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Study of Tiragolumab, Atezolizumab, and Pembrolizumab for Patients with Advanced Non-Squamous 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 treatments for a type of lung cancer known as non-squamous non-small cell lung cancer (NSCLC). The study involves several medications, including Tiragolumab, Atezolizumab, Pembrolizumab (also known by its code name MK-3475), and chemotherapy drugs Pemetrexed and Carboplatin/Cisplatin. The purpose of the study is to evaluate the effectiveness of these treatments in patients who have not received prior treatment for their advanced lung cancer.

Participants in the study will be randomly assigned to one of two groups. One group will receive a combination of Tiragolumab and Atezolizumab along with Pemetrexed and Carboplatin/Cisplatin. The other group will receive Pembrolizumab with Pemetrexed and Carboplatin/Cisplatin. Some participants may receive a placebo instead of Tiragolumab. The study will monitor how well the cancer responds to these treatments and how long patients live without the cancer getting worse.

The trial will take place over a period of time, with regular assessments to check the progress of the disease and the overall health of the participants. The study aims to provide valuable information on the best treatment options for patients with this type of lung cancer, focusing on improving survival rates and quality of life. Participants will receive their treatments through an intravenous infusion, which means the medication is given directly into a vein.

The research process

The trial runs in 6 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 the performance status, tumor characteristics, and previous treatment history.

    Tests are performed to ensure the absence of active infections such as HIV, hepatitis B, and hepatitis C.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. This process is double-blind, meaning neither the participant nor the healthcare provider knows which group the participant is in.

  3. Step 3

    Treatment administration

    Participants in the first group receive tiragolumab and atezolizumab in combination with pemetrexed and either carboplatin or cisplatin. These medications are administered through an intravenous infusion.

    Participants in the second group receive pembrolizumab in combination with pemetrexed and either carboplatin or cisplatin. These medications are also administered through an intravenous infusion.

  4. Step 4

    Treatment schedule

    The treatment is given in cycles. Each cycle lasts for a specified period, during which the medications are administered according to the study protocol.

  5. Step 5

    Monitoring and assessments

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and other evaluations to measure the size of the tumor and check for any progression of the disease.

    Participants are also monitored for any side effects or adverse reactions to the treatment.

  6. Step 6

    Follow-up

    After completing the treatment cycles, participants enter a follow-up phase. This involves periodic assessments to monitor long-term outcomes and overall survival.

    The follow-up phase continues until the end of the study or until the participant withdraws from the study.

Who can join the trial?

8 criteria

  • The patient must have a **Performance Status** of 0 or 1 according to the **Eastern Cooperative Oncology Group (ECOG)**. This means the patient should be fully active or have some symptoms but still be able to carry out light work.
  • The patient must have **non-squamous non-small cell lung cancer (NSCLC)** that is locally advanced, cannot be removed by surgery, or has spread to other parts of the body. The cancer should not be treatable with surgery or combined chemotherapy and radiation aimed at curing it.
  • The patient should not have received any previous treatment that affects the whole body for their metastatic non-squamous NSCLC.
  • The patient's tumor must have a known **PD-L1 status**. PD-L1 is a protein that can affect how the immune system responds to cancer.
  • The patient must have a **measurable disease** as defined by specific criteria called **RECIST v1.1**. This means the cancer can be measured in size to see if it changes during treatment.
  • The patient must have a negative **HIV test** and tests showing no active **hepatitis B** or **hepatitis C** infections at the time of screening.
  • The study is open to both male and female patients.
  • The study includes patients who are considered part of a vulnerable population, meaning they may need special protection or consideration.

Who cannot join the trial?

