Study Comparing the Effects and Safety of FYB206 and Pembrolizumab with Chemotherapy in Patients with Metastatic Non-Squamous 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 metastatic non-squamous non-small cell lung cancer (NSCLC). The trial aims to compare the effects, safety, and immune response of a new treatment called FYB206, which is a biosimilar candidate to an existing medication known as Keytruda (also called pembrolizumab). Both treatments are used in combination with chemotherapy for patients who have not received prior treatment for this type of cancer.

The purpose of the study is to demonstrate that FYB206 is as effective as Keytruda when used alongside chemotherapy. Participants in the study will receive either FYB206 or Keytruda through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to 24 months, during which the participants’ health will be closely monitored. This includes checking how well the cancer responds to the treatment, whether it shrinks or disappears, and observing any side effects or changes in health indicators like vital signs and laboratory test results.

Throughout the study, researchers will also assess the participants’ immune response to the treatments by measuring the presence of antibodies. Antibodies are proteins that the body produces to fight off foreign substances, and sometimes they can form against medications. The study will also track the levels of the drug in the participants’ blood at various times to ensure the treatment is being administered effectively. The trial is expected to continue until the end of 2027.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of Stage IV non-squamous non-small cell lung cancer (NSCLC) and no prior systemic treatment for metastatic NSCLC.

A performance status assessment is conducted to ensure the ability to perform daily activities, rated as 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.

2 treatment initiation

The treatment involves the administration of pembrolizumab or its biosimilar candidate FYB206 as an add-on to chemotherapy.

The medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

3 treatment schedule

The treatment is administered at regular intervals, with the specific schedule determined by the study protocol.

The primary goal is to assess the effectiveness of the treatment over approximately 9 months (40 weeks).

4 monitoring and assessments

Regular monitoring includes checking for side effects, vital signs, oxygen levels, and laboratory test results.

The presence of antibodies against the treatments is assessed at specific timepoints to understand the body’s immune response.

5 evaluation of treatment response

The primary endpoint is measured by the proportion of participants whose cancer resolves completely or partially after approximately 9 months.

Secondary endpoints include the time to cancer resolution, duration without disease progression, and overall survival after one year.

6 study completion

The study is expected to conclude by December 31, 2027, with ongoing assessments to evaluate long-term outcomes and safety.

Who Can Join the Study?

Patients must have a confirmed diagnosis of Stage IV non-squamous NSCLC. NSCLC stands for non-small cell lung cancer, which is a type of lung cancer.
Patients should not have received any prior systemic treatment for metastatic non-squamous NSCLC. However, if they had treatment before the cancer spread (called adjuvant or neoadjuvant therapy), they can still participate if this treatment was finished at least 12 months before the cancer became metastatic.
Patients need to have an ECOG performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
Patients must confirm that EGFR or ALK-directed therapy is not needed. This means they should not have certain genetic changes in their cancer that would require specific treatments. If they don’t have test results for these genetic changes, tests will be done during the screening process.
Both male and female patients are eligible to participate.
Patients from vulnerable populations can also participate.

Who Cannot Join the Study?

Patients who have a different type of cancer than NSCLC (Non-Small Cell Lung Cancer) cannot participate.
Patients who are not receiving chemotherapy as part of their treatment plan cannot participate.
Patients who are not considered part of the vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those with certain disabilities.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
Patients who are not able to follow the study procedures or attend required visits cannot participate.
Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.

Where you can join this trial?

Verified and Recommended Sites

Site Name	City	Country	Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie	Lublin	Poland

Verified Sites

Site Name	City	Country	Status
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
Medisprof S.R.L.	Cluj Napoca	Romania

Other Sites

Site Name	City	Country
University Multiprofile Hospital For Active Treatment Sofiamed OOD	Sofia	Bulgaria
Radiotherapy Center Cluj S.R.L.	Floresti	Romania
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.	Slupsk	Poland
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Oncomed S.R.L.	Timisoara	Romania
Spitalul De Oncologie Monza S.R.L.	Bucharest	Romania
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy	Otwock	Poland
Gcct Mgrxrbp Stbzob	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	30.06.2024
Poland	Not recruiting	30.06.2024
Romania	Not recruiting	30.06.2024

Trial locations

Investigated drugs:

Pembrolizumab

FYB206 is a biosimilar candidate to Keytruda. It is being tested to see if it works as well as Keytruda when used together with chemotherapy in patients who have not been treated before and have a type of lung cancer called metastatic non-squamous non-small cell lung cancer.

Keytruda is a medication used to treat certain types of cancer by helping the immune system fight cancer cells. In this trial, it is used in combination with chemotherapy to treat patients with metastatic non-squamous non-small cell lung cancer. The trial aims to compare its effectiveness and safety with FYB206.

Investigated diseases:

Non-small cell lung cancer metastatic

Non-Small Cell Lung Cancer (NSCLC) – This is the most common type of lung cancer, accounting for about 85% of all lung cancer cases. It typically starts in the epithelial cells lining the lungs and can spread to other parts of the body if not managed. NSCLC progresses through stages, beginning with localized tumors and potentially advancing to more widespread disease. The progression is often categorized by tumor size, lymph node involvement, and the presence of metastasis. Symptoms may include persistent cough, chest pain, and difficulty breathing, which can worsen as the disease advances. Early detection is crucial for managing the progression of NSCLC.

Trial ID:

2023-509766-37-00

Protocol code:

FYB206-C3-02

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing the Effects and Safety of FYB206 and Pembrolizumab with Chemotherapy in Patients with Metastatic Non-Squamous Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?