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Study of Tiragolumab and Atezolizumab for Patients with Advanced Non-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 non-small cell lung cancer (NSCLC). The study is investigating the effects of a new treatment combination involving two medications: tiragolumab and atezolizumab. Tiragolumab is an experimental drug that works as an anti-TIGIT antibody, while atezolizumab is an anti-PD-L1 antibody, which is already used in cancer treatment. The trial compares the combination of tiragolumab and atezolizumab with a combination of a placebo and atezolizumab.

The purpose of this study is to evaluate how effective the combination of tiragolumab and atezolizumab is in treating patients with previously untreated, locally advanced, unresectable, or metastatic PD-L1-selected NSCLC. The study will monitor participants over a period to assess their progression-free survival, which means the length of time during and after the treatment that a patient lives with the disease without it getting worse, and overall survival, which is the length of time from either the date of diagnosis or the start of treatment that patients diagnosed with the disease 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 is designed to be double-blinded, meaning neither the participants nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results. The trial will help determine if the new combination of medications can provide better outcomes for patients with 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 study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the experimental medication tiragolumab in combination with atezolizumab, while the other group will receive a placebo in combination with atezolizumab. This process is double-blinded, meaning neither you nor the study team will know which group you are in.

  2. Step 2

    Medication administration

    You will receive the medications through an intravenous infusion. This means the medication will be given directly into your vein using a needle. The dosage for atezolizumab is 1,200 mg. The frequency and duration of administration will be determined by the study protocol and your healthcare provider.

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. These check-ups will include physical exams, blood tests, and imaging tests to assess the progression of your condition.

  4. Step 4

    Progress evaluation

    Your progress will be evaluated based on specific criteria to determine how the treatment is affecting your condition. This includes measuring progression-free survival, which is the length of time during and after treatment that your cancer does not worsen, and overall survival, which is the length of time you live after starting the treatment.

  5. Step 5

    Completion of the study

    The study is expected to end by February 21, 2025. Upon completion, you will have a final evaluation to assess your overall health and the outcomes of the treatment. You will also have the opportunity to discuss any questions or concerns with your healthcare provider.

Who can join the trial?

5 criteria

  • Must be at least 18 years old and have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. This is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.
  • Must have non-small cell lung cancer (NSCLC) that is locally advanced or has come back and cannot be treated with surgery or radiation therapy, or has spread to other parts of the body (Stage IV). No previous treatment for cancer that has spread.
  • The tumor must show a certain level of a protein called PD-L1, which is checked using specific tests on the tumor tissue.
  • Must have a disease that can be measured using specific criteria known as Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
  • Must have adequate blood and organ function, meaning the body is working well enough to handle the treatment.

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 received any other cancer treatment within the last 28 days are not eligible.
  • Patients with severe heart problems, such as heart failure or a recent heart attack, cannot join the study.
  • Patients with uncontrolled high blood pressure are not allowed to participate.
  • Patients with active infections, including HIV, hepatitis B, or hepatitis C, are excluded.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible for the study.
  • Patients with a history of severe allergic reactions to similar drugs are excluded.
  • Patients who have had a major surgery within the last 4 weeks cannot participate.
  • Patients with brain metastases, which are cancer cells that have spread to the brain, are not eligible unless they have been treated and are stable.
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Investigated drugs

  • Tiragolumab

    is a type of medication known as an antibody. It is designed to help the body's immune system fight cancer by targeting a specific protein called TIGIT. This protein can sometimes help cancer cells hide from the immune system. By blocking TIGIT, tiragolumab may help the immune system recognize and attack cancer cells more effectively.

  • Atezolizumab

    is another type of antibody medication. It works by targeting a protein called PD-L1, which is found on the surface of some cancer cells. PD-L1 can prevent the immune system from attacking cancer cells. Atezolizumab blocks this protein, helping the immune system to detect and destroy cancer cells. It is used in this trial to treat patients with a specific type of lung cancer that has not been treated before and cannot be removed by surgery.

What is already known about the treatment

  • Tiragolumab

    Tiragolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials and is not yet widely used in standard medical practice. The main therapeutic indication for tiragolumab is non-small cell lung cancer (NSCLC), specifically in patients with advanced stages of the disease. At the molecular level, tiragolumab works by targeting a protein called TIGIT, which is involved in the immune system's ability to fight cancer cells. It is classified as an anti-TIGIT antibody, a type of immunotherapy that helps the body's immune system recognize and attack cancer cells.

  • Atezolizumab

    Atezolizumab is also administered as an intravenous infusion, allowing it to enter the bloodstream directly. It is an established medication in the treatment of various cancers, including non-small cell lung cancer (NSCLC). Atezolizumab is used to help the immune system fight cancer by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. This medication is classified as a checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses against cancer.

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 epithelial cells lining the lungs and can grow and spread to other parts of the body. The disease often progresses slowly compared to small cell lung cancer, but it can still spread to lymph nodes and distant organs. As it advances, symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of NSCLC can vary significantly depending on the stage at diagnosis and the specific characteristics of the cancer cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502482-17-00Protocol codeGO41717Estimated enrolment620 patientsSponsorF. Hoffmann-La Roche AG

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