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The purpose of this study is to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin (PC) compared with atezolizumab matching placebo plus tiragolumab matching placebo plus PC as first-line treatment in participants with unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma (EC). Participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase:
Arm A: Atezolizumab plus Tiragolumab and PC Arm B: Atezolizumab placebo plus Tiragolumab placebo and PC Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab matching placebo plus tiragolumab matching placebo (Arm B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Tiragolumab + PC | Experimental | Participants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle during the study followed by paclitaxel and cisplatin on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the induction treatment phase. |
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| Placebo + PC | Placebo Comparator | Participants will receive atezolizumab matching placebo and tiragolumab matching placebo on Day 1 of each 21-day cycle during the study followed by paclitaxel and cisplatin on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the induction treatment phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab at a fixed dose of 1200 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. |
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| Measure | Description | Time Frame |
|---|---|---|
| Independent Review Facility (IRF)-Assessed Progression-Free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm). | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months) |
| Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. | From randomization to death from any cause (up to approximately 27 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-Assessed PFS | PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm). |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Anhui | 230001 | China | |||
| Anyang Tumor Hosptial |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41449151 | Derived | Sun JM, Chao Y, Kim SB, Rha SY, Evans TRJ, Strickland AH, Wainberg Z, Chau I, Pelles-Avraham S, Ajani J, Malhotra R, Liu Q, Li S, Cha E, Kalaitzidou M, Huang X, Allen S, Hsu CH. First-line tiragolumab plus atezolizumab and chemotherapy in patients with previously untreated, locally advanced unresectable or metastatic oesophageal cancer (MORPHEUS-EC): a randomised, open-label, phase 1b/2 trial. Lancet Oncol. 2026 Jan;27(1):90-102. doi: 10.1016/S1470-2045(25)00402-4. | |
| 41449142 |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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Overall, 461 participants were enrolled and randomized in the study with a 1:1 allocation ratio between treatment arms. Participants received the same drugs as induction and maintenance treatments except for chemotherapy.
Participants were recruited from 67 centers across 5 countries/regions in Asia: mainland China, Republic of Korea, Thailand, Taiwan and Hong Kong.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + PC | Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2023 | Feb 6, 2026 |
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| Tiragolumab | Drug | Tiragolumab at a fixed dose of 600 mg administered by IV infusion every Q3W on Day 1 of each 21-day cycle. |
|
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| Paclitaxel | Drug | Paclitaxel 175 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles. |
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| Cisplatin | Drug | Cisplatin 60-80 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles. |
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| Atezolizumab Matching Placebo | Drug | Atezolizumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle. |
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| Tiragolumab Matching Placebo | Drug | Tiragolumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle. |
|
| From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months) |
| IRF-Assessed Confirmed Objective Response Rate (ORR) | IRF- assessed confirmed ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by an IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR | From randomization up to approximately 19 months |
| Investigator-Assessed Confirmed ORR | Investigator-assessed confirmed ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR | From randomization up to approximately 19 months |
| IRF-Assessed Duration of Objective Response (DOR) | DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by an IRF according to RECIST v1.1. OR=CR+PR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm. | From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months) |
| Investigator-Assessed DOR | DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by the investigator according to RECIST v1.1. OR=CR+PR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm. | From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months) |
| Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning as Measured by EORTC QLQ-C30 | Clinically meaningful changes in physical functioning as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is 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) within the previous week. Physical functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by >/=10 points. | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months) |
| TTCD in Participant-Reported Role Functioning as Measured by EORTC QLQ-C30 | Clinically meaningful changes in role functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is 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) within the previous week. Functioning items were scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by >/=10 points. | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months) |
| TTCD in Participant-Reported Global Health Status (GHS)/Quality of Life (QoL) as Measured by EORTC QLQ-C30 | Clinically meaningful changes in GHS/QoL as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is 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) within the previous week. GHS and QoL items were scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better GHS/QoL. Participants were considered "Worsened" if their baseline score decreased by >/=10 points. | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months) |
