Not recruiting

Study of Pembrolizumab, Pemetrexed, and Carboplatin for Patients with Advanced Stage Non-Small Cell Lung Cancer (NSCLC)

Verified siteRegistered drugNo placebo

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 treatments for advanced stage non-small cell lung cancer (NSCLC). The study is investigating the effects of a medication called pembrolizumab, which is also known by its brand name Keytruda, when used alone or in combination with chemotherapy. The chemotherapy drugs being studied alongside pembrolizumab include pemetrexed, carboplatin, and paclitaxel. These medications are given as solutions through a vein, a method known as intravenous infusion.

The purpose of the study is to understand how well pembrolizumab, both alone and with chemotherapy, works in treating patients with NSCLC who have high levels of a protein called PD-L1 and a high number of cancer cells in their body. Participants in the study will receive either pembrolizumab by itself or pembrolizumab with one or more of the chemotherapy drugs. The study will monitor the response of the cancer to these treatments over a period of time, looking at how the cancer shrinks or stabilizes.

Throughout the study, participants will receive regular assessments to track the progress of their cancer and any side effects they may experience. The study aims to provide valuable information on the effectiveness and safety of these treatment combinations for patients with advanced NSCLC. The results will help determine the best approach to using pembrolizumab and chemotherapy together in treating this type of lung cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient must provide written consent to participate.
Eligibility criteria include being 18 years or older, having a confirmed diagnosis of advanced stage non-small cell lung cancer (NSCLC), and meeting specific health requirements.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes providing a tissue sample from a tumor biopsy and ensuring adequate organ function.
Step 3
Treatment phase
The treatment involves the administration of medications through an intravenous route. The medications include pembrolizumab, pemetrexed, carboplatin, and paclitaxel.
The specific dosage and frequency of each medication will be determined by the study protocol and the patient's health status.
Step 4
Monitoring and evaluation
The patient's response to the treatment will be monitored regularly. This includes assessing the overall response rate (ORR) and disease control rate (DCR) at week 6.
Additional evaluations will include progression-free survival (PFS) and overall survival (OS).
Step 5
Safety assessment
The safety of the treatment will be assessed by monitoring any adverse events experienced by the patient. These events will be evaluated according to established criteria.
Step 6
Completion of the trial
The trial is expected to conclude by December 31, 2025. The patient's participation will end upon completion of the study or if they choose to withdraw.

Who can join the trial?

9 criteria

Have a confirmed diagnosis of **NSCLC** (a type of lung cancer) that is advanced, and does not have specific genetic changes called **EGFR mutations** or **ALK fusions**. If the cancer is of a type called **squamous NSCLC**, no genetic testing is needed.
Have an **ECOG Performance Scale** score of 0-2, which is a way to measure how well you can perform daily activities.
Be willing and able to sign a document called **informed consent**, which shows you understand the trial and agree to participate.
Be at least 18 years old on the day you sign the informed consent.
Have a disease that can be measured using a method called **RECIST v1.1**, which helps doctors track the size of tumors.
Provide a sample of tissue from a tumor biopsy that has not been treated with radiation.
Have a high level of a protein called **PD-L1** in the tumor, with a **TPS** (Tumor Proportion Score) of 50% or more.
Have a high tumor burden, meaning the cancer has spread to other parts of the body (**metastases**) and cannot be treated with local therapies.
Have adequate blood and organ function, meaning your body is healthy enough to handle the treatment.

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

Amsterdam UMC
Responsive
Amsterdam, The Netherlands
Stichting OLVG
Verified
Amsterdam, The Netherlands

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
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, allowing the immune system to better recognize and attack these cells. This medication is being tested alone and in combination with chemotherapy to see how effective it is in treating patients with non-small cell lung cancer (NSCLC) who have high levels of a protein called PD-L1 and a high tumor burden.
Chemotherapy
is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is being used alongside pembrolizumab to determine if the combination is more effective than pembrolizumab alone in improving the overall response rate in patients with NSCLC. Chemotherapy works by targeting rapidly dividing cells, which include cancer cells, to stop their growth and spread.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently well-established in medical literature as an immunotherapy treatment for various cancers, including non-small cell lung cancer (NSCLC). The main therapeutic indication for pembrolizumab in this context is advanced stage NSCLC, particularly in patients with high PD-L1 expression and high tumor burden. At the molecular level, pembrolizumab works by blocking the PD-1 receptor on T-cells, preventing cancer cells from evading the immune response. It is classified as a monoclonal antibody and functions 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 and squamous cell carcinoma. It is the most common form of lung cancer, accounting for about 85% of cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. In advanced stages, the cancer may have spread beyond the lungs to other parts of the body. Symptoms can include a persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some tumors growing rapidly while others remain stable for a period of time.