survival (EFS), overall survival (OS), and distant metastasis-free survival (DMFS).

Who can join the trial?

8 criteria

  • The patient must have a type of lung cancer called non-small cell lung cancer (NSCLC) that is newly diagnosed and can be surgically removed. The cancer should be at Stage II, IIIA, or IIIB (N2).
  • The patient should not have received any treatment for this lung cancer before.
  • The patient must be able to undergo the planned treatment, which includes surgery.
  • The patient should not need a specific treatment called epidermal growth factor receptor (EGFR)-directed therapy as their main treatment. This is a type of treatment that targets certain proteins in cancer cells.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • The patient must be able to provide a sample of the lung tumor or lymph node, either from a previous biopsy or a new one. A biopsy is a small sample of tissue taken for testing.
  • Both male and female patients can participate.
  • The study does not include vulnerable populations, which means it is not designed for groups that might need special protection.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a specific protein on cancer cells, making it easier for the immune system to attack and destroy them. This medication is often used in combination with other treatments to improve its effectiveness.

  • Chemotherapy

    involves the use of drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is combined with other investigational agents and pembrolizumab to treat non-small cell lung cancer. The goal is to reduce the size of the tumor and eliminate cancer cells before surgery.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered intravenously, typically as an infusion over a set period. It is currently a well-established medication in the field of oncology, with extensive documentation in medical literature. The primary therapeutic indication for pembrolizumab is the treatment of various types of cancer, including non-small cell lung cancer (NSCLC). At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Non-small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. NSCLC is often diagnosed at an advanced stage, as early symptoms can be mild or mistaken for other conditions. The disease progresses as the cancer cells multiply and can spread to other parts of the body, including lymph nodes and distant organs. Stages II-IIIB indicate that the cancer has spread to nearby lymph nodes or structures but not to distant sites. Resectable NSCLC means that the tumor can potentially be removed through surgery, which is a key consideration in treatment planning.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509234-19-00Protocol codeMK-3475-01EEstimated enrolment75 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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