Clinical Trials List
Protocol NumberGO41854
NCT Number(ClinicalTrials.gov Identfier)NCT04513925
Active
2020-10-01 - 2027-12-31
Phase III
Not yet recruiting1
Recruiting2
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Phase III, Open-Label, Randomized Study of Atezolizumab and Tiragolumab Compared With Durvalumab in Patients With Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation
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Trial Applicant
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Sponsor
Hoffmann-La Roche
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 趙恒勝 Division of Thoracic Medicine
- 蕭慈慧 Division of Thoracic Medicine
- Chia-I Shen Division of Thoracic Medicine
- Chao-Hua Chiu Division of Thoracic Medicine
- Hsu-ching Huang Division of Thoracic Medicine
- YEN-HAN TSENG Division of Thoracic Medicine
- Chi-Lu Chiang Division of Thoracic Medicine
- Heng-Sheng Chao Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 吳尚俊 Division of General Internal Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- YEN-TING LIN Division of General Internal Medicine
- Chong-Jen Yu Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- James Chih-Hsin Yang Division of Hematology & Oncology
- 徐偉勛 醫學研究部
- 陳冠宇 Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- 錢穎群 Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- 廖斌志 Division of Hematology & Oncology
- 黃俊凱 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Yen Tu Division of General Internal Medicine
- Chia-Hsiang Li Division of General Internal Medicine
- 陳鴻仁 Division of General Internal Medicine
- Yu-Chao Lin Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer Who Have Not Progressed After Concurrent Platinum-Based Chemoradiation
Objectives
The purpose of this study is to evaluate the efficacy and safety of atezolizumab in combination with tiragolumab compared with durvalumab in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) who have received at least two cycles of concurrent platinum-based chemoradiotherapy (CRT) and have not had radiographic disease progression.
Test Drug
ATEZOLIZUMAB, TIRAGOLUMAB
Active Ingredient
ATEZOLIZUMAB
TIRAGOLUMAB
TIRAGOLUMAB
Dosage Form
injection
Dosage
840mg/14ml
600mg/10ml
600mg/10ml
Endpoints
Primary Outcome Measures :
Independent Review Facility (IRF) Assessed Progression Free Survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 90 months) ]
Secondary Outcome Measures :
Overall Survival (OS) [ Time Frame: From randomization to death from any cause (up to approximately 90 months) ]
Investigator-assessed PFS [ Time Frame: Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 90 months) ]
Confirmed Objective Response Rate (ORR) [ Time Frame: From randomization up to approximately 90 months ]
Duration of Response (DOR) [ Time Frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 90 months) ]
PFS Rates at 12 Months, 18 Months and 24 Months [ Time Frame: 12, 18 and 24 months ]
OS Rates at 12 Months, 24 Months, 36 Months and 48 Months [ Time Frame: 12, 24, 36 and 48 months ]
Time to Death or Distant Metastasis (TTDM) [ Time Frame: From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 90 months) ]
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: Up to approximatley 90 months ]
TTCD 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.
Percentage of Participants With Adverse Events [ Time Frame: Up to 90 approximately months ]
Serum Concentration of Tiragolumab [ Time Frame: Pre-dose and post-dose on Day 1 of Cycles 1 and 3 (cycle=28 days) and predose on Day 1 of Cycles 2, 4, 8, 10 and 12 and at treatment discontinuation (TD) visit (up to approximately 90 months) ]
Serum Concentration of Atezolizumab [ Time Frame: Pre-dose and post-dose on Day 1 of Cycle 1 (cycle=28 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 10 and 12 and at TD visit (up to approximately 90 months) ]
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [ Time Frame: Predose on Day 1 of Cycles 2, 3, 4, 8, 10 and 12 (cycle=28 days) and at TD visit (up to approximately 90 months) ]
Percentage of Participants With ADAs to Atezolizumab [ Time Frame: Predose on Day 1 of Cycles 2, 3, 4, 8, 10 and 12 (cycle=28 days) and at TD visit (up to approximately 90 months) ]
Independent Review Facility (IRF) Assessed Progression Free Survival (PFS) [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 90 months) ]
Secondary Outcome Measures :
Overall Survival (OS) [ Time Frame: From randomization to death from any cause (up to approximately 90 months) ]
Investigator-assessed PFS [ Time Frame: Time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first first (up to approximately 90 months) ]
Confirmed Objective Response Rate (ORR) [ Time Frame: From randomization up to approximately 90 months ]
Duration of Response (DOR) [ Time Frame: From first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 90 months) ]
PFS Rates at 12 Months, 18 Months and 24 Months [ Time Frame: 12, 18 and 24 months ]
OS Rates at 12 Months, 24 Months, 36 Months and 48 Months [ Time Frame: 12, 24, 36 and 48 months ]
Time to Death or Distant Metastasis (TTDM) [ Time Frame: From randomization until the first date of distant metastasis or death in the absence of distant metastasis (up to approximately 90 months) ]
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: Up to approximatley 90 months ]
TTCD 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.
