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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

NCT04294810

Description:

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 NSCLC, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be in a randomized 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: GO41717
  • SECONDARY ID: 2019-002925-31
  • NCT ID: NCT04294810

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
AtezolizumabTecentriqPlacebo + Atezolizumab
TiragolumabMTIG7192ATiragolumab + Atezolizumab

Purpose

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 NSCLC, with no epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation. Eligible participants will be in a randomized 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.

Trial Arms

NameTypeDescriptionInterventions
Tiragolumab + AtezolizumabExperimentalParticipants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
  • Atezolizumab
  • Tiragolumab
Placebo + AtezolizumabPlacebo ComparatorParticipants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
  • Atezolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically or cytologically documented locally advanced or recurrent non-small
             cell lung cancer (NSCLC) not eligible for curative surgery and/or definitive
             chemoradiotherapy, or metastatic Stage IV non-squamous or squamous NSCLC

          -  No prior systemic treatment for metastatic NSCLC

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay

          -  Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1
             (RECIST v1.1)

          -  Adequate hematologic and end-organ function

        Exclusion Criteria:

          -  Known mutation in the EGFR gene or an anaplastic lymphoma kinase (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 prior to screening, 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-Free Survival (PFS)
Time Frame:From randomization up to disease progression or relapse or death (whichever occurs first), up to 59 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Confirmed Overall Response Rate (ORR)
Time Frame:From randomization up to disease progression or relapse or death (whichever occurs first), up to 59 months
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:From randomization up to disease progression or relapse or death (whichever occurs first), up to 59 months
Safety Issue:
Description:
Measure:PFS Rates at 6 Months and 12 Months
Time Frame:6 months, 12 months
Safety Issue:
Description:
Measure:OS Rates at 12 Months and 24 Months
Time Frame:12 months, 24 months
Safety Issue:
Description:
Measure:Time to Sustained Deterioration (TTSD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score
Time Frame:Up to 59 months
Safety Issue:
Description:TTSD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS) and physical functioning from baseline that must be held for all subsequent assessment timepoints or followed by death attributable to cancer progression. EORTC QLQ-C30: a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting and pain), GHS and quality of life (QoL), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) with a recall period of the previous week. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with higher score indicating worse outcome. Symptom items (GHS and QoL) are scored on a 7-point scale: 1=Very poor to 7=Excellent. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. Higher score indicates better outcome.
Measure:PFS in Participants With Programmed Death-Ligand 1 (PD-L1) Expression
Time Frame:From randomization up to disease progression or relapse or death (whichever occurs first), up to 59 months
Safety Issue:
Description:
Measure:OS in Participants With PD-L1 Expression
Time Frame:From randomization up to death of any cause, up to 59 months
Safety Issue:
Description:
Measure:Percentage of Participants With Adverse Events (AEs)
Time Frame:Up to 59 months
Safety Issue:
Description:
Measure:Minimum Serum Concentration (Cmin) of Tiragolumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at treatment discontinuation (TD) visit (up to 59 months)
Safety Issue:
Description:
Measure:Maximum Serum Concentration (Cmax) of Tiragolumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months)
Safety Issue:
Description:
Measure:Cmin of Atezolizumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months)
Safety Issue:
Description:
Measure:Cmax of Atezolizumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months)
Safety Issue:
Description:
Measure:Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab
Time Frame:Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months)
Safety Issue:
Description:
Measure:Percentage of Participants With ADAs to Atezolizumab
Time Frame:Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8,12 and 16 and at TD visit (up to 59 months)
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

March 2, 2020