Study Comparing SB27 and Pembrolizumab for Patients with Metastatic Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as non-small cell lung cancer (NSCLC), specifically the metastatic non-squamous subtype. The study aims to compare the effectiveness and safety of two medications: SB27, a proposed biosimilar of pembrolizumab, and Keytruda, which is an existing treatment for this type of cancer. Both medications are given as a solution for infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to determine if SB27 works as well as Keytruda in treating patients with this type of lung cancer. Participants in the study will receive either SB27 or Keytruda, and some may receive a placebo. The study will monitor how well the cancer responds to the treatment, as well as any side effects that may occur. The trial will take place over a period of time, with regular check-ups and assessments to track the progress of the treatment.

In addition to SB27 and Keytruda, the study may also involve other medications such as carboplatin and pemetrexed, which are commonly used in cancer treatment. These medications are also given as infusions. The study is designed to ensure that all participants receive the best possible care while contributing to important research that could improve future treatments for non-small cell lung cancer.

1 joining the study

Upon joining the study, you will be informed about the trial’s purpose, procedures, and your role as a participant. You will be asked to provide informed consent, which means you agree to participate after understanding all the details.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are at least 18 years old, have been diagnosed with stage IV non-squamous non-small cell lung cancer, and have not received prior systemic anti-cancer therapy for this condition.

3 treatment phase

During the treatment phase, you will receive medications through intravenous administration. This means the medication will be given directly into your vein.

You will receive pembrolizumab or its biosimilar SB27, carboplatin, and pemetrexed. The specific dosage and frequency will be explained to you by the medical team.

The treatment will continue for a specified duration, which will be communicated to you during the trial.

4 regular monitoring

Throughout the trial, you will undergo regular monitoring to assess your response to the treatment. This includes physical examinations, imaging tests, and laboratory tests.

The objective is to evaluate the objective response rate (ORR), which measures how well the cancer responds to the treatment.

5 follow-up visits

After completing the treatment phase, you will have follow-up visits to monitor your health and any long-term effects of the treatment.

These visits are important to ensure your well-being and to gather additional data for the study.

Who Can Join the Study?

Must be a male or female who is 18 years of age or older.
Must have been diagnosed with stage IV non-squamous non-small cell lung cancer (NSCLC). This means the cancer has spread to other parts of the body and is a specific type of lung cancer.
Must not have received any prior systemic anti-cancer therapy for metastatic NSCLC. This means you have not had treatments like chemotherapy that affect the whole body for this type of cancer.
Must agree to use adequate methods of contraception. This means using reliable birth control methods to prevent pregnancy during the study.

Who Cannot Join the Study?

Patients with other types of cancer besides non-small cell lung cancer cannot participate.
Patients who have received treatment with a drug similar to Keytruda in the past may not be eligible.
Patients with severe or uncontrolled medical conditions that could interfere with the study results are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to similar medications are not eligible.
Patients who are unable to comply with the study procedures and follow-up visits are excluded.
Patients with active infections that require treatment are not eligible.
Patients with a history of drug or alcohol abuse that could interfere with the study are excluded.
Patients who have participated in another clinical trial within the last 30 days are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Medisprof S.R.L.	Cluj Napoca	Romania

Other Sites

Site Name	City	Country
Onco Clinic Consult S.A.	Craiova	Romania
Sigmedical Services S.R.L.	Suceava	Romania
Centrul De Oncologie-Euroclinic S.R.L.	Iasi	Romania
Oncolab S.R.L.	Craiova	Romania
Martha-Maria Krankenhaus Halle-Doelau gGmbH	Halle (Saale)	Germany
Pelican Impex S.R.L.	Oradea	Romania
Hospital Quironsalud Malaga	Malaga	Spain
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Kaiserswerther Diakonie	Duesseldorf	Germany
Spitalul Clinic Judetean De Urgenta Sibiu	Sibiu	Romania
Sggmxcqp Kpyosjscsfe Bceufylci Fdpi Die Gxylkuqwcm Muzpj	Moers	Germany
Mju fvet Hffpdgkdugut uwv Ocqnidusq Rwlmjbycexd Gxit	Neuss	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	19.02.2024
Romania	Not recruiting	19.02.2024
Spain	Not recruiting	19.02.2024

Trial locations

Investigated drugs:

SB27 is a medication being tested in this clinical trial. It is a proposed biosimilar to another medication called Keytruda. A biosimilar is a type of medication that is very similar to an already approved drug, in this case, Keytruda. The purpose of SB27 in this trial is to see if it works just as well as Keytruda in treating a type of lung cancer known as metastatic non-squamous non-small cell lung cancer. Researchers are looking at how effective SB27 is, how safe it is for patients, how the body processes it, and whether it causes any immune reactions.

Keytruda is a medication that is already approved and used to treat various types of cancer, including metastatic non-squamous non-small cell lung cancer. It works by helping the immune system recognize and attack cancer cells. In this trial, Keytruda is being used as a comparison to see if the new medication, SB27, is just as effective and safe for patients. The study aims to compare the two medications to ensure that SB27 can be a reliable alternative for patients with this type of lung cancer.

Investigated diseases:

Non-small cell lung cancer

Non-small Cell Lung Cancer – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It generally starts in the tissues of the lungs and can spread to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with normal lung function. Over time, these tumors may invade nearby tissues and organs. As the cancer advances, it can metastasize, meaning it spreads to distant parts of the body through the bloodstream or lymphatic system. The progression of non-small cell lung cancer can vary depending on the subtype and individual patient factors.

Trial ID:

2023-507448-36-00

Protocol code:

SB27-3004

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing SB27 and Pembrolizumab for Patients with Metastatic Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?