| TTCD in Participant-Reported Dysphagia as Measured by EORTC Quality of Life-Esophageal Cancer, Module 18 Questionnaire (EORTC QLQ-OES18) | Clinically meaningful changes in dysphagia as measured by the EORTC QLQ-OES18. EORTC QLQ-OES18 is a modular supplement to the EORTC QLQ-C30 questionnaire for use in participants with esophageal cancer. EORTC QLQ-OES18 consisted of 4 multiple-item scale (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking) with a recall period of the previous week. Each symptom item was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms. Participants were considered "Worsened" if their baseline score increased by >/=10 points. | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 35 months) |
| Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Up to approximately 35 months |
| Minimum Serum Concentration (Cmin) of Tiragolumab | As indicated in the row titles of the table Cmin of Cycle 1 was measured predose at Cycle (C) 2 Day (D) 1. Cmin of Cycle 2 was measured predose at C3D1, etc. | Predose at on Day 1 of Cycles (cycle=21 days) 2, 3, 4, 8, 12, 16 |
| Maximum Serum Concentration (Cmax) of Tiragolumab | Cycle 1 (cycle=21 days), Day 1: 30 minutes postdose |
| Cmin of Atezolizumab | As indicated in the row titles of the table Cmin of Cycle 1 was measured predose at Cycle (C) 2 Day (D) 1. Cmin of Cycle 2 was measured predose at C3D1, etc. | Predose at on Day 1 of Cycles (cycle=21 days) 2, 3, 4, 8, 12, 16 |
| Cmax of Atezolizumab | Cycle 1 (cycle=21 days), Day 1: 30 minutes postdose |
| Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab | Participants were considered to be anti-drug antibody (ADA) positive if they were ADA negative or had missing data at Baseline but developed an ADA response following study drug exposure (i.e., treatment-induced ADA positive), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (i.e., treatment-enhanced ADA positive); these ADA positive responses are summarized together (induced + enhanced) in the 'treatment-emergent ADA positive' category. | Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 35 months) |
| Number of Participants Positive for ADAs to Atezolizumab | Participants were considered to be anti-drug antibody (ADA) positive if they were ADA negative or had missing data at Baseline but developed an ADA response following study drug exposure (i.e., treatment-induced ADA positive), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (i.e., treatment-enhanced ADA positive); these ADA positive responses are summarized together (induced + enhanced) in the 'treatment-emergent ADA positive' category. | Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 35 months) |
| Anyang |
| 455000 |
| China |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Beijing Luhe Hospital Capital Medical University | Beijing | China |
| the First Hospital of Jilin University | Changchun | 130021 | China |
| Jilin Cancer Hospital | Changchun | 132013 | China |
| Hunan Cancer Hospital | Changsha | 410013 | China |
| Affiliated Hospital of Chengde Medical University | Chengde | 067020 | China |
| Sichuan Provincial Cancer Hospital | Chengdu | 610041 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Chongqing Sanxia Central Hospital | Chongqing | 404000 | China |
| The First People's Hospital of Foshan | Foshan | 510000 | China |
| Fujian Cancer Hospital | Fuzhou | 350014 | China |
| Fujian Provincial Hospital | Fuzhou | China |
| Southern Medical University Nanfang Hospital | Guangdong Province Guangzhou City | 510515 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Anhui Province Cancer Hospital | Hefei | 12345 | China |
| The Second Affiliated Hospital of Anhui Medical University | Hefei | 230601 | China |
| Huai'an First People's Hospital | Huai'an | China |
| The Second People's Hospital of Huai'an | Huai'an | China |
| Affiliated Hopsital of Jining Medical University | Jining | China |
| Gansu Province People Hospital | Lanzhou | 730000 | China |
| The First People's Hospital of Lian Yun Gang | Lianyungang | 222002 | China |
| Linyishi Cancer Hospital | Linyi | 276034 | China |
| The First Affiliated Hospital to Henan University of Science and Technology | Luoyang | 471003 | China |
| Jiangsu Province Hospital of Chinese Medicine | Nanjing | 210029 | China |
| Jiangsu Cancer Hospital | Nanjing | 211100 | China |
| Nan Tong Tumor Hospital | Nantong | 226361 | China |
| Shanghai Chest Hospital | Shanghai | 200000 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Cancer Hospital of Shantou University Medical College | Shantou | 515041 | China |
| Liaoning Provincial Cancer Hospital | Shengyang | 110042 | China |
| Suining Central Hospital | Suining | 629000 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| Weifang People's Hospital | Weifang | China |
| Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology | Wuhan | 430022 | China |
| Hubei Cancer Hospital | Wuhan | 430079 | China |
| Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) | Wuxi | 214122 | China |
| The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital) | Xi'an | 710038 | China |
| First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an | 710061 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | 361003 | China |
| Zhongshan Hospital Xiamen University | Xiamen | 361004 | China |
| Xiangyang Central Hospital | Xiangyang | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | China |
| Xuzhou Central Hospital | Xuzhou | China |
| Northern Jangsu People's Hospital | Yangzhou | 225001 | China |
| Henan Cancer Hospital | Zhengzhou | 450008 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 450052 | China |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Prince of Wales Hosp | Shatin | Hong Kong |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13605 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Chang Gung Medical Foundation - Kaohsiung | Kaohisung | Taiwan |
| National Cheng Kung University Hospital | Tainan | 00704 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112201 | Taiwan |
| National Taiwan University Hospital | Zhongzheng Dist. | 10048 | Taiwan |
| Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Siriraj Hospital | Bangkok | 10700 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Derived |
