Study of Tislelizumab, LBL-007, and BGB-15025 in Patients with Advanced Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Non-Small Cell Lung Cancer, which is a type of lung cancer that can be locally advanced, meaning it has spread to nearby tissues, or metastatic, meaning it has spread to other parts of the body. The study will explore the effects of a medication called Tislelizumab, used in combination with other investigational agents, which are new treatments being tested, with or without chemotherapy. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells.

The purpose of the study is to assess how well Tislelizumab and the investigational agents work in treating patients with this type of lung cancer. Participants in the study will receive these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will also include a comparison with a placebo, which is a substance with no active medication, to help understand the effectiveness of the treatments being tested.

Throughout the study, participants will be monitored for their response to the treatment, including any changes in their cancer and any side effects they may experience. The study aims to provide valuable information on the potential benefits and risks of using Tislelizumab in combination with other investigational agents for treating Non-Small Cell Lung Cancer.

1 enrollment

Upon joining the study, you will be enrolled as a participant. This involves confirming your eligibility based on specific criteria, such as having a diagnosis of non-small cell lung cancer that is advanced or metastatic.

Your medical history and current health status will be reviewed to ensure you meet the study requirements.

2 initial assessment

An initial assessment will be conducted to establish a baseline for your health and the status of your cancer. This may include physical exams, blood tests, and imaging studies.

The assessment will help in evaluating your response to the treatment throughout the study.

3 treatment phase

You will receive the study treatment, which includes tislelizumab in combination with other investigational agents, with or without chemotherapy. The specific medications and their combinations will be determined by the study protocol.

The treatment is administered through intravenous infusion, which means the medication is given directly into your vein. The frequency and duration of the treatment will be specified by the study team.

4 regular monitoring

Throughout the study, you will undergo regular monitoring to assess your response to the treatment and to check for any side effects. This includes follow-up visits, blood tests, and imaging studies.

The study team will evaluate your progress and make any necessary adjustments to your treatment plan.

5 end of treatment

Once the treatment phase is completed, a final assessment will be conducted to evaluate the overall response to the treatment.

You will be informed about the results and any further steps or follow-up care that may be needed.

Who Can Join the Study?

Diagnosis of Non-small Cell Lung Cancer (NSCLC) that is either locally advanced, recurrent, or metastatic. This means the cancer has spread beyond the original site and cannot be treated with surgery or radiation alone.
No previous systemic treatment for metastatic NSCLC. However, if you had chemotherapy or radiation for earlier stages of the disease, it must have been completed at least 6 months ago.
Your tumor must have been tested for PD-L1 expression, which is a protein that can affect how the immune system responds to cancer. This test can be done on a previous tumor sample or a new biopsy.
You must have at least one tumor that can be measured by doctors using specific guidelines called RECIST v1.1.
Your overall health should be good, with an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. This is a scale that measures how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
Other specific criteria may apply as defined by the study protocol.

Who Cannot Join the Study?

Patients who have a different type of cancer than Non-small Cell Lung Cancer cannot participate.
Patients with cancer that has spread to other parts of the body, known as metastatic cancer, are not eligible.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not willing or able to follow the study procedures will be excluded.
Patients who have other serious health conditions that could interfere with the study treatment are not eligible.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies to the study drugs or similar medications will be excluded.
Patients who have received certain treatments for their cancer recently may not be eligible.
Patients with a history of certain heart conditions or other specific medical issues may be excluded.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Virgen del Rocío University Hospital	Sevilla	Spain
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Centre Hospitalier Universitaire De Nantes	Saint-Herblain	France
Idjeyj Ithkvwnq Fcoyerczqmqve Oacmkrrqdal	Rome	Italy
Hmketjtm Vjek deufmuzh	Barcelona	Spain
Iwkdjtte Cabzv	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	05.10.2023
Italy	Not recruiting	05.10.2023
Romania	Not recruiting	05.10.2023
Spain	Not recruiting	05.10.2023

Trial locations

Investigated drugs:

Tislelizumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is being used to see if it can help treat non-small cell lung cancer when combined with other treatments.

Investigated diseases:

Metastatic Non-small Cell Lung Cancer – This is a type of lung cancer that has spread from the lungs to other parts of the body. It originates in the epithelial cells of the lung and is characterized by uncontrolled cell growth. As the disease progresses, cancer cells can invade nearby tissues and organs. The spread, or metastasis, often occurs to the bones, brain, liver, or adrenal glands. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression can vary, with some patients experiencing rapid spread while others may have a slower course.

Non-small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of cases. It begins in the epithelial cells lining the lungs and is characterized by the formation of malignant tumors. The disease progresses as the cancer cells grow and divide uncontrollably, potentially invading nearby tissues. Over time, it can spread to other parts of the body, such as the lymph nodes, bones, or brain. Symptoms often include a persistent cough, shortness of breath, and weight loss. The rate of progression can vary significantly among individuals.

Trial ID:

2022-502738-18-00

Protocol code:

BGB-LC-201

NCT ID:

NCT05635708

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Tislelizumab, LBL-007, and BGB-15025 in Patients with Advanced Non-Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?