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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 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 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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

15 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

  • Tiragolumab

    Tiragolumab is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its potential use in treating non-small cell lung cancer (NSCLC). The main therapeutic indication for tiragolumab is to enhance the immune system's ability to fight cancer cells. At the molecular level, tiragolumab works by blocking a protein called TIGIT, which can suppress the immune response against cancer. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system recognize and attack cancer cells more effectively.

  • Atezolizumab

    Atezolizumab is also administered intravenously, delivered directly into the bloodstream through an injection. It is an established medication in the treatment of various cancers, including non-small cell lung cancer (NSCLC), and is well-documented in medical literature. The primary therapeutic use of atezolizumab is to boost the immune system's response to cancer. It functions by inhibiting the PD-L1 protein, which can prevent the immune system from attacking cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor, helping the body's natural defenses to better identify and destroy cancer cells.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501322-38-00Protocol codeNeoTRACKEstimated enrolment46 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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