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Study on the Effectiveness and Safety of Atezolizumab and Drug Combination for Patients with Metastatic 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 treatments for metastatic non-small cell lung cancer (NSCLC), a type of lung cancer that has spread to other parts of the body. The study will explore the effectiveness and safety of various treatment combinations that include immunotherapy, which is a type of treatment that helps the immune system fight cancer. The medications being tested in this study include Tecentriq (atezolizumab), Docetaxel Accord (docetaxel), Camonsertib, Trajenta (linagliptin), and Avastin (bevacizumab). Some patients may receive a placebo as part of the study.

The purpose of the study is to evaluate how well these treatment combinations work in patients with metastatic non-small cell lung cancer. Participants in the study will receive one or more of these treatments, and their response to the treatment will be monitored over time. The study will also assess the safety of these treatments by observing any side effects or changes in health status. The study is designed to provide valuable information on the potential benefits and risks of these treatment combinations for patients with this type of lung cancer.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the progress of the cancer. These tests may include imaging scans and blood tests to evaluate the effectiveness of the treatment and to ensure the safety of the participants. The study aims to gather data that could lead to improved treatment options for patients with metastatic non-small cell lung cancer in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, confirmation of a diagnosis of metastatic non-small cell lung cancer (NSCLC) is required.
A tumor sample is needed to determine specific markers, such as PD-L1.
Tests for HIV, hepatitis B, and hepatitis C are conducted to ensure eligibility.
Step 2
Treatment phase
The treatment involves multiple combinations of immunotherapy and other medications.
Medications include Tecentriq (atezolizumab) administered via intravenous infusion, Docetaxel Accord via intravenous infusion, Camonsertib in capsule form, Trajenta (linagliptin) as film-coated tablets, and Avastin (bevacizumab) via intravenous infusion.
The specific dosage, frequency, and duration of each medication are determined by the study protocol and the patient's response.
Step 3
Monitoring and evaluation
Regular assessments are conducted to evaluate the objective response rate (ORR) to the treatment.
Secondary evaluations include progression-free survival (PFS), overall survival (OS), duration of response (DOR), and disease control rate (DCR).
Monitoring includes checking for any adverse events and changes in vital signs, electrocardiogram results, and laboratory tests.
Step 4
Completion of the study
The study is estimated to conclude by November 17, 2025.
Final assessments will be conducted to determine the overall efficacy and safety of the treatment combinations.

Who can join the trial?

10 criteria

The patient must have a type of lung cancer called metastatic non-small cell lung cancer (NSCLC). This means the cancer has spread from the lungs to other parts of the body.
The cancer must be confirmed through tests called histology or cytology, which examine cells or tissues under a microscope.
A sample of the tumor must be available for testing to check for certain markers, like PD-L1, which can help guide treatment.
The patient must have a disease that can be measured using specific criteria known as the Response Evaluation Criteria in Solid Tumors, Version 1.1. This helps doctors assess how the cancer responds to treatment.
The patient must test negative for HIV (Human Immunodeficiency Virus) during the screening process.
The patient must test negative for hepatitis B during screening. If the initial test is positive, a follow-up test must show no active virus.
The patient must test negative for hepatitis C during screening. If the initial test is positive, a follow-up test must show no active virus.
The study is open to both male and female participants.
The study includes adults, typically those aged 18 and older.
The study may include individuals considered part of a vulnerable population, which means they might need extra protection or care.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer than metastatic non-small cell lung cancer (NSCLC) cannot participate. This means the cancer has spread from the lung to other parts of the body.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not part of the specified clinical trial groups cannot participate. This refers to specific categories or characteristics required for the study.
Patients who are not female or male cannot participate, as the study includes both genders.
Patients who are considered part of a vulnerable population cannot participate. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.

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Verified sites

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

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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Investigated drugs

Atezolizumab
is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells, specifically in patients with metastatic non-small cell lung cancer.
Bevacizumab
is another medication used in the trial. It is a type of targeted therapy that works by inhibiting the growth of blood vessels that supply nutrients to tumors, thereby slowing or stopping the growth of cancer.
Carboplatin
is a chemotherapy drug included in the study. It works by damaging the DNA of cancer cells, which prevents them from dividing and growing.
Pemetrexed
is also part of the trial. This chemotherapy medication interferes with the growth of cancer cells by blocking the enzymes needed for their replication.
Paclitaxel
is used in the trial as well. It is a chemotherapy drug that stops cancer cells from dividing by interfering with the normal function of microtubules, which are structures that help cells divide.
Ipatasertib
is an investigational drug in the study. It is designed to block certain proteins that are involved in the growth and survival of cancer cells, potentially enhancing the effects of other cancer treatments.

What is already known about the treatment

Immunotherapy-Based Treatment Combinations – These treatments are administered intravenously, meaning they are given directly into a vein. They are currently being studied in clinical trials for their effectiveness and safety in treating metastatic non-small cell lung cancer (NSCLC). The main therapeutic indication is to improve the response rate in patients with this type of lung cancer. At the molecular level, these treatments work by stimulating the body's immune system to recognize and attack cancer cells more effectively. They are classified under immunotherapy, which is a type of cancer treatment that helps the immune system fight cancer.

Investigated diseases

Metastatic Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the cells lining the lungs and has spread to other parts of the body. It is the most common form of lung cancer, accounting for about 85% of cases. The disease progresses as cancer cells grow and form tumors in the lungs, which can then metastasize to other organs such as the brain, bones, or liver. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the cancer spreads, it can lead to more severe symptoms and complications. The progression of the disease varies depending on factors like the cancer's genetic makeup and the patient's overall health.