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Study of Atezolizumab for Patients with Advanced Non-Small Cell Lung Cancer After Chemotherapy and Radiation Therapy

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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 known as Non-Small Cell Lung Cancer (NSCLC). The study involves patients who have a specific stage of this cancer, called locally advanced, unresectable Stage III. These patients have already received a combination of chemotherapy and radiotherapy, which are treatments that use drugs and high-energy rays to kill cancer cells. The trial is testing a medication called atezolizumab, also known by its code name RO5541267, which is given as an infusion, meaning it is delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective atezolizumab is in preventing the cancer from getting worse over a period of 12 months. Patients participating in the trial will receive atezolizumab after completing their initial treatments of chemotherapy and radiotherapy. The study will monitor the patients' health and the progression of their cancer over time to see if the medication helps in keeping the cancer from advancing.

Throughout the study, patients will be regularly assessed to check for any changes in their condition and to ensure their safety while taking atezolizumab. The trial aims to gather information on how well the medication works and any side effects it may cause. This information will help in understanding the potential benefits of atezolizumab for patients with this type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing at least two cycles of platinum-based chemotherapy with radiotherapy. This treatment should have been completed within 1 to 42 days before starting the study.
Step 2
Initial assessment
A whole-body PET-CT scan is performed to confirm the stage of the lung cancer. This scan should be done before and within 42 days of the first dose of chemotherapy and radiotherapy.
Step 3
Treatment with atezolizumab
The medication used in this study is atezolizumab, known by the brand name Tecentriq. It is administered as an intravenous infusion, which means it is given directly into a vein.
The dosage is 840 mg, and it is provided as a solution for infusion.
Step 4
Monitoring and follow-up
The primary goal is to evaluate the effectiveness of atezolizumab in preventing disease progression over 12 months.
Regular assessments are conducted to monitor progression-free survival, overall survival, and response to treatment.
The study also tracks any side effects experienced during the treatment period.
Step 5
Completion of the study
The study is expected to conclude by September 4, 2026. Participants will be monitored for progression-free survival and overall survival rates at various intervals, including 12, 18, 24, and 36 months.

Who can join the trial?

8 criteria

Must be able to follow the study rules and agree to stay in the study after treatment.
Must have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced and cannot be removed by surgery. This can be either squamous or non-squamous type.
Must have had a whole-body scan called PET-CT (a special imaging test) done for staging purposes, from the base of the skull to mid-thighs, before and within 42 days of starting the combined treatment.
Must have completed at least two cycles of a specific type of chemotherapy called platinum-based chemotherapy given at the same time as radiotherapy. This should have been finished between 1 to 42 days before the start of the study. One cycle of this treatment lasts 21 or 28 days.
The radiotherapy part of the treatment must have been given at a total dose of 60 (± 10%) Gy, which is a unit of radiation. This should have been done using a method called IMRT (preferred) or a 3D-conforming technique.
Must have a known result for a test called PD-L1, which is determined by a specific test on a tumor tissue sample. This can be from a previous sample or a new biopsy taken before starting the combined treatment.
Both males and females can participate in the study.
Participants can be from vulnerable populations, which means they might need extra protection or care.

Who cannot join the trial?

5 criteria

Patients who have not been diagnosed with Non-Small Cell Lung Cancer (NSCLC).
Patients who have not received at least two cycles of platinum-based concurrent chemoradiation therapy (cCRT). This is a treatment that combines chemotherapy and radiation therapy at the same time.
Patients whose cancer has progressed after receiving the above treatment.
Patients who are not in the age range specified for the study.
Patients who are not able to give informed consent or are part of a vulnerable population that requires special protection.

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Verified sites

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

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Hospital Vall d’Hebron
Barcelona, Spain
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University Medical Center Ljubljana
Ljubljana, Slovenia

Trial locations

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Investigated drugs

Atezolizumab
is a medication used in this study to help treat patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC). It is given to patients whose cancer has not worsened after they have received a combination of chemotherapy and radiation therapy. The goal of using atezolizumab is to see if it can help keep the cancer from progressing for at least 12 months.
Platinum-Based Concurrent Chemoradiation Therapy (cCRT)
is a treatment that combines chemotherapy and radiation therapy at the same time. This therapy is used to treat patients with locally advanced lung cancer that cannot be removed by surgery. The chemotherapy part involves using drugs that contain platinum, which helps to kill cancer cells and make the radiation therapy more effective. This combination is given to patients before they receive atezolizumab in the study.

Atezolizumab

What is already known about the treatment

Atezolizumab – Atezolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating locally advanced, unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) in patients who have not shown disease progression after receiving platinum-based concurrent chemoradiation therapy. The medication works by targeting and inhibiting the PD-L1 protein, which can help the immune system recognize and attack cancer cells more effectively. Atezolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can spread to other parts of the body if not managed. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it may lead to more severe respiratory issues and other systemic symptoms.