Study of Tiragolumab, Atezolizumab, and Pembrolizumab for Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying treatments for a type of lung cancer known as non-squamous non-small cell lung cancer (NSCLC). The study involves several medications, including Tiragolumab, Atezolizumab, Pembrolizumab (also known by its code name MK-3475), and chemotherapy drugs Pemetrexed and Carboplatin/Cisplatin. The purpose of the study is to evaluate the effectiveness of these treatments in patients who have not received prior treatment for their advanced lung cancer.

Participants in the study will be randomly assigned to one of two groups. One group will receive a combination of Tiragolumab and Atezolizumab along with Pemetrexed and Carboplatin/Cisplatin. The other group will receive Pembrolizumab with Pemetrexed and Carboplatin/Cisplatin. Some participants may receive a placebo instead of Tiragolumab. The study will monitor how well the cancer responds to these treatments and how long patients live without the cancer getting worse.

The trial will take place over a period of time, with regular assessments to check the progress of the disease and the overall health of the participants. The study aims to provide valuable information on the best treatment options for patients with this type of lung cancer, focusing on improving survival rates and quality of life. Participants will receive their treatments through an intravenous infusion, which means the medication is given directly into a vein.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the performance status, tumor characteristics, and previous treatment history.

Tests are performed to ensure the absence of active infections such as HIV, hepatitis B, and hepatitis C.

2 randomization

Participants are randomly assigned to one of two treatment groups. This process is double-blind, meaning neither the participant nor the healthcare provider knows which group the participant is in.

3 treatment administration

Participants in the first group receive tiragolumab and atezolizumab in combination with pemetrexed and either carboplatin or cisplatin. These medications are administered through an intravenous infusion.

Participants in the second group receive pembrolizumab in combination with pemetrexed and either carboplatin or cisplatin. These medications are also administered through an intravenous infusion.

4 treatment schedule

The treatment is given in cycles. Each cycle lasts for a specified period, during which the medications are administered according to the study protocol.

5 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and other evaluations to measure the size of the tumor and check for any progression of the disease.

Participants are also monitored for any side effects or adverse reactions to the treatment.

6 follow-up

After completing the treatment cycles, participants enter a follow-up phase. This involves periodic assessments to monitor long-term outcomes and overall survival.

The follow-up phase continues until the end of the study or until the participant withdraws from the study.

Who Can Join the Study?

The patient must have a Performance Status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG). This means the patient should be fully active or have some symptoms but still be able to carry out light work.
The patient must have non-squamous non-small cell lung cancer (NSCLC) that is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The cancer should not be treatable with surgery or combined chemotherapy and radiation aimed at curing it.
The patient should not have received any previous treatment that affects the whole body for their metastatic non-squamous NSCLC.
The patient’s tumor must have a known PD-L1 status. PD-L1 is a protein that can affect how the immune system responds to cancer.
The patient must have a measurable disease as defined by specific criteria called RECIST v1.1. This means the cancer can be measured in size to see if it changes during treatment.
The patient must have a negative HIV test and tests showing no active hepatitis B or hepatitis C infections at the time of screening.
The study is open to both male and female patients.
The study includes patients who are considered part of a vulnerable population, meaning they may need special protection or consideration.

Who Cannot Join the Study?

Patients with a different type of lung cancer than non-squamous non-small cell lung cancer (NSCLC) cannot participate. This means if you have a type of lung cancer that is not NSCLC, you are not eligible.
Patients who are not within the specified age range for the study cannot participate. The study is looking for participants within certain age groups.
Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
Patients who are part of a vulnerable population, which means they might need special protection or care, may not be eligible to participate.
Patients who have other medical conditions that could interfere with the study or make it unsafe for them to participate cannot join.
Patients who are currently participating in another clinical trial or have recently participated in one may not be eligible.
Patients who are pregnant or breastfeeding cannot participate in the study.
Patients who have had a recent major surgery or have not fully recovered from a previous surgery may not be eligible.
Patients who have a history of severe allergic reactions to any of the study drugs or similar drugs cannot participate.
Patients who have an active infection or other serious medical condition that could interfere with the study cannot join.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Warminsko-Mazurskie Centrum Chorob Pluc W Olsztynie	Olsztyn	Poland
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Del Mar	Barcelona	Spain
Vitaz	Sint-Niklaas	Belgium
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Vincentius-Diakonissen-Kliniken gAG	Karlsruhe	Germany
Odense University Hospital	Odense	Denmark
Hospital Clinic De Barcelona	Barcelona	Spain
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Hospital Son Llatzer	Palma	Spain
Hospital Universitario Virgen De Valme	Sevilla	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Centre Hospitalier Universitaire De Rennes	Rennes	France
Rigshospitalet	Copenhagen	Denmark
HELIOS Klinikum Emil von Behring GmbH	Berlin	Germany
Region Sjaelland	Holbæk	Denmark
Camtsyhyk Uabhciokxtjyqf Svqsillpi	Woluwe-Saint-Lambert	Belgium
Ummbnbhgooxmklfsspfmg Gipmpnr uta Mridhme Gqiu	Marburg	Germany
Iroddtal Ccjtdy Dtixhdriynvvlnhpb	L'hospitalet De Llobregat	Spain
Ojhxvgmbrzvhvkybylzdnszuqd	Aalst	Belgium
Alzfqlvxwn Plwjhmsy Harwjudr Da Mdqvychvs	Marseille	France
Unz Mnbtamsefspy	Yvoir	Belgium
Frwrmbbgi Pgbl Lf Iwohgpjhxdoxk Bipupbjry Dmr Hnprscse Ucedbjroraxxi Lu Pgd	Madrid	Spain
Hsxxmkjk Usgcikvascasc dd A Cdtudy	A Coruna Galicia	Spain
Hjkcaadq Umcbcferofhgvh Sbumhvyosn &cgpzbb Hyopuub dx Hartswakiyg	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	31.01.2021
Denmark	Not recruiting	31.01.2021
France	Not recruiting	31.01.2021
Germany	Not recruiting	31.01.2021
Poland	Not recruiting	31.01.2021
Spain	Not recruiting	31.01.2021

Trial locations

Investigated drugs:

Tiragolumab is an investigational medication being studied for its potential to enhance the immune system’s ability to fight cancer. It is used in combination with other cancer treatments to see if it can improve outcomes for patients with advanced non-squamous non-small-cell lung cancer.

Atezolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used in combination with other medications to treat certain types of lung cancer.

Pemetrexed is a chemotherapy drug that works by interfering with the growth of cancer cells. It is often used in combination with other drugs to treat non-small-cell lung cancer.

Carboplatin is a chemotherapy medication that helps to stop the growth of cancer cells. It is commonly used in combination with other drugs to treat various types of cancer, including lung cancer.

Cisplatin is another chemotherapy drug that works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is used in combination with other treatments for lung cancer.

Pembrolizumab is an immunotherapy drug that helps the immune system detect and fight cancer cells. It is used in combination with other medications to treat advanced non-small-cell lung cancer.

Non-squamous non-small cell lung cancer (NSCLC) – This is a type of lung cancer that does not involve the squamous cells, which are flat cells lining the airways. It is one of the most common types of lung cancer and typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the outer parts of the lungs and can spread to other parts of the body. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms. Early detection is crucial for managing the disease effectively.

Trial ID:

2022-502031-20-00

Protocol code:

BO42592

Trial Phase:

Therapeutic use (Phase IV)

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Study of Tiragolumab, Atezolizumab, and Pembrolizumab for Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer

What is this study about?

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