10 criteria

  • Patients with a different type of lung cancer than non-squamous non-small cell lung cancer (NSCLC) cannot participate. This means if you have a type of lung cancer that is not NSCLC, you are not eligible.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for participants within certain age groups.
  • Patients who are not able to follow the study procedures or who have conditions that make it unsafe for them to participate cannot join the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, may not be eligible to participate.
  • Patients who have other medical conditions that could interfere with the study or make it unsafe for them to participate cannot join.
  • Patients who are currently participating in another clinical trial or have recently participated in one may not be eligible.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have had a recent major surgery or have not fully recovered from a previous surgery may not be eligible.
  • Patients who have a history of severe allergic reactions to any of the study drugs or similar drugs cannot participate.
  • Patients who have an active infection or other serious medical condition that could interfere with the study cannot join.
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Investigated drugs

  • Tiragolumab

    is an investigational medication being studied for its potential to enhance the immune system's ability to fight cancer. It is used in combination with other cancer treatments to see if it can improve outcomes for patients with advanced non-squamous non-small-cell lung cancer.

  • Atezolizumab

    is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used in combination with other medications to treat certain types of lung cancer.

  • Pemetrexed

    is a chemotherapy drug that works by interfering with the growth of cancer cells. It is often used in combination with other drugs to treat non-small-cell lung cancer.

  • Carboplatin

    is a chemotherapy medication that helps to stop the growth of cancer cells. It is commonly used in combination with other drugs to treat various types of cancer, including lung cancer.

  • Cisplatin

    is another chemotherapy drug that works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is used in combination with other treatments for lung cancer.

  • Pembrolizumab

    is an immunotherapy drug that helps the immune system detect and fight cancer cells. It is used in combination with other medications to treat advanced non-small-cell lung cancer.

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-squamous non-small cell lung cancer (NSCLC). It is being evaluated for its effectiveness when combined with other medications like atezolizumab, pemetrexed, and carboplatin or cisplatin. Tiragolumab works by targeting and inhibiting a specific protein involved in immune regulation, which may enhance the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.

  • Atezolizumab

    Atezolizumab is given through intravenous infusion and is an established medication in the treatment of various cancers, including non-squamous non-small cell lung cancer (NSCLC). It is used in combination with other drugs like tiragolumab, pemetrexed, and carboplatin or cisplatin in clinical trials. Atezolizumab functions by blocking a protein that prevents the immune system from attacking cancer cells, thereby boosting the immune response. It belongs to the class of immune checkpoint inhibitors.

  • Pemetrexed

    Pemetrexed is administered intravenously and is widely used in the treatment of non-squamous non-small cell lung cancer (NSCLC). It is often combined with other chemotherapy agents such as carboplatin or cisplatin. Pemetrexed works by interfering with the cancer cell's ability to replicate its DNA, which is essential for cell division and growth. It is classified as an antimetabolite chemotherapy drug.

  • Carboplatin

    Carboplatin is given by intravenous infusion and is a well-established chemotherapy drug used in the treatment of various cancers, including non-squamous non-small cell lung cancer (NSCLC). It is often used in combination with other drugs like pemetrexed. Carboplatin works by damaging the DNA of cancer cells, which prevents them from dividing and growing. It is classified as a platinum-based chemotherapy agent.

  • Cisplatin

    Cisplatin is administered intravenously and is a commonly used chemotherapy drug for treating various types of cancer, including non-squamous non-small cell lung cancer (NSCLC). It is often used in combination with other medications such as pemetrexed. Cisplatin functions by forming cross-links in DNA, which disrupts the DNA structure and inhibits cancer cell division. It is classified as a platinum-based chemotherapy agent.

  • Pembrolizumab

    Pembrolizumab is administered through intravenous infusion and is an approved medication for treating several types of cancer, including non-squamous non-small cell lung cancer (NSCLC). It is being studied in combination with other drugs like pemetrexed and carboplatin or cisplatin. Pembrolizumab works by blocking a protein that inhibits the immune system from attacking cancer cells, thereby enhancing the immune response. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Non-squamous non-small cell lung cancer (NSCLC) – This is a type of lung cancer that does not involve the squamous cells, which are flat cells lining the airways. It is one of the most common types of lung cancer and typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the outer parts of 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 can 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 IVTrial ID2022-502031-20-00Protocol codeBO42592Estimated enrolment500 patientsSponsorF. Hoffmann-La Roche AG

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