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Study on the Safety and Effectiveness of GB1211 and Atezolizumab for Patients with Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC). The study is testing a new treatment that combines two medications: GB1211, which is a galectin-3 inhibitor, and atezolizumab, a medication that helps the immune system fight cancer. The purpose of the study is to investigate the safety and effectiveness of this combination in patients with NSCLC.

The study is divided into different parts. Initially, all participants will receive the treatment to see how well it is tolerated. After this, participants will be randomly assigned to receive either the combination of GB1211 and atezolizumab or atezolizumab with a placebo. This part of the study is conducted without participants knowing which treatment they are receiving. The study will also include an extension phase to observe the long-term effects of the treatment.

Participants will take part in regular check-ups and assessments to monitor their health and the progress of their cancer. The study aims to provide valuable information on whether the combination of GB1211 and atezolizumab can improve outcomes for patients with NSCLC. The study is expected to continue until 2025, allowing researchers to gather comprehensive data on the treatment's safety and effectiveness over time.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
The study begins with an open-label phase where the safety and tolerability of GB1211 at a dose of 200 mg, taken twice daily, is assessed in combination with atezolizumab. Atezolizumab is administered as an intravenous infusion at a dose of 1200 mg every three weeks.
This phase aims to determine the appropriate dose of GB1211 when used with atezolizumab.
Step 2
Randomized treatment phase
Participants are randomly assigned to receive either GB1211 with atezolizumab or a placebo with atezolizumab. This phase is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo.
The primary goal is to compare the safety and effectiveness of GB1211 with atezolizumab against the placebo with atezolizumab by measuring changes in tumor size at week 12.
Step 3
Extension study phase
Participants continue to receive treatment to assess the long-term safety and tolerability of GB1211 in combination with atezolizumab compared to atezolizumab alone.
This phase focuses on monitoring any adverse effects and the overall health outcomes over an extended period.

Who can join the trial?

15 criteria

Must be at least 18 years old at the time of signing the consent form.
Must have been diagnosed with a type of lung cancer called **Non-Small Cell Lung Cancer (NSCLC)**, either at stage IIIB or stage IV. Stage IIIB means the cancer has spread to nearby areas, and stage IV means it has spread to distant parts of the body.
Must have a **measurable disease**, which means the cancer can be measured using specific medical guidelines.
The cancer must show a protein called **PD-L1** on at least 50% of the tumor cells or on immune cells covering at least 10% of the tumor area. This is determined using specific medical tests.
Must agree to have a tumor sample taken for testing before starting the study treatment.
If taking blood thinners, the medication must be stable and not changing.
Must have good blood and organ function, as shown by specific lab tests done within 14 days before starting the study treatment. These tests check things like blood cell counts, liver function, and kidney function.
Must have a performance status of 0 to 1 on a scale used to assess how well a person can perform daily activities.
Must not have received chemotherapy for advanced or metastatic cancer before, but previous treatment for earlier stages is allowed if it was completed at least 4 weeks before.
Must not have received treatments called **immune checkpoint inhibitors** before.
Must be eligible to receive a medication called **atezolizumab** at a dose of 1200 mg every 3 weeks, as described in its product information.
Must provide a signed consent form agreeing to participate in the study.
Must be able to follow the study rules and procedures, as judged by the study doctor.
Women who can have children must agree to avoid pregnancy by not having heterosexual intercourse or using birth control and must agree not to donate eggs.
Men must agree to avoid fathering a child by not having heterosexual intercourse or using birth control and must agree not to donate sperm.

Who cannot join the trial?

11 criteria

Patients who have a different type of cancer other than Non-Small Cell Lung Cancer (NSCLC).
Patients who are currently receiving treatment with other experimental drugs.
Patients who have had a severe allergic reaction to similar medications in the past.
Patients with serious heart problems that are not well controlled.
Patients with severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that requires treatment.
Patients who have a history of another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer.
Patients who have a condition that affects their immune system, like HIV or AIDS.
Patients who have had a major surgery within the last 4 weeks.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Centr Georges Francois Leclerc
Dijon, France
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Centre Hospitalier Regional Universitaire De Tours
Tours, France
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Centre Hospitalier Universitaire De Montpellier
Montpellier, France

Trial locations

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Investigated drugs

GB1211
is a medication being studied for its potential to treat Non-Small Cell Lung Cancer (NSCLC). It works as a galectin-3 inhibitor, which means it targets and blocks a specific protein that may play a role in cancer progression. The study aims to evaluate the safety and effectiveness of GB1211 when used together with another medication, atezolizumab.
Atezolizumab
is an immunotherapy drug used in the treatment of various cancers, including Non-Small Cell Lung Cancer (NSCLC). It works by helping the immune system recognize and attack cancer cells. In this study, atezolizumab is being used in combination with GB1211 to see if the two drugs together can improve treatment outcomes for patients with NSCLC.

What is already known about the treatment

GB1211
GB1211 is administered orally and is currently being studied in combination with atezolizumab for its safety and effectiveness in treating Non-Small Cell Lung Cancer (NSCLC). It is in the clinical trial phase, with ongoing research to determine its potential benefits and risks. The main therapeutic indication for GB1211 is NSCLC, where it acts as a galectin-3 inhibitor, potentially interfering with cancer cell growth and spread. It belongs to the pharmacological class of galectin inhibitors, which are being explored for their role in cancer therapy.
Atezolizumab
Atezolizumab is administered via intravenous infusion and is an established medication used in the treatment of various cancers, including Non-Small Cell Lung Cancer (NSCLC). It is approved for use in several countries and is well-documented in medical literature. The primary therapeutic indication for atezolizumab is NSCLC, where it functions as an immune checkpoint inhibitor, helping the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody targeting the PD-L1 protein, enhancing the body's immune response against tumors.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – 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 is characterized by the uncontrolled growth of cells in the lung tissues, which can form tumors. As the disease progresses, these tumors can grow larger and may spread to other parts of the body, a process known as metastasis. Symptoms often include a persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary greatly among individuals, with some experiencing rapid growth and others having a slower course. Early detection is crucial for managing the disease effectively.