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Study of MK-7684A with Chemoradiotherapy Compared to Chemoradiotherapy with Durvalumab for Patients with Stage III 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 for patients with Stage III cancer that cannot be surgically removed. The study will compare two different treatment approaches. One group of participants will receive a combination of MK-7684A (a coformulation of vibostolimab and pembrolizumab) along with radiation and chemotherapy. The other group will receive radiation and chemotherapy followed by durvalumab. The purpose of the study is to evaluate the effectiveness of these treatments in improving progression-free survival and overall survival.

Participants in the study will undergo a series of treatments over a period of time. The treatments will be administered through intravenous infusion, which means the medication is given directly into a vein. The study will involve regular monitoring and assessments to track the progress of the disease and the response to the treatment. This will help researchers understand how well the treatments work and their impact on the participants' health and quality of life.

The study aims to provide valuable insights into the treatment of non-small cell lung cancer and potentially improve outcomes for patients with this condition. By comparing the two treatment approaches, researchers hope to determine which method is more effective in managing the disease and extending the lives of those affected by it. Participants will be closely monitored throughout the study to ensure their safety and well-being.

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 the diagnosis of non-small cell lung cancer (NSCLC) at stage IIIA, IIIB, or IIIC. This involves reviewing medical history and conducting necessary imaging tests to ensure there is no evidence of metastatic disease.

  2. Step 2

    Treatment phase 1: chemoradiotherapy

    The first phase of treatment involves a combination of chemotherapy and radiation therapy. Chemotherapy drugs such as etoposide, carboplatin, pemetrexed, paclitaxel, and cisplatin are administered through intravenous infusion. The specific drugs and dosages are determined based on individual patient needs and the treatment plan.

  3. Step 3

    Treatment phase 2: immunotherapy

    Following the completion of chemoradiotherapy, patients receive immunotherapy. This involves the administration of MK-7684A (a combination of vibostolimab and pembrolizumab) or durvalumab through intravenous infusion. The choice of immunotherapy is based on the study group assignment.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring is conducted to assess the response to treatment and any side effects. This includes imaging tests and clinical evaluations. The primary focus is on progression-free survival and overall survival, as well as monitoring for any adverse events.

  5. Step 5

    Completion and evaluation

    Upon completion of the treatment phases, a final evaluation is conducted to assess the overall response to the treatment. This includes a review of all clinical data collected during the trial period.

Who can join the trial?

10 criteria

  • The patient must have a confirmed diagnosis of **non-small cell lung cancer (NSCLC)**. This means the type of lung cancer has been identified through tests.
  • The cancer must be at **Stage IIIA, IIIB, or IIIC** according to a specific cancer staging system. This describes how much the cancer has spread.
  • The cancer must be **unresectable**, meaning it cannot be removed with surgery, as determined by a team of doctors or a lung specialist.
  • There must be no signs of the cancer spreading to other parts of the body, known as **metastatic disease**, based on specific body scans.
  • The patient must have a **measurable disease**, meaning there is at least one tumor that can be measured to track changes during the study.
  • The patient must not have received any previous treatments like chemotherapy, targeted therapy, or radiotherapy for their Stage III NSCLC.
  • The patient must provide a **tumor tissue sample** from a biopsy, which is a small piece of the tumor taken for testing.
  • The patient must have an **ECOG Performance Status** of 0 or 1, which is a scale used to assess how well a patient can perform daily activities.
  • The patient must have a **life expectancy** of at least 6 months, meaning they are expected to live for at least this amount of time.
  • Both male and female patients are eligible to participate.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides non-small cell lung cancer cannot participate. Non-small cell lung cancer is a type of lung cancer that grows and spreads more slowly than small cell lung cancer.
  • Patients who have not met the age requirements for the study cannot participate. The study may have specific age limits.
  • Patients who are not able to follow the study procedures or instructions cannot participate.
  • Patients who have certain medical conditions that could interfere with the study cannot participate. These conditions are not specified but could include other serious illnesses.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medication or similar medications cannot participate.
  • Patients who have a history of substance abuse or alcohol abuse may not be eligible.
  • Patients who have certain infections, like HIV or hepatitis, may not be eligible.
  • Patients who have had a recent major surgery may not be eligible.
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Investigated drugs

  • MK-7684A

    This is a combination medication that includes two components, Vibostolimab and Pembrolizumab. It is used in this trial to help the body's immune system fight cancer cells. Vibostolimab is an experimental drug that may help activate the immune system, while Pembrolizumab is a well-known medication that blocks a specific protein used by cancer cells to hide from the immune system. Together, they aim to enhance the body's ability to detect and destroy cancer cells.

  • Durvalumab

    This medication is used to help the immune system attack cancer cells. It works by blocking a protein that cancer cells use to avoid being attacked by the immune system. In this trial, Durvalumab is used after chemoradiotherapy to help prevent the cancer from coming back or growing.

What is already known about the treatment

Vibostolimab with Pembrolizumab – This medication is administered as an intravenous infusion and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer. It is a coformulation of two drugs, vibostolimab and pembrolizumab, and is being compared to other treatments in terms of progression-free survival and overall survival. The main therapeutic indication is for patients with unresectable, locally advanced, stage III non-small cell lung cancer. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system attack cancer cells, while vibostolimab is believed to enhance this effect. This combination falls under the pharmacological classification of immune checkpoint inhibitors.

Investigated diseases

Non-small cell lung cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms. The progression of the disease can vary depending on the subtype and stage at diagnosis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502752-31-00Protocol codeMK-7684A-006Estimated enrolment209 patientsSponsorMerck Sharp & Dohme LLC

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