Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Pembrolizumab with Chemotherapy for Patients with Resectable Stage II, IIIA, and IIIB Non-Small Cell Lung Cancer

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Non-small Cell Lung Cancer (NSCLC), specifically in stages II, IIIA, and certain cases of stage IIIB. The study is investigating the effects of a treatment called Pembrolizumab, also known by its code name MK-3475, which is used in combination with chemotherapy drugs. The chemotherapy drugs involved in this study include Cisplatin, Gemcitabine, and Pemetrexed. These treatments are given to patients who have a type of lung cancer that can be surgically removed.

The purpose of the study is to see how well these treatments work when given before and after surgery. Some participants will receive the combination of chemotherapy and Pembrolizumab, while others will receive chemotherapy with a placebo. The study will monitor participants over a period of time to assess their recovery and overall health outcomes.

Participants will receive the treatments through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will track important outcomes such as how long participants live without the cancer returning and their overall survival. Additionally, the study will look at the response of the cancer to the treatment and any side effects experienced by the participants. The trial aims to provide valuable information on the effectiveness of adding Pembrolizumab to standard chemotherapy for treating this type of 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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including having a resectable stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC).

    A performance status assessment is conducted to ensure the ability to participate in the trial.

  2. Step 2

    Initial treatment phase

    The initial treatment involves receiving a combination of chemotherapy drugs and possibly pembrolizumab, depending on the group assignment.

    Chemotherapy drugs include cisplatin, gemcitabine, and pemetrexed, administered through intravenous infusion.

    Pembrolizumab, if administered, is given as a 25 mg/mL solution for infusion.

  3. Step 3

    Surgery

    Following the initial treatment phase, surgery is performed to remove the tumor.

    The timing of the surgery is determined based on the response to the initial treatment.

  4. Step 4

    Post-surgery treatment

    After surgery, additional treatment may be administered, which could include further chemotherapy and pembrolizumab infusions.

    The purpose of this phase is to eliminate any remaining cancer cells and reduce the risk of recurrence.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up visits are scheduled to monitor health status and assess the effectiveness of the treatment.

    Imaging tests and other assessments are conducted to evaluate event-free survival and overall survival.

Who can join the trial?

7 criteria

  • Have previously untreated and pathologically confirmed **resectable Stage II, IIIA, or IIIB (N2) NSCLC**. This means the lung cancer is at a stage where it can be surgically removed and has not been treated before.
  • If male, must agree to use **contraception** or practice **abstinence** and refrain from donating sperm during the treatment period and for a certain time after the last dose of the study treatment.
  • If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply:
    • Not a **woman of childbearing potential (WOCBP)**, meaning she cannot become pregnant.
    • A WOCBP who agrees to follow contraceptive guidance during the treatment period and for a certain time after the last dose of the study treatment. She also agrees not to donate eggs or freeze/store them for future use during this period.
    • Have available **formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks** for submission. If blocks are not available, have unstained slides for submission for central **programmed death-ligand 1 (PD-L1) testing**. This involves providing a sample of the tumor for testing.
    • Have an **Eastern Cooperative Oncology Group (ECOG) performance status** of 0 to 1 within 10 days of randomization. This is a scale used to assess how well a patient can perform daily activities.
    • Have **adequate organ function**, meaning the organs are working well enough to participate in the study.

Who cannot join the trial?

10 criteria

  • Participants who have had any other type of cancer in the past, except for certain skin cancers that have been treated.
  • Participants who have serious heart problems, such as heart failure or a recent heart attack.
  • Participants who have uncontrolled high blood pressure.
  • Participants who have an active infection that requires treatment with antibiotics.
  • Participants who are pregnant or breastfeeding.
  • Participants who have a known allergy to the study medication or its ingredients.
  • Participants who have a history of certain lung diseases, such as interstitial lung disease, which affects the tissue and space around the air sacs of the lungs.
  • Participants who have received another investigational drug within a certain period before the study.
  • Participants who have had major surgery within a certain period before the study.
  • Participants who have a history of drug or alcohol abuse that could interfere with the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Pembrolizumab (MK-3475)

    is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is often used in treating various types of cancer, including non-small cell lung cancer (NSCLC), by blocking a specific protein that prevents the immune system from effectively targeting cancer cells.

  • Platinum Doublet Chemotherapy

    is a combination of two chemotherapy drugs that contain platinum. This therapy is commonly used to treat non-small cell lung cancer (NSCLC). The platinum-based drugs work by damaging the DNA of cancer cells, which stops them from growing and dividing. This type of chemotherapy is often used to shrink tumors before surgery or to eliminate any remaining cancer cells after surgery.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered intravenously and is currently being studied in clinical trials as a treatment for resectable Stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC). It is an approved medication in the field of oncology and is well-documented in medical literature. The main therapeutic indication for pembrolizumab in this trial is as a neoadjuvant or adjuvant therapy in combination with platinum doublet chemotherapy. 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.

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 tissues of the lung. NSCLC is often diagnosed at an advanced stage, as early symptoms can be mild or mistaken for other conditions. The disease progresses as cancer cells grow and potentially spread to other parts of the body, including lymph nodes and distant organs. Treatment often involves a combination of surgery, chemotherapy, and radiation, depending on the stage and specific characteristics of the cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504820-24-00Protocol codeMK-3475-671Estimated enrolment774 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.