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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-506696-10-00 | Registry Identifier | EU CT |
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Decision to terminate study was driven by results from preceding tiragolumab study (SKYSCRAPER-06;NCT04619797) & sponsor's strategic priorities, not due to safety risks or quality reasons for any of molecules/combinations investigated in this study.
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The purpose of this study was to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab administered to participants with non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy.
With Protocol Amendment 2, enrollment will be stopped. The primary objective of the study has been changed to a safety objective and no other analysis will be conducted
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Tiragolumab | Experimental | Participants will receive atezolizumab and tiragolumab intravenously (IV). |
|
| Atezolizumab + Placebo | Placebo Comparator | Participants will receive atezolizumab and placebo IV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention. | Up to 16.4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Oncologico Korben | Ciudad Autonoma Buenos Aires | C1426AGE | Argentina | |||
| Sunshine Coast University Hospital |
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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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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Participants were randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
A total of 56 participants with programmed death-ligand 1 (PD-L1)-positive Stage IIB, IIIA, or select IIIB (T3N2 only) non-small cell lung cancer (NSCLC) following resection and adjuvant platinum-based chemotherapy took part in the study at 35 investigative sites in 10 countries from 21 March 2024 to 16 December 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab + Placebo | Participants received atezolizumab, 1680 milligrams (mg), in combination with or without placebo as intravenous (IV) co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity. |
| FG001 | Tiragolumab + Atezolizumab |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2024 |
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| Tiragolumab | Drug | Tiragolumab will be administered IV. |
|
|
| Placebo | Drug | Placebo will be administered IV. |
|
| Birtinya |
| Queensland |
| 4575 |
| Australia |
| Monash Health | Clayton | Victoria | 3168 | Australia |
| Crio - Centro Regional Integrado de Oncologia | Fortaleza | Ceará | 60336-232 | Brazil |
| Nucleo de Oncologia da Bahia - NOB | Salvador, Bahia | Estado de Bahia | 40170-380 | Brazil |
| Hospital de ClÃnicas de Passo Fundo | Passo Fundo | Rio Grande do Sul | 99010-260 | Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre | Rio Grande do Sul | 91350-200 | Brazil |
| Hospital de Cancer de Barretos | Barretos | São Paulo | 14784-400 | Brazil |
| Changzhou First People's Hospital | Changzhou | 213003 | China |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | 510080 | China |
| Shandong Cancer Hospital | Jinan | 250117 | China |
| Yunnan Cancer Hospital | Kunming | 650118 | China |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | Nanjing | 210008 | China |
| Ningbo No.2 Hospital | Ningbo | DUMMY_VALUE | China |
| Liaoning Provincial Cancer Hospital | Shengyang | 110042 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | 430030 | China |
| Zhejiang Cancer Hospital | Zhejiang | 310022 | China |
| Ospedale P. Pederzoli Casa di cura Privata | Peschiera Del Garda (VR) | Veneto | 37019 | Italy |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Kindai University Hospital | Osaka | 589-8511 | Japan |
| Instytut Gruzlicy I Chorob Pluc | Warsaw | 01-138 | Poland |
| Pusan National University Hospital | Busan | 602-739 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Pusan National University Yangsan Hospital | Gyeongsangnam-do | 50612 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 463-707 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | 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 |
| E-DA Hospital | Kaohsiung City | 824 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407 | Taiwan |
| National Taiwan University Cancer Center | Zhongzheng Dist. | 106 | Taiwan |
| Vajira Hospital | Bangkok | 10300 | Thailand |
| Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji | Bakirkoy / Istanbul | 34147 | Turkey (Türkiye) |
Participants received a fixed dose of tiragolumab, 840 mg, in combination with atezolizumab, 1680 mg as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity. |
| Safety Analysis Set (SAS) | SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. |
|
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all randomized participants, with participants analyzed according to the treatment assigned.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab + Placebo | Participants received atezolizumab, 1680 mg, in combination with or without placebo as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity. |
| BG001 | Tiragolumab + Atezolizumab | Participants received a fixed dose of tiragolumab, 840 mg, in combination with atezolizumab, 1680 mg as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention. | SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis. | Posted | Count of Participants | Participants | Up to 16.4 months |
|
|
|
Up to 16.4 months
SAS included all participants exposed to the study treatment, with participants analyzed according to the treatment actually received. Two participants randomized to the Tiragolumab + Atezolizumab arm did not receive tiragolumab and were treated with atezolizumab only, therefore, they were included in the Atezolizumab ± Placebo arm for safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atezolizumab ± Placebo | Participants received atezolizumab, 1680 mg, in combination with or without placebo as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity. | 2 | 28 | 5 | 28 | 23 | 28 |
| EG001 | Tiragolumab + Atezolizumab | Participants received a fixed dose of tiragolumab, 840 mg, in combination with atezolizumab, 1680 mg as IV co-infusion on Day 1 of each 28-day cycle for up to 13 cycles in the absence of disease recurrence, or unacceptable toxicity. | 0 | 24 | 9 | 24 | 21 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinus node dysfunction | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Post procedural inflammation | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Encephalitis autoimmune | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 28.1 | 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 | Hoffmann-La Roche | genentech@druginfo.com |
| May 14, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000730814 | Tiragolumab |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|