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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 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.

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

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
Matching PlaceboPlacebo + 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 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.

Trial Arms

NameTypeDescriptionInterventions
Tiragolumab + AtezolizumabExperimentalParticipants will receive atezolizumab followed by tiragolumab every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
  • Atezolizumab
  • Tiragolumab
Placebo + AtezolizumabPlacebo ComparatorParticipants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity.
  • Atezolizumab
  • Matching Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  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

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

          -  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

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Investigator-Assessed Progression-Free Survival (PFS) in the Primary Population
Time Frame:From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Investigator-Assessed PFS in the Secondary Population
Time Frame:From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Safety Issue:
Description:
Measure:OS in the Secondary Population
Time Frame:From randomization to death from any cause (up to approximately 59 months)
Safety Issue:
Description:
Measure:Investigator-Assessed PFS in Participants With High Tumor Programmed Death-Ligand 1 (PD-L1) Expression
Time Frame:From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Safety Issue:
Description:
Measure:OS in Participants With High Tumor PD-L1 Expression
Time Frame:From randomization to death from any cause (up to approximately 59 months)
Safety Issue:
Description:
Measure:Investigator-Assessed Confirmed Objective Response Rate (ORR)
Time Frame:From randomization up to approximately 59 months
Safety Issue:
Description:
Measure:Investigator-Assessed Duration of Response (DOR)
Time Frame:From the first occurrence of a documented confirmed objective response to disease progression or death from any cause, whichever occurs first (up to approximately 59 months)
Safety Issue:
Description:
Measure:Investigator-Assessed 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 Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core (QLQ-C30) Score
Time Frame:From randomization until the first confirmed clinically meaningful deterioration (up to approximately 59 months)
Safety Issue:
Description:TTCD using EORTC QLQ-C30 is an initial 10-point decrease in global health status (GHS)/quality of life (QoL) and functioning from baseline that must be held for at least two consecutive assessments or an initial clinically meaningful decrease above baseline followed by death. 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 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:Percentage of Participants With Adverse Events (AEs)
Time Frame:Up to approximately 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 approximately 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 approximately 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 approximately 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 approximately 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 approximately 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 approximately 59 months)
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

February 2, 2021