Clinical Trials List
Protocol NumberGO41767
NCT Number(ClinicalTrials.gov Identfier)NCT04256421
Active
2020-01-01 - 2026-12-31
Phase III
Recruiting3
Terminated2
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, 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
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Trial Applicant
-
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
- Hsu-ching Huang Division of Thoracic Medicine
- Chi-Lu Chiang Division of Thoracic Medicine
- Heng-Sheng Chao Division of Thoracic Medicine
- Yung-Hung Luo Division of Thoracic Medicine
- 蕭慈慧 Division of Thoracic Medicine
- 趙恒勝 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 楊景堯 Division of General Internal Medicine
- Chia-Chi Lin Division of Hematology & Oncology
- 徐偉勛 Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 吳尚俊 Division of General Internal Medicine
- 林宗哲 Division of Hematology & Oncology
- Chong-Jen Yu 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
- 陳冠宇 Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wen-Pin Su Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
- Po-Lan Su Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
- Jui-Hung Tsai Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林定佑 Division of Hematology & Oncology
- Chih-Hsi Kuo Division of Hematology & Oncology
- Chien-Ying Liu Division of Hematology & Oncology
- 吳教恩 Division of Hematology & Oncology
- 邱立忠 Division of Hematology & Oncology
- Chih-Hung Chen Division of Hematology & Oncology
- 枋岳甫 Division of Hematology & Oncology
- Wen-Cheng Chang Division of Hematology & Oncology
- Cheng-Ta Yang Division of Hematology & Oncology
- Shih-Hong Li Division of Hematology & Oncology
- 柯皓文 Division of Hematology & Oncology
- 黃宗楨 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Untreated Extensive-Stage Small Cell Lung Cancer
Objectives
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).
Test Drug
TIRAGOLUMAB、ATEZOLIZUMAB、CARBOPLATIN、ETOPOSIDE
Active Ingredient
Atezolizumab
Carboplatin
Etoposide
Tiragolumab
Carboplatin
Etoposide
Tiragolumab
Dosage Form
IV
IV
IV
IV
IV
IV
IV
Dosage
600mg/10ml
1200mg/20ml
10
100mg/5ml
1200mg/20ml
10
100mg/5ml
Endpoints
Primary Outcome Measures :
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 50 months) ]
Overall Survival (OS) in the Primary Population [ Time Frame: From randomization to death from any cause (up to 50 months) ]
Secondary Outcome Measures :
PFS in the Intent-To-Treat (ITT) Population [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months) ]
OS in the ITT Population [ Time Frame: From randomization to death from any cause (up to 50 months) ]
Investigator-Assessed Confirmed Objective Response Rate (ORR) in the Primary Population [ Time Frame: From randomization up to 50 months ]
Investigator-Assessed Confirmed ORR in the ITT Population [ Time Frame: From randomization up to 50 months ]
Investigator-Assessed Duration of Response (DOR) in the Primary Population [ 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 50 months) ]
Investigator-Assessed DOR in the ITT Population [ 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 50 months) ]
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the Primary Population [ Time Frame: 6 months, 12 months ]
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the ITT Population [ Time Frame: 6 months, 12 months ]
Overall Survival Rates at 12 Months and 24 Months in the Primary Population [ Time Frame: 12 months, 24 months ]
Overall Survival Rates at 12 Months and 24 Months in the ITT Population [ Time Frame: 12 months, 24 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 in the Primary Population [ Time Frame: From randomization until the first confirmed clinically meaningful deterioration up to 50 months ]
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.
TTCD Assessed Using EORTC QLQ-C30 Score in the ITT Population [ Time Frame: From randomization until the first confirmed clinically meaningful deterioration up to 50 months ]
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.
Percentage of Participants With Adverse Events [ Time Frame: Up to 50 months ]
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 50 months). ]
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 50 months) ]
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 50 months) ]
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 50 months) ]
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 50 months) ]
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 50 months) ]
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 50 months) ]
Overall Survival (OS) in the Primary Population [ Time Frame: From randomization to death from any cause (up to 50 months) ]
Secondary Outcome Measures :
PFS in the Intent-To-Treat (ITT) Population [ Time Frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to 50 months) ]
OS in the ITT Population [ Time Frame: From randomization to death from any cause (up to 50 months) ]
Investigator-Assessed Confirmed Objective Response Rate (ORR) in the Primary Population [ Time Frame: From randomization up to 50 months ]
Investigator-Assessed Confirmed ORR in the ITT Population [ Time Frame: From randomization up to 50 months ]
Investigator-Assessed Duration of Response (DOR) in the Primary Population [ 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 50 months) ]
Investigator-Assessed DOR in the ITT Population [ 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 50 months) ]
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the Primary Population [ Time Frame: 6 months, 12 months ]
Investigator-Assessed PFS Rates at 6 Months and 12 Months in the ITT Population [ Time Frame: 6 months, 12 months ]
Overall Survival Rates at 12 Months and 24 Months in the Primary Population [ Time Frame: 12 months, 24 months ]
Overall Survival Rates at 12 Months and 24 Months in the ITT Population [ Time Frame: 12 months, 24 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 in the Primary Population [ Time Frame: From randomization until the first confirmed clinically meaningful deterioration up to 50 months ]
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.
TTCD Assessed Using EORTC QLQ-C30 Score in the ITT Population [ Time Frame: From randomization until the first confirmed clinically meaningful deterioration up to 50 months ]
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.
Percentage of Participants With Adverse Events [ Time Frame: Up to 50 months ]
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 50 months). ]
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 50 months) ]
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 50 months) ]
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 50 months) ]
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 50 months) ]
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 50 months) ]
Inclution 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
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
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-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
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-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
The Estimated Number of Participants
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Taiwan
25 participants
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Global
400 participants
