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Study on Tiragolumab and Atezolizumab for Patients with Resected Stage IIB-IIIB Non-Small Cell Lung Cancer After Chemotherapy

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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 involves participants who have undergone surgery to remove the cancer and have received chemotherapy afterward. The trial is testing the effectiveness and safety of a combination of two medications, Tiragolumab and Atezolizumab, compared to a combination of a placebo and Atezolizumab. Tiragolumab and Atezolizumab are given as infusions, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate how well the combination of Tiragolumab and Atezolizumab works in preventing the return of cancer in patients whose tumors have a specific protein called PD-L1. The study will also look at the safety of these medications and how they affect the quality of life of the participants. Participants will receive the treatment over a period of up to 12 months, and their health will be monitored regularly to assess the effects of the treatment.

Throughout the study, researchers will collect information on how long participants remain free of cancer, any side effects they experience, and their overall survival. The study will also measure the levels of Tiragolumab and Atezolizumab in the blood at different times to understand how the body processes these medications. This trial aims to provide valuable insights into the potential benefits of combining Tiragolumab with Atezolizumab for treating NSCLC.

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, eligibility is confirmed based on specific criteria, including a diagnosis of non-small cell lung cancer (NSCLC) and previous treatment with surgery and chemotherapy.

    Participants must have a performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the participant's health status and recovery from previous treatments.

    This includes ensuring no unresolved side effects greater than grade 2 from prior chemotherapy.

  3. Step 3

    Treatment phase

    Participants receive either tiragolumab plus atezolizumab or a placebo plus atezolizumab.

    Both medications are administered through an intravenous infusion.

    The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the participant's response to treatment and any side effects.

    This includes measuring disease-free survival and overall survival rates, as well as evaluating health-related quality of life.

  5. Step 5

    Completion of study

    The study is estimated to conclude by April 30, 2039.

    Participants will have follow-up assessments to determine long-term outcomes and any lasting effects of the treatment.

Who can join the trial?

9 criteria

  • Must have a diagnosis of Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer.
  • Must have an Eastern Cooperative Oncology Group performance status of 0 or 1, which means the person is fully active or has some symptoms but can still do light work.
  • Must have a confirmed diagnosis of Stage IIB, IIIA, or certain types of Stage IIIB NSCLC, which are specific stages of lung cancer.
  • Must have had a complete resection of NSCLC, meaning the tumor was completely removed with no remaining cancer cells.
  • Must have had a procedure called mediastinal lymph node systematic sampling, which involves checking certain lymph nodes for cancer, though a more thorough procedure called mediastinal lymph node dissection is preferred.
  • Must have received between one to four cycles of adjuvant histology-based platinum doublet chemotherapy, which is a type of cancer treatment given after surgery. This includes drugs like cisplatin or carboplatin, combined with other drugs such as pemetrexed, gemcitabine, docetaxel, vinorelbine, etoposide, or paclitaxel.
  • Must have recovered well from surgery and chemotherapy, with no severe ongoing side effects.
  • Both males and females can participate.
  • Participants should not be from vulnerable populations, meaning they should not be in a situation that makes them more at risk or unable to give informed consent.

Who cannot join the trial?

4 criteria

  • Patients with other types of cancer besides Non-Small Cell Lung Cancer cannot participate.
  • Patients who have not reached the required age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they need special protection, cannot participate.
  • Patients who do not meet the specific health conditions required for the study cannot participate.
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Investigated drugs

  • Tiragolumab

    is an investigational medication being studied for its potential to help the immune system fight cancer. It is being tested in combination with another medication to see if it can improve outcomes for patients with certain types of lung cancer.

  • Atezolizumab

    is a medication that helps the immune system attack cancer cells. It is used in this study to see if it can help prevent the return of lung cancer after surgery and chemotherapy.

What is already known about the treatment

  • Tiragolumab

    Tiragolumab is administered intravenously and is currently being studied in clinical trials for its potential use in treating non-small cell lung cancer. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for tiragolumab is in combination with atezolizumab for patients with completely resected, PD-L1 positive non-small cell lung cancer. At the molecular level, tiragolumab works by targeting and inhibiting the TIGIT protein, which may enhance the immune system's ability to fight cancer cells. It is classified as an immune checkpoint inhibitor.

  • Atezolizumab

    Atezolizumab is administered intravenously and is an established medication used in the treatment of various cancers, including non-small cell lung cancer. It is approved for use in medical practice and is well-documented in medical literature. The main therapeutic indication for atezolizumab is to treat patients with PD-L1 positive non-small cell lung cancer, often in combination with other therapies. Its mechanism of action involves blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. Atezolizumab is classified as an immune checkpoint inhibitor.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically begins in the cells lining 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 may lead to more severe respiratory issues and other systemic symptoms. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506696-10-00Protocol codeGO45006Estimated enrolment1 150 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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