A Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

  • Small Cell Lung Cancer
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • Serbia
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey
  • United Kingdom
  • United States
Trial Identifier:

NCT04256421 2019-003301-97 GO41767

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      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

      This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (</= upper limit of normal [ULN] vs. > ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: - Arm A: Tiragolumab plus atezolizumab plus CE - Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04256421 , GO41767 , 2019-003301-97 Trial Identifier
      All Gender
      ≥18 Years Age
      No Healthy Volunteers

      1. HOW DOES THE GO41767 CLINICAL TRIAL WORK?   

      This clinical trial is recruiting people who have a type of disease called small cell lung cancer  (SCLC) that has spread to other parts of the body (called ‘extensive stage’ or ES-SCLC).  

      The purpose of this clinical trial is to compare the effects, good or bad, of atezolizumab plus  platinum-based chemotherapy (the current standard of care) against atezolizumab plus  platinum-based chemotherapy plus tiragolumab (the study drug). If you take part in this clinical  trial, you will receive either atezolizumab plus platinum-based chemotherapy plus a placebo  OR atezolizumab plus platinum-based chemotherapy plus tiragolumab.  

      2. HOW DO I TAKE PART IN THIS CLINICAL TRIAL?  

      To be able to take part in this clinical trial, you must have ES-SCLC that has spread to other  parts of the body. You must not have previously received any treatment for your ES-SCLC. 

      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 the information you need to  make a 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 and for up to 6 months after your final treatment, both men  and women (if you are not currently pregnant but can become pregnant) will need to either not  have heterosexual intercourse or must take contraceptive medication for safety reasons.  


      3. 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 receive the standard treatment (atezolizumab plus chemotherapy) with or  without tiragolumab. 

      Treatment will be given in 2 parts or ‘phases’: the induction phase and then the  maintenance phase. 

      Induction phase   

      • Atezolizumab, given as an infusion into the vein once every 3 weeks for 4 treatment cycles 
      • Tiragolumab (Group 1) OR placebo (Group 2), given as an infusion into the vein once every 3 weeks for 4 treatment cycles Chemotherapy  
      • Carboplatin given as an infusion into the vein once every 3 weeks for 4 treatment cycles  
      • Etoposide given as an infusion into the vein on Day 1, 2 and 3 every 3 weeks for 4 treatment cycles  

      Maintenance phase   

      • Atezolizumab plus tiragolumab, given as an infusion into the vein once every 3 weeks (Group 1)
      • OR atezolizumab plus placebo, given as an infusion into the vein once every 3 weeks (Group 2)

      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’) along with the current standard  of care of atezolizumab plus platinum-based chemotherapy. 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. 


      4. 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.

      5. 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: NCT04256421
        

      Trial Summary

      This study will evaluate the efficacy of tiragolumab plus atezolizumab and carboplatin and etoposide (CE) compared with placebo plus atezolizumab and CE in participants with chemotherapy-naive extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be stratified by Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), LDH (</= upper limit of normal [ULN] vs. > ULN), and presence or history of brain metastasis (yes vs. no) and randomly assigned in a 1:1 ratio to receive one of the following treatment regimens during induction phase: - Arm A: Tiragolumab plus atezolizumab plus CE - Arm B: Placebo plus atezolizumab plus CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT04256421 , GO41767 , 2019-003301-97 Trial Identifier
      Tiragolumab, Atezolizumab, Carboplatin, Etoposide, Placebo Treatments
      Small Cell Lung Cancer Condition
      Official Title

      A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab (Anti-Tigit Antibody) in Patients With Untreated Extensive-Stage Small Cell Lung Cancer

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
      • No prior systemic treatment for ES-SCLC
      • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
      • Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
      • Adequate hematologic and end-organ function
      • Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC
      Exclusion Criteria
      • Symptomatic or actively progressing central nervous system (CNS) metastases
      • Malignancies other than small cell lung cancer (SCLC) within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
      • 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 on screening chest computed tomography (CT) scan
      • Positive test result for human immunodeficiency virus (HIV)
      • Active hepatitis B or hepatitis C
      • Severe infection at the time of randomization
      • Treatment with any other investigational agent within 28 days prior to initiation of study treatment
      • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-cytotoxic T lymphocyte-associated protein 4 (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 randomization

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