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Study of Tiragolumab and Atezolizumab for Patients with Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Not Had 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 is investigating the effects of two medications, tiragolumab and atezolizumab, in patients who have not received chemotherapy before. Tiragolumab is an experimental drug, while atezolizumab is already used in some cancer treatments. The purpose of the study is to evaluate how well these medications work together compared to a combination of atezolizumab and a placebo.

Participants in the study will receive treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of time, during which participants will receive regular doses of the medications. The researchers will monitor the participants' health and the progression of their cancer to see how the treatment affects them. The study aims to understand the response rate, which is how well the cancer responds to the treatment, and progression-free survival, which is the length of time during and after treatment that the cancer does not get worse.

Throughout the study, the safety and any side effects of the medications will be closely observed. The researchers will also measure the levels of tiragolumab and atezolizumab in the blood at specific times to understand how the body processes these drugs. This study is important for finding new ways to treat NSCLC and could potentially lead to better treatment options for patients in the future.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that there has been no prior systemic treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC).

    Tumor PD-L1 expression is checked using previously obtained tumor tissue or a biopsy taken during screening. Availability of representative tumor specimens and a pathology report is confirmed.

    The presence of measurable disease is assessed according to specific criteria, and a life expectancy of at least 12 weeks is required. Adequate blood and organ function are also evaluated.

  2. Step 2

    Randomization and treatment assignment

    Participants are randomly assigned to receive either the combination of tiragolumab and atezolizumab or a placebo with atezolizumab. This process is blinded, meaning neither the participant nor the study team knows which treatment is being administered.

  3. Step 3

    Treatment administration

    Atezolizumab is administered as an intravenous (IV) infusion. The specific dosage and frequency are determined by the study protocol.

    Tiragolumab or its placebo is also given as an IV infusion. The dosage and frequency follow the study guidelines.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to assess the treatment's effectiveness and safety. This includes measuring the objective response rate (ORR) and progression-free survival (PFS).

    Secondary assessments include the duration of response (DOR), overall survival, and the incidence and severity of any adverse events.

    Regular checks of vital signs, physical findings, and laboratory results are performed to identify any significant changes from baseline.

    Blood samples may be taken at specified times to measure the levels of tiragolumab or atezolizumab and to check for any treatment-emergent anti-drug antibodies (ADAs).

  5. Step 5

    Study completion

    The study is expected to conclude by March 31, 2025. Participants will be informed of their treatment group and any relevant findings from the study.

Who can join the trial?

10 criteria

  • Must have **non-small cell lung cancer (NSCLC)**, which is a type of lung cancer.
  • Should not have received any previous **systemic treatment** for advanced lung cancer. Systemic treatment refers to medication that travels through the bloodstream to reach and affect cells all over the body.
  • The cancer must show **PD-L1 expression**. PD-L1 is a protein that can be found on cancer cells, and its presence is checked using a sample of the tumor tissue.
  • Must have a sample of the tumor available for testing, along with a report from a pathologist, who is a doctor that examines tissues to diagnose diseases.
  • Must have a **measurable disease** according to specific guidelines called RECIST v1.1, which are used to assess how well a treatment is working by measuring the size of tumors.
  • Must have a **life expectancy** of at least 12 weeks, meaning the doctor expects the patient to live for at least 12 more weeks.
  • Must have **adequate hematologic and end-organ function**, which means the blood and major organs like the liver and kidneys are working well enough.
  • Both men and women can participate.
  • Participants can be from certain age groups, typically adults.
  • People who are considered part of a **vulnerable population** may also be included. This term refers to groups who might need special protection or consideration in research.

Who cannot join the trial?

7 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 received certain treatments for cancer that might interfere with the study cannot participate.
  • Patients with serious health conditions that could affect their safety during the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with a history of severe allergic reactions to similar medications cannot participate.
  • Patients who are unable to follow the study procedures or attend study visits cannot participate.
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Investigated drugs

  • Tiragolumab

    is an experimental medication being studied for its potential to help the immune system fight cancer. It is an antibody that targets a specific protein called TIGIT, which can suppress the immune response. By blocking this protein, tiragolumab may enhance the body's ability to attack cancer cells.

  • Atezolizumab

    is a medication used to treat certain types of cancer by helping the immune system recognize and destroy cancer cells. It works by blocking a protein called PD-L1, which can prevent the immune system from attacking cancer cells. Atezolizumab is used in this trial to see if it can be more effective when combined with tiragolumab.

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 (NSCLC). It is an investigational medication, and its status in medical literature is primarily within the context of ongoing research. The main therapeutic indication for tiragolumab is in combination with atezolizumab for patients with locally advanced or metastatic NSCLC. At the molecular level, tiragolumab works by targeting the TIGIT protein, which is involved in immune regulation, thereby enhancing the body's immune response against 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 (NSCLC). It is well-documented in medical literature and is approved for use in several countries. The main therapeutic indication for atezolizumab is as a treatment for NSCLC, either alone or in combination with other medications like tiragolumab. 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 (NSCLC) – This is the most common type of lung cancer, accounting for about 85% of all cases. It typically grows and spreads more slowly than small cell lung cancer. NSCLC can be further classified into subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The disease often 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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508083-30-00Protocol codeGO40290Estimated enrolment135 patientsSponsorGenentech Inc.

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