Percentage of Participants With Adverse Events [ Time Frame: Up to 90 approximately months ]
Serum Concentration of Tiragolumab [ Time Frame: Pre-dose and post-dose on Day 1 of Cycles 1 and 3 (cycle=28 days) and predose on Day 1 of Cycles 2, 4, 8, 10 and 12 and at treatment discontinuation (TD) visit (up to approximately 90 months) ]
Serum Concentration of Atezolizumab [ Time Frame: Pre-dose and post-dose on Day 1 of Cycle 1 (cycle=28 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 10 and 12 and at TD visit (up to approximately 90 months) ]
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Tiragolumab [ Time Frame: Predose on Day 1 of Cycles 2, 3, 4, 8, 10 and 12 (cycle=28 days) and at TD visit (up to approximately 90 months) ]
Percentage of Participants With ADAs to Atezolizumab [ Time Frame: Predose on Day 1 of Cycles 2, 3, 4, 8, 10 and 12 (cycle=28 days) and at TD visit (up to approximately 90 months) ]
Inclution Criteria
Inclusion Criteria:
Patients must meet the following criteria for study entry:
Signed Informed Consent Form
Age 18 years at time of signing Informed Consent Form
Ability to comply with the study protocol, including willingness to remain in the post-treatment period
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (CRT)
At least two prior cycles of platinum-based chemotherapy concurrent with radiotherapy (cCRT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
No progression during or following concurrent platinum-based CRT
Tumor PD-L1 expression
Life expectancy >/= 12 weeks
Adequate hematologic and end-organ function
Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab
Patients must meet the following criteria for study entry:
Signed Informed Consent Form
Age 18 years at time of signing Informed Consent Form
Ability to comply with the study protocol, including willingness to remain in the post-treatment period
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Histologically or cytologically documented NSCLC with locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology
Whole-body Positron Emission Tomography-Computed Tomography (PET-CT) scan, performed prior and within 42 days of the first dose of concurrent chemoradiotherapy (CRT)
At least two prior cycles of platinum-based chemotherapy concurrent with radiotherapy (cCRT), which must be completed within 1 to 42 days prior to randomization in the study (one cycle of cCRT is defined as 21 or 28 days)
The radiotherapy (RT) component in the cCRT must have been at a total dose of radiation of 60 (±10 percent [%]) gray (Gy) (54 Gy to 66 Gy) administered by intensity modulated RT (preferred) or 3D-conforming technique
No progression during or following concurrent platinum-based CRT
Tumor PD-L1 expression
Life expectancy >/= 12 weeks
Adequate hematologic and end-organ function
Female participants must be willing to avoid pregnancy for 90 days after the final dose of tiragolumab and 5 months after the final dose of atezolizumab, or for 3 months after the final dose of durvalumab
Male participants must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab
Male participants must not donate sperm during the treatment period and for 90 days after the final dose of tiragolumab
Exclusion Criteria
Exclusion Criteria:
Any history of prior NSCLC
NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
Any evidence of Stage IV disease
Treatment with sequential CRT for locally advanced NSCLC
Participants with locally advanced NSCLC who have progressed during or after the definitive concurrent CRT prior to randomization
Any Grade >2 unresolved toxicity from previous CRT
Grade >= 2 pneumonitis from prior CRT
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
History of malignancy other than NSCLC within 5 years prior to screening
Prior allogeneic stem cell or solid organ transplantation
Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
Treatment with systemic immunosuppressive medication
Women who are pregnant, or breastfeeding
Any history of prior NSCLC
NSCLC known to have a mutation in the epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) fusion oncogene
Any evidence of Stage IV disease
Treatment with sequential CRT for locally advanced NSCLC
Participants with locally advanced NSCLC who have progressed during or after the definitive concurrent CRT prior to randomization
Any Grade >2 unresolved toxicity from previous CRT
Grade >= 2 pneumonitis from prior CRT
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
History of malignancy other than NSCLC within 5 years prior to screening
Prior allogeneic stem cell or solid organ transplantation
Active Epstein-Barr virus (EBV) infection or known or suspected chronic active EBV infection at screening
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-cytotoxic T lymphocyte-associated protein 4, anti-T-cell immunoreceptor with Ig and ITIM domains (anti-TIGIT), anti-PD-1 and anti-PD-L1
Any prior Grade >/= 3 immune-mediated adverse event or any unresolved Grade > 1 immune-mediated adverse event while receiving any previous immunotherapy agent other than immune checkpoint blockade agents
Treatment with systemic immunosuppressive medication
Women who are pregnant, or breastfeeding
The Estimated Number of Participants
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Taiwan
20 participants
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Global
800 participants
