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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000280-81 | EudraCT Number | ||
| 2023-508083-30-00 | EU Trial (CTIS) Number |
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This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + Atezolizumab | Placebo Comparator | Participants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
|
| Tiragolumab + Atezolizumab | Experimental | Participants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months) |
| Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. Kaplan-Meier (KM) methodology was used to estimate the median PFS. | From baseline until a total of 80 PFS events have occurred (up to approximately 11 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Objective Response (DOR) | DOR was defined as the time from the first occurrence of a documented objective response (OR) (CR or PR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. KM methodology was used to estimate the median DOR. |
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Inclusion Criteria:
Exclusion Criteria:
Cancer-Specific Exclusions:
General Medical Exclusions:
Treatment-Specific Exclusions:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Oncology Associates, PC - HAL | Tempe | Arizona | 85284 | United States | ||
| SCRI Florida Cancer Specialists South |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38418879 | Derived | Guan X, Hu R, Choi Y, Srivats S, Nabet BY, Silva J, McGinnis L, Hendricks R, Nutsch K, Banta KL, Duong E, Dunkle A, Chang PS, Han CJ, Mittman S, Molden N, Daggumati P, Connolly W, Johnson M, Abreu DR, Cho BC, Italiano A, Gil-Bazo I, Felip E, Mellman I, Mariathasan S, Shames DS, Meng R, Chiang EY, Johnston RJ, Patil NS. Anti-TIGIT antibody improves PD-L1 blockade through myeloid and Treg cells. Nature. 2024 Mar;627(8004):646-655. doi: 10.1038/s41586-024-07121-9. Epub 2024 Feb 28. | |
| 35576957 |
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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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Participants were randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
A total of 135 participants with previously untreated, locally advanced, unresectable, or metastatic programmed death-ligand 1 (PD-L1)-selected non-small cell lung cancer (NSCLC) took part in the study at 39 investigative sites across 6 countries from 08 Aug 2018 to 14 Nov 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Atezolizumab | Participants received atezolizumab at a fixed dose of 1200 milligrams (mg), and placebo as intravenous (IV) infusions, every 3 weeks (Q3W) on Day 1 of each 21-day cycle until disease progression (PD), loss of clinical benefit or unacceptable toxicity as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria. |
| 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 25, 2023 |
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|
| Tiragolumab | Drug | Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
|
|
| Placebo | Drug | Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
|
| Up to approximately 36 months |
| Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS. | Up to approximately 36 months |
| Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | From initiation of study drug up to approximately 83.7 months |
| Minimum Serum Concentration (Cmin) of Tiragolumab | Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days) |
| Cmin of Atezolizumab | Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days) |
| Number of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Tiragolumab | Participants who received tiragolumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. | Up to approximately 36 months |
| Number of Participants With Treatment-Emergent ADAs to Atezolizumab | Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. | Up to approximately 36 months |
| Fort Myers |
| Florida |
| 33901 |
| United States |
| Florida Cancer Specialists - NORTH - SCRI - PPDS | St. Petersburg | Florida | 33705 | United States |
| Illinois Cancer Specialists | Arlington Heights | Illinois | 60005 | United States |
| Illinois Cancer Care | Peoria | Illinois | 61615 | United States |
| University of Kansas Medical Center | Westwood | Kansas | 66205 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| SCRI Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | United States |
| Northwest Cancer Specialists - Vancouver | Vancouver | Washington | 98684 | United States |
| ICO Paul Papin | Angers | 49055 | France |
| Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest | Bordeaux | 33076 | France |
| Centre Georges François Leclerc | Dijon | 21079 | France |
| Hopital Nord AP-HM | Marseille | 13015 | France |
| Institut De Cancerologie De L'Ouest | Saint-Herblain | 44115 | France |
| Institute of Lung Diseases Vojvodina | Kamenitz | Južnobanatski Okrug | 21204 | Serbia |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Clinical Hospital Center Bezanijska Kosa | Belgrade | 11070 | Serbia |
| Chungbuk National University Hospital | Cheongju-si | 28644 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hospital Univ Germans Trias i Pujol | Badalona | Barcelona | 8916 | Spain |
| Complejo Hospitalario Universitario Insular?Materno Infantil | Las Palmas de Gran Canaria | LAS Palmas | 35016 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Universitario Vall d'Hebron - PPDS | Barcelona | 08035 | Spain |
| Clinica