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Study of Tiragolumab, Atezolizumab, and Chemotherapy for Patients with Non-Small Cell Lung Cancer (NSCLC)

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC). The trial is investigating the use of a combination of treatments, including two medications called Tiragolumab and Atezolizumab, along with chemotherapy. Tiragolumab is identified by the code name RO7092284. These medications are given as an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to explore how effective and feasible it is to use these treatments together before and after surgery in patients with NSCLC. The study is designed to follow patients over time to see how well the treatments work in reducing the cancer. Participants will receive the treatments over a period of time, and their progress will be monitored through regular hospital visits and follow-up examinations.

This trial is non-randomized, meaning all participants will receive the same treatment, and it is open-label, so both the researchers and participants know what treatment is being given. The study aims to provide valuable insights into the effectiveness of combining these treatments for NSCLC, potentially improving outcomes for patients undergoing surgery for this type of lung cancer.

1 joining the trial

Upon joining the trial, you will provide written informed consent, confirming your understanding and agreement to participate in the study.

You will be required to provide liquid and tissue samples for research purposes.

2 initial assessments

You will undergo initial assessments to confirm eligibility, including tests to ensure adequate bone marrow, kidney, and liver function.

A pregnancy test will be conducted for women of childbearing potential.

3 treatment phase

You will receive a combination of chemotherapy, atezolizumab, and tiragolumab as part of the treatment.

These medications will be administered through an intravenous infusion, which means they will be given directly into your vein.

The specific dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare team.

4 surgery

After the treatment phase, you will undergo surgery with the intent to remove the cancerous tissue.

The success of the surgery will be evaluated based on the major pathological response, which measures the extent of cancer cell death.

5 follow-up visits

You will have scheduled follow-up visits and examinations to monitor your health and the effectiveness of the treatment.

These visits are essential to ensure your well-being and to gather data for the study.

Who Can Join the Study?

  • Has provided written informed consent, which means you agree to participate in the study after being informed about all aspects of it.
  • Patient is 18 years or older at the time of signing the informed consent form.
  • Has a confirmed diagnosis of non-small cell lung cancer (NSCLC) of either squamous or non-squamous type.
  • The cancer is at a stage that can be surgically removed, specifically clinical stage II, IIIA, or IIIB (T3N2 only).
  • Has had proper disease staging using PET and/or CT scans within 42 days before starting the study treatment. These are imaging tests that help determine the extent of cancer.
  • Has at least one measurable lesion, which is a tumor that can be measured in size, according to specific guidelines (RECIST v1.1).
  • Has an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but is still able to carry out light work. ECOG is a scale used to assess how a disease affects a patient’s daily living abilities.
  • Has adequate lung and heart function to undergo surgery aimed at completely removing the lung cancer, according to specific medical guidelines.
  • Is eligible to receive a type of chemotherapy that includes a drug called platinum, which is used before surgery to shrink the tumor.
  • The patient is willing and able to follow the study protocol, which includes attending hospital visits for treatment and follow-up examinations.
  • The patient is willing and able to provide blood and tissue samples for additional research related to the study.
  • Has adequate bone marrow and kidney function, which includes having enough red blood cells, white blood cells, and platelets, and proper kidney function as measured by specific medical tests.
  • Has adequate liver function, which includes having normal levels of certain liver enzymes and bilirubin, a substance made by the liver.
  • Female patients who can have children must have a negative pregnancy test within 7 days before starting the trial.
  • Female patients who can have children must use a highly effective birth control method during the study and for 5 months after the last dose of the study drug. Male patients who are sexually active with women who can have children must also use a highly effective birth control method during the study and for at least 5 months after the last dose of the study drug. Women who cannot have children and men who are unable to father children do not need to use birth control.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides non-small cell lung cancer (NSCLC) cannot participate.
  • Patients who have had a different cancer in the past, unless it was successfully treated and has not returned, are excluded.
  • Patients with serious heart problems, such as heart failure or a recent heart attack, are not eligible.
  • Patients with uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, including HIV, hepatitis B, or hepatitis C, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had an organ transplant are not eligible.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are excluded.
  • Patients who are currently participating in another clinical trial cannot join this study.
  • Patients who have had a severe allergic reaction to similar drugs in the past are not eligible.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Udixdqrczhehhrcezqnej Evczj All Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
01.01.2023

Trial locations

Investigated drugs:

Tiragolumab is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, tiragolumab is used to enhance the body’s natural defenses against non-small cell lung cancer (NSCLC) by blocking a specific protein that can prevent the immune system from doing its job.

Atezolizumab is another immune checkpoint inhibitor used in this trial. It helps the immune system fight cancer by blocking a protein that can stop immune cells from attacking cancer cells. By doing this, atezolizumab aims to boost the immune response against NSCLC, making it harder for the cancer to grow and spread.

Chemotherapy refers to a group of drugs that are used to kill or slow the growth of cancer cells. In this trial, chemotherapy is combined with tiragolumab and atezolizumab to provide a comprehensive approach to treating NSCLC. Chemotherapy targets rapidly dividing cells, which include cancer cells, and is used to shrink tumors and reduce the risk of cancer spreading before and after surgery.

Investigated diseases:

Non-small cell lung cancer (NSCLC) – Non-small cell lung cancer is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It generally starts in the tissues of the lungs and can spread to other parts of the body. The disease often progresses slowly compared to other types of lung cancer. As it advances, it can cause symptoms like persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary, with some cases remaining localized while others spread to lymph nodes or distant organs. The disease’s course can be influenced by factors such as the specific subtype and the patient’s overall health.

Trial ID:
2022-501322-38-00
Protocol code:
NeoTRACK
NCT ID:
NCT05825625
Trial Phase:
Therapeutic exploratory (Phase II)

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