| Hsu CH, Lu Z, Gao S, Wang J, Sun JM, Liu T, Fan Q, Cai J, Ge F, Li S, Zhang L, Cha E, Allen S, Shen L. Tiragolumab plus atezolizumab and chemotherapy as first-line treatment for patients with unresectable oesophageal squamous cell carcinoma (SKYSCRAPER-08): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 Jan;27(1):103-115. doi: 10.1016/S1470-2045(25)00401-2. |
| FG001 | Atezolizumab + Tiragolumab + PC | Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment. |
| Safety Population | All randomized participants who received any amount of study treatment |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + PC | Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity. |
| BG001 | Atezolizumab + Tiragolumab + PC | Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Independent Review Facility (IRF)-Assessed Progression-Free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm). | Full analysis set (FAS) included all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months) |
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| Primary | Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. | FAS included all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to death from any cause (up to approximately 27 months) |
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| Secondary | Investigator-Assessed PFS | PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by the investigator according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 millimeters (mm). | FAS included all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months) |
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| Secondary | IRF-Assessed Confirmed Objective Response Rate (ORR) | IRF- assessed confirmed ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as determined by an IRF according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR | FAS included all randomized participants regardless of whether they received any study treatment. Participants were classified as missing or not evaluable if no post-baseline response assessments were available or all post-baseline response assessments were not evaluable. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to approximately 19 months |
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| Secondary | Investigator-Assessed Confirmed ORR | Investigator-assessed confirmed ORR was defined as the percentage of participants with a complete response (CR) or a partial response (PR) as determined by the investigator according to RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. OR=CR+PR | FAS included all randomized participants regardless of whether they received any study treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | From randomization up to approximately 19 months |
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| Secondary | IRF-Assessed Duration of Objective Response (DOR) | DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by an IRF according to RECIST v1.1. OR=CR+PR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm. | FAS included all randomized participants regardless of whether they received any study treatment. DOR was assessed in participants who achieved a confirmed objective response, as determined by an IRF according to RECIST v1.1. | Posted | Median | 95% Confidence Interval | months | From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months) |
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| Secondary | Investigator-Assessed DOR | DOR was defined as the time from the first occurrence of a documented objective response (OR) to progressive disease (PD) or death from any cause (whichever occurred first) as determined by the investigator according to RECIST v1.1. OR=CR+PR. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of >/= 5 mm. | FAS included all randomized participants regardless of whether they received any study treatment. DOR was assessed in participants who achieved a confirmed objective response, as determined by the investigator according to RECIST v1.1. | Posted | Median | 95% Confidence Interval | months | From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months) |
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| Secondary | Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning as Measured by EORTC QLQ-C30 | Clinically meaningful changes in physical functioning as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is 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) within the previous week. Physical functioning was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by >/=10 points. | FAS included all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTCD in Participant-Reported Role Functioning as Measured by EORTC QLQ-C30 | Clinically meaningful changes in role functioning as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is 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) within the previous week. Functioning items were scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning. Participants were considered "Worsened" if their baseline score decreased by >/=10 points. | FAS included all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTCD in Participant-Reported Global Health Status (GHS)/Quality of Life (QoL) as Measured by EORTC QLQ-C30 | Clinically meaningful changes in GHS/QoL as measured by the EORTC QLQ-C30. EORTC QLQ-C30 is 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) within the previous week. GHS and QoL items were scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores were linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better GHS/QoL. Participants were considered "Worsened" if their baseline score decreased by >/=10 points. | FAS included all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 27 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTCD in Participant-Reported Dysphagia as Measured by EORTC Quality of Life-Esophageal Cancer, Module 18 Questionnaire (EORTC QLQ-OES18) | Clinically meaningful changes in dysphagia as measured by the EORTC QLQ-OES18. EORTC QLQ-OES18 is a modular supplement to the EORTC QLQ-C30 questionnaire for use in participants with esophageal cancer. EORTC QLQ-OES18 consisted of 4 multiple-item scale (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking) with a recall period of the previous week. Each symptom item was scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores were linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms. Participants were considered "Worsened" if their baseline score increased by >/=10 points. | FAS included all randomized participants regardless of whether they received any study treatment. | Posted | Median | 95% Confidence Interval | months | From randomization until the first confirmed clinically meaningful deterioration (up to approximately 35 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Not Posted | Aug 2026 | Up to approximately 35 months | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Minimum Serum Concentration (Cmin) of Tiragolumab | As indicated in the row titles of the table Cmin of Cycle 1 was measured predose at Cycle (C) 2 Day (D) 1. Cmin of Cycle 2 was measured predose at C3D1, etc. | Not Posted | Aug 2026 | Predose at on Day 1 of Cycles (cycle=21 days) 2, 3, 4, 8, 12, 16 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Serum Concentration (Cmax) of Tiragolumab | Not Posted | Aug 2026 | Cycle 1 (cycle=21 days), Day 1: 30 minutes postdose | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmin of Atezolizumab | As indicated in the row titles of the table Cmin of Cycle 1 was measured predose at Cycle (C) 2 Day (D) 1. Cmin of Cycle 2 was measured predose at C3D1, etc. | Not Posted | Aug 2026 | Predose at on Day 1 of Cycles (cycle=21 days) 2, 3, 4, 8, 12, 16 | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cmax of Atezolizumab | Not Posted | Aug 2026 | Cycle 1 (cycle=21 days), Day 1: 30 minutes postdose | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab | Participants were considered to be anti-drug antibody (ADA) positive if they were ADA negative or had missing data at Baseline but developed an ADA response following study drug exposure (i.e., treatment-induced ADA positive), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (i.e., treatment-enhanced ADA positive); these ADA positive responses are summarized together (induced + enhanced) in the 'treatment-emergent ADA positive' category. | Not Posted | Aug 2026 | Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 35 months) | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Positive for ADAs to Atezolizumab | Participants were considered to be anti-drug antibody (ADA) positive if they were ADA negative or had missing data at Baseline but developed an ADA response following study drug exposure (i.e., treatment-induced ADA positive), or if they were ADA positive at baseline and the titer of one or more postbaseline samples was at least 0.60 titer unit greater than the titer of the baseline sample (i.e., treatment-enhanced ADA positive); these ADA positive responses are summarized together (induced + enhanced) in the 'treatment-emergent ADA positive' category. | Not Posted | Aug 2026 | Predose on Day 1 of Cycles (cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 35 months) | Participants |
Up to approximately 27 months
Safety population included all randomized participants who received any amount of study treatment. All-cause mortality is reported for all randomized participants, whether or not the participant received the assigned treatment.
As per planned analysis AEs were to be collected per treatment arm and not per intervention received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + PC | Participants received atezolizumab matching placebo plus tiragolumab matching placebo in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e. atezolizumab matching placebo plus tiragolumab matching placebo on Day 1 of each 21-day cycle until, loss of clinical benefit or unacceptable toxicity. | 158 | 232 | 89 | 227 | 223 | 227 |
| EG001 | Atezolizumab + Tiragolumab + PC | Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment. | 129 | 229 | 94 | 228 | 225 | 228 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Autoimmune myocarditis | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypopituitarism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oesophagopleural fistula | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspergillus infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Lymph gland infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia necrotising | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Post procedural pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Anastomotic ulcer | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Foreign body in gastrointestinal tract | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Silicosis | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Coagulation test abnormal | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Immune-mediated myositis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute myelomonocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cerebrovascular disorder | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA 25.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acquired tracheo-oesophageal fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oesophagobronchial fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Autoimmune dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Immune-mediated dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood chloride decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2022 | Feb 6, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000730814 | Tiragolumab |
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
Not provided
Not provided
| Male |
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Atezolizumab + Tiragolumab + PC | Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment. |
|
|
| OG001 | Atezolizumab + Tiragolumab + PC | Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment. |
|
|
| OG001 | Atezolizumab + Tiragolumab + PC | Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment. |
|
|
|
| Atezolizumab + Tiragolumab + PC |
Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment. |
|
|
|
| Atezolizumab + Tiragolumab + PC |
Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment. |
|
|
|
| OG001 | Atezolizumab + Tiragolumab + PC | Participants received atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin on Day 1 of each 21-day cycle for 6 cycles as induction treatment followed by maintenance treatment with the same drugs i.e atezolizumab plus tiragolumab on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the maintenance treatment. |
|
|
|