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Study of Atezolizumab and Tiragolumab Compared to Durvalumab for Patients with Advanced Non-Small Cell Lung Cancer After Chemoradiation

Verified siteRegistered drugNo placebo
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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 effectiveness of two treatments: atezolizumab and tiragolumab, compared to another treatment called durvalumab. Atezolizumab is also known by its code name RO5541267, and durvalumab is known as MEDI4736. These treatments are given as solutions through an intravenous (IV) infusion, 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 atezolizumab and tiragolumab works compared to durvalumab in patients with locally advanced, unresectable stage III NSCLC. "Unresectable" means that the cancer cannot be removed with surgery. The study will look at how long patients live without the cancer getting worse, which is known as progression-free survival. This will be assessed by an independent review facility, which is a group of experts who will review the results.

Participants in the study will receive their assigned treatment for up to 52 weeks. The study will monitor the patients' health and the progression of their cancer during this time. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments. The study aims to provide valuable information on the best treatment options 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, the patient is confirmed to have non-small cell lung cancer (NSCLC) that is locally advanced and cannot be removed by surgery.

    The patient must have completed at least two cycles of platinum-based chemotherapy with radiotherapy, with no disease progression during or after this treatment.

  2. Step 2

    Randomization

    The patient is randomly assigned to one of the treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being studied.

  3. Step 3

    Treatment administration

    The patient receives treatment through an intravenous (IV) infusion. The specific medications used are either a combination of atezolizumab and tiragolumab or durvalumab alone.

    Atezolizumab is administered as Tecentriq 840 mg concentrate for solution for infusion.

    Durvalumab is administered as IMFINZI 50 mg/mL concentrate for solution for infusion.

    Tiragolumab is administered as a concentrate for solution for infusion.

  4. Step 4

    Monitoring and follow-up

    The patient's health and response to the treatment are regularly monitored. This includes assessments of disease progression and any side effects experienced.

    Progression-free survival (PFS) is evaluated, which measures the time during and after treatment that the patient lives with the disease without it getting worse.

  5. Step 5

    End of study participation

    The study is estimated to conclude by December 31, 2027. The patient's participation may end earlier if the disease progresses or if the patient experiences significant side effects.

Who can join the trial?

9 criteria

  • The patient must have **non-small cell lung cancer (NSCLC)**, which is a type of lung cancer.
  • The patient should have an **Eastern Cooperative Oncology Group Performance Status** of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The patient must have **NSCLC** that is locally advanced and cannot be removed by surgery, either of squamous or non-squamous type, confirmed by a tissue sample.
  • A **whole-body PET-CT scan** must be done for staging the cancer, within 42 days before starting the combined treatment of chemotherapy and radiotherapy.
  • The patient must have completed at least two cycles of **platinum-based chemotherapy** given at the same time as radiotherapy, finished between 1 to 42 days before joining the study. One cycle lasts 21 or 28 days.
  • The **radiotherapy** part of the treatment must have been given at a total dose of 60 Gy, with a possible variation of 10% (54 Gy to 66 Gy), using a method called **intensity-modulated radiotherapy** or a 3D-conforming technique.
  • The patient should not have experienced any worsening of the cancer during or after the combined treatment of chemotherapy and radiotherapy.
  • Both **male and female** patients can participate.
  • The study includes patients who might be considered vulnerable.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides non-small cell lung cancer (NSCLC) cannot participate. NSCLC is a type of lung cancer.
  • Patients who have previously received certain treatments that might interfere with the study drugs are not eligible.
  • Patients with serious heart conditions or uncontrolled high blood pressure cannot join the study.
  • Patients with active infections, such as hepatitis or HIV, are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to similar drugs are not eligible.
  • Patients with autoimmune diseases, where the immune system attacks the body, are excluded.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers, cannot join.
  • Patients with brain metastases, which are cancer cells that have spread to the brain, are not eligible unless treated and stable.
  • Patients who are unable to follow the study procedures or attend regular visits are excluded.
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Investigated drugs

  • Atezolizumab

    is a medication used in this trial to help the immune system fight cancer. It works by blocking a protein that can stop the immune system from attacking cancer cells, allowing the body to better target and destroy them.

  • Tiragolumab

    is another medication being tested in combination with atezolizumab. It is designed to enhance the immune response against cancer cells by targeting a specific protein that can inhibit immune activity, potentially improving the effectiveness of cancer treatment.

  • Durvalumab

    is a medication used as a comparison in this study. It also helps the immune system attack cancer cells by blocking a protein that prevents the immune system from working properly. This medication is used to see how well it works compared to the combination of atezolizumab and tiragolumab.

What is already known about the treatment

  • Atezolizumab

    Atezolizumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC). It is an approved medication in the field of oncology, with ongoing research to expand its use. The main therapeutic indication is for patients with locally advanced, unresectable stage III NSCLC who have not progressed after concurrent platinum-based chemoradiation. Atezolizumab works by blocking the interaction between PD-L1 and its receptors, PD-1 and B7.1, enhancing the immune system's ability to attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Tiragolumab

    Tiragolumab is administered intravenously and is currently under investigation in clinical trials for its potential to treat non-small cell lung cancer (NSCLC). It is not yet approved for general medical use but is being studied for its effectiveness in combination with atezolizumab. The main therapeutic indication is for patients with locally advanced, unresectable stage III NSCLC who have not progressed after concurrent platinum-based chemoradiation. Tiragolumab targets the TIGIT pathway, which is involved in immune suppression, thereby enhancing the immune response against cancer cells. It is classified as an immune checkpoint inhibitor.

  • Durvalumab

    Durvalumab is administered intravenously and is an approved medication used in the treatment of non-small cell lung cancer (NSCLC). It is being compared in clinical trials to assess its efficacy against other treatments. The main therapeutic indication is for patients with locally advanced, unresectable stage III NSCLC who have not progressed after concurrent platinum-based chemoradiation. Durvalumab works by blocking the PD-L1 protein, allowing the immune system to better recognize and destroy cancer cells. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Non-small cell lung cancer (NSCLC) – 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. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages 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.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502480-38-00Protocol codeGO41854Estimated enrolment829 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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