Clinical Trials /

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

NCT04256421

Description:

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 randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase:- - Arm A: Tiragolumab plus atezolizumab and CE - Arm B: Placebo plus atezolizumab and CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

Related Conditions:
  • Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: GO41767
  • SECONDARY ID: 2019-003301-97
  • NCT ID: NCT04256421

Conditions

  • Small Cell Lung Cancer

Interventions

DrugSynonymsArms
TiragolumabMTIG7192ATiragolumab + Atezolizumab + CE
AtezolizumabTecentriqPlacebo + Atezolizumab + CE
CarboplatinPlacebo + Atezolizumab + CE
EtoposidePlacebo + Atezolizumab + CE
PlaceboPlacebo + Atezolizumab + CE

Purpose

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 randomized 1:1 to receive one of the following treatment regimens during induction phase:- - Arm A: Tiragolumab plus atezolizumab and CE - Arm B: Placebo plus atezolizumab and CE Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab plus placebo (Arm B).

Trial Arms

NameTypeDescriptionInterventions
Tiragolumab + Atezolizumab + CEExperimentalParticipants will receive atezolizumab on Day 1 of each 21-day cycle followed by tiragolumab on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.
  • Tiragolumab
  • Atezolizumab
  • Carboplatin
  • Etoposide
Placebo + Atezolizumab + CEActive ComparatorParticipants will receive atezolizumab on Day 1 of each 21-day cycle followed by placebo on Day 1 of each 21-day cycle. Carboplatin will be administered followed by etoposide on Day 1 for 4 cycles. Participants will also receive etoposide on Days 2 and 3.
  • Atezolizumab
  • Carboplatin
  • Etoposide
  • Placebo

Eligibility Criteria

        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 with therapeutic intent within 28 days
             prior to randomization

          -  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 randomization
      
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 to disease progression or death (whichever occurs first), up to 43 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Confirmed Objective Response Rate (ORR)
Time Frame:From randomization up to disease progression or relapse or death, whichever occurs first, up to 43 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 43 months
Safety Issue:
Description:
Measure:PFS Rates at 6 Months and 12 Months
Time Frame:6 months, 12 months
Safety Issue:
Description:
Measure:Overall Survival 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 43 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:Percentage of Participants With Adverse Events
Time Frame:Up to 43 months
Safety Issue:
Description:
Measure:Minimum Serum Concentration (Cmin) of Tiragolumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at treatment discontinuation (TD) visit (up to 43 months).
Safety Issue:
Description:
Measure:Cmin of Atezolizumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 43 months)
Safety Issue:
Description:
Measure:Maximum Serum Concentration (Cmax) of Tiragolumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 43 months)
Safety Issue:
Description:
Measure:Cmax of Atezolizumab
Time Frame:Predose and postdose on Day 1 of Cycle 1 (each cycle is 21 days) and predose on Day 1 of Cycles 2, 3, 4, 8,12 and 16 and at TD visit (up to 43 months)
Safety Issue:
Description:
Measure:Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab
Time Frame:Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 43 months)
Safety Issue:
Description:
Measure:Percentage of Participants With ADAs to Atezolizumab
Time Frame:Predose on Day 1 of Cycles 1 (each cycle is 21 days), 2, 3, 4, 8,12 and 16 and at TD visit (up to 43 months)
Safety Issue:
Description:

Details

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

Last Updated

February 6, 2020