A clinical trial to compare tiragolumab plus atezolizumab with placebo plus atezolizumab in people with untreated advanced non-small cell lung cancer.

A Study of Tiragolumab in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

  • Non-Small Cell Lung Cancer
Trial Status:

Recruiting

This trial runs in
Cities
  • 's-Hertogenbosch
  • Aalborg
  • Adana
  • Alacant
  • Ankara
  • Arequipa
  • Athens
  • Avellino
  • Badalona
  • Barcelona
  • Basel
  • Beograd
  • Bern
  • Budapest
  • cascina-perseghetto
  • Cercado de Lima
  • cheongju
  • Chuo City
  • Ciudad de México
  • Darlinghurst
  • Den Haag
  • Dnipropetrovs'k
  • Ede
  • Fairfax
  • Frankfurt am Main
  • Frankston
  • Fukuoka
  • Gdańsk
  • Großhansdorf
  • Gwangju
  • Gyöngyös
  • Halle (Saale)
  • Heidelberg
  • Immenhausen
  • Ina
  • Incheon
  • İstanbul
  • Ivano-Frankivs'k
  • İzmir
  • Kaohsiung City
  • Kashiwa
  • Kho Hong
  • Koto City
  • Krung Thep Maha Nakhon
  • Kryvyi Rih
  • Larisa
  • Lausanne
  • Leeuwarden
  • Linz
  • Littleton
  • Lombardia
  • Löwenstein
  • Madrid
  • Majadahonda
  • Malatya
  • Melbourne
  • Monterrey
  • Monza
  • Moscow
  • Moscow Oblast
  • Málaga
  • Münster
  • Nagaizumi
  • Nagoya
  • Napoli
  • Nashville
  • New Haven
  • Niigata
  • Okayama
  • Olsztyn
  • Osakasayama
  • Otwock
  • Padova
  • Perugia
  • Pireas
  • Poznań
  • Rio Grande do Sul
  • Roma
  • Roskilde
  • Saint Paul
  • Sakai
  • Salem
  • San Isidro
  • Sanatorio San Luigi
  • Sankt-Peterburg
  • Santiago de Querétaro
  • Sendai
  • Seongnam-si
  • Seoul
  • Sevilla
  • Sremska Kamenica
  • St. Gallen
  • St. Petersburg
  • Stuttgart
  • Surquillo
  • Suwon
  • Suwon-si
  • Szolnok
  • Taichung City
  • Tainan City
  • Taipei City
  • Tallahassee
  • Taoyuan City
  • Uzhhorod
  • Vancouver
  • Wels
  • Wien
  • Woolloongabba
  • Zaragoza
Trial Identifier:

NCT04294810 2019-002925-31 GO41717

      Show trial locations

      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

      Results Disclaimer

      Trial Summary

      The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04294810 , GO41717 , 2019-002925-31 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      How does the GO41717 clinical trial work?
      This clinical trial is recruiting people who have a type of disease called non-small cell lung cancer (NSCLC). In order to take part, patients must have advanced has spread to other parts of the body).

      The purpose of this clinical trial is to compare the effects, good or bad, of tiragolumab plus atezolizumab against placebo plus atezolizumab in patients with NSCLC. If you take part in this clinical trial, you will receive either tiragolumab plus atezolizumab or a placebo plus atezolizumab.

      How do I take part in this clinical trial?
      To be able to take part in this clinical trial, you must have been diagnosed with advanced or metastatic NSCLC.

      You must not have received previous treatment for advanced or metastatic NSCLC and you cannot join the trial if you are pregnant or breastfeeding.

      If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

      You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

      Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

      While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.

      What treatment will I be given if I join this clinical trial?
      Everyone who joins this clinical trial will be split into 2 groups randomly (like flipping a coin) and given either:

      • Tiragolumab plus atezolizumab given as infusions into the vein every 3 weeks
      • OR placebo plus atezolizumab, given as infusions into the vein every 3 weeks

      You will have an equal chance of being placed in either group.

      This is a ‘placebo-controlled’ clinical trial, which means that one of the groups will be given medicine with no active ingredients (also known as a ‘placebo’). A placebo is used to show that the doctor or the patients do not sway the results of the clinical trial.

      Neither you nor your clinical trial doctor can choose or know the group you are in. However, your clinical trial doctor can find out which group you are in, if your safety is at risk.

      How often will I be seen in follow-up appointments and for how long?
      During this study, you will come in for visits approximately every 3 weeks while you are receiving treatment.

      You will continue to receive study treatment on a regular basis unless your cancer worsens or if your doctor determines there is no benefit of continuing treatment.  After your final dose, your study doctor will follow up with you about every 3 months for as long as you agree to it.  Your total time in the study will depend on how your SCLC responds to treatment.  This could range from 1 day to more than 12 months.

      What happens if I am unable to take part in this clinical trial?
      If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

      For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov 

      Trial-identifier: NCT04294810

      Trial Summary

      The purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04294810 , GO41717 , 2019-002925-31 Trial Identifier
      Atezolizumab, Tiragolumab, Matching Placebo Treatments
      Non-Small Cell Lung Cancer Condition
      Official Title

      A Phase III, Randomized, Double-Blinded, Placebo-Controlled Study of Tiragolumab, an Anti-Tigit Antibody, in Combination With Atezolizumab Compared With Placebo in Combination With Atezolizumab in Patients With Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected Non-Small Cell Lung Cancer

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
      • Histologically or cytologically documented locally advanced or recurrent NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC
      • No prior systemic treatment for metastatic NSCLC
      • High tumor tissue PD-L1 expression
      • Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
      • Adequate hematologic and end-organ function
      • For participants enrolled in the extended China enrollment phase: current resident of mainland China or Taiwan and of Chinese ancestry.
      Exclusion Criteria
      • Known mutation in the EGFR gene or an ALK fusion oncogene
      • Symptomatic, untreated, or actively progressing central nervous system metastases
      • Active or history of autoimmune disease or immune deficiency
      • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
      • Malignancies other than NSCLC within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
      • Severe infection within 4 weeks prior to initiation of study treatment
      • Positive test result for human immunodeficiency virus (HIV)
      • Active hepatitis B or hepatitis C
      • Treatment with investigational therapy within 28 days prior to initiation of study treatment
      • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
      • Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.

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