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Study of Atezolizumab, Carboplatin, and Etoposide with or Without Tiragolumab for Patients with Untreated Extensive-Stage 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 known as extensive-stage small cell lung cancer (ES-SCLC). The study is investigating the effects of a combination of medications, including atezolizumab, carboplatin, and etoposide, with or without an additional medication called tiragolumab. Atezolizumab is a medication that helps the immune system fight cancer, while carboplatin and etoposide are chemotherapy drugs that work to stop cancer cells from growing. Tiragolumab is an experimental drug that is being tested to see if it can enhance the effects of atezolizumab.

The purpose of this study is to evaluate how well the combination of these drugs works in treating patients who have not yet received treatment for their ES-SCLC. Some participants will receive a placebo instead of tiragolumab to compare the outcomes. The study will monitor participants over a period of time to assess their progression-free survival, which means the length of time during and after treatment that a patient lives with the disease without it getting worse, and overall survival, which is the length of time from the start of treatment that patients are still alive.

Participants in the study will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will last for up to 72 weeks, during which time participants will have regular check-ups and assessments to monitor their health and the effectiveness of the treatment. The study aims to provide valuable information on whether adding tiragolumab to the treatment regimen can improve outcomes for patients with ES-SCLC.

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
Upon joining the study, eligibility is confirmed based on specific criteria such as performance status, confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC), and no prior systemic treatment for ES-SCLC.
Step 2
Initial treatment phase
The treatment involves receiving medications through an intravenous (IV) infusion. The medications include atezolizumab and carboplatin and etoposide, with or without tiragolumab.
Atezolizumab is administered as a 1,200 mg concentrate for solution for infusion. Tiragolumab, if included, is also given as a concentrate for solution for infusion.
Step 3
Treatment schedule
The treatment is administered in cycles. Each cycle typically lasts for a specified period, during which the medications are given at regular intervals as determined by the study protocol.
Step 4
Monitoring and assessments
Throughout the study, regular monitoring and assessments are conducted to evaluate the effectiveness of the treatment. This includes measuring progression-free survival and overall survival.
Additional assessments may include checking the response rate, duration of response, and monitoring for any adverse events.
Step 5
Completion of treatment
The study is estimated to conclude by December 21, 2024. Upon completion, final assessments are conducted to evaluate the overall outcomes of the treatment.

Who can join the trial?

9 criteria

Must have a type of lung cancer called small cell lung cancer (SCLC).
Must have a specific stage of this cancer called extensive-stage small cell lung cancer (ES-SCLC).
Must not have received any previous treatment for ES-SCLC.
Must have a performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
Must have cancer that can be measured using specific medical criteria.
Must have good blood and organ function, meaning the body is working well enough to handle treatment.
If taking blood thinners, the medication must be stable, meaning it is working well without causing problems.
Both men and women can participate.
Participants can be from a vulnerable population, meaning they might need extra protection or care.

Who cannot join the trial?

1 criterion

Patients with a history of or current presence of **brain metastases**. Brain metastases are cancer cells that have spread to the brain from another part of the body.

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Verified sites

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

Azienda Ospedaliera Universitaria Federico II Di Napoli
Verified
Naples, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Verified
Cracow, Poland

Trial locations

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Investigated drugs

Atezolizumab
is a medication used in this trial to help the immune system attack cancer cells. It is a type of immunotherapy that works by blocking a protein that prevents the immune system from effectively fighting cancer.
Carboplatin
is a chemotherapy drug used to treat various types of cancer, including lung cancer. It works by damaging the DNA of cancer cells, which stops them from growing and dividing.
Etoposide
is another chemotherapy medication used in this trial. It helps to kill cancer cells by interfering with their DNA, preventing them from multiplying.
Tiragolumab
is an experimental drug being tested in this trial. It is an antibody that targets a specific protein on immune cells, potentially enhancing the body's immune response against cancer cells.

What is already known about the treatment

Atezolizumab
Atezolizumab is administered intravenously and is currently used in the treatment of various cancers, including small cell lung cancer (SCLC). It is a monoclonal antibody that works by blocking the PD-L1 protein, which helps the immune system detect and attack cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor and is well-documented in medical literature for its role in cancer immunotherapy.
Carboplatin
Carboplatin is given intravenously and is widely used in chemotherapy for different types of cancer, including small cell lung cancer (SCLC). It works by binding to DNA in cancer cells, causing damage that prevents the cells from dividing and growing. Carboplatin is classified as a platinum-based chemotherapy drug and is well-established in medical practice for its effectiveness in cancer treatment.
Etoposide
Etoposide is administered either orally or intravenously and is commonly used in combination with other drugs to treat small cell lung cancer (SCLC). It acts by inhibiting an enzyme called topoisomerase II, which is necessary for DNA replication, thereby preventing cancer cell division. Etoposide is classified as a topoisomerase inhibitor and is a well-known agent in cancer chemotherapy.
Tiragolumab
Tiragolumab is administered intravenously and is currently being studied in clinical trials for its potential use in treating small cell lung cancer (SCLC). It is an anti-TIGIT antibody that works by enhancing the immune system's ability to fight cancer cells. Tiragolumab is classified as an immune checkpoint inhibitor and is under investigation to determine its efficacy and safety in cancer treatment.

Investigated diseases

Small Cell Lung Cancer (SCLC) – Small cell lung cancer is a fast-growing type of lung cancer that primarily affects smokers. It is characterized by small cells that multiply quickly and form large tumors in the lungs. SCLC often spreads rapidly to other parts of the body, including the brain, liver, and bones. The disease is typically divided into two stages: limited stage, where cancer is confined to one lung and nearby lymph nodes, and extensive stage, where it has spread beyond the lung. Symptoms may include coughing, chest pain, shortness of breath, and weight loss. Due to its aggressive nature, SCLC requires prompt medical attention.