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 study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Geniko Nosokomeio Thessalonikis George Papanikolaou	Thessaloniki	Greece
Metropolitan General Hospital/Healthcare Facilities Operation And Management Single Member S.A	Cholargos	Greece
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy	Otwock	Poland
Nsuryqfa Iyrodyul Ofxjsthjx Iki Mxlwm Skvnlmvojbnjphtjctwgrpuddzuh Iaulzsme Bzaqspho	Cracow	Poland
Utjenqohonyfdt Clxyagm Kehndsjov	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	20.07.2020
Italy	Not recruiting	20.07.2020
Poland	Not recruiting	20.07.2020

Trial locations

Investigated drugs:

Atezolizumab

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.

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.

Trial ID:

2022-502988-37-00

Protocol code:

GO41767

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Atezolizumab, Carboplatin, and Etoposide with or Without Tiragolumab for Patients with Untreated Extensive-Stage Small Cell Lung Cancer

What is this study about?

Who Can Join the Study?

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