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

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What is this study about?

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.

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.

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.

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.

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).

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.

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 Study?

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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Stichting OLVG	Amsterdam	The Netherlands

Other Sites

Site Name	City	Country
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Tergooiziekenhuizen	Hilversum	The Netherlands
Flevoziekenhuis Stichting	Almere	The Netherlands
Zaans Medisch Centrum Stichting	Zaandam	The Netherlands
Dijklander Ziekenhuis	Hoorn	The Netherlands
Anxqufktx Urq	Amsterdam	The Netherlands
Sxqnzidvj Byohjkf	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.01.2020

Trial locations

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.

Investigated diseases:

Non-small cell lung cancer

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.

Trial ID:

2024-516581-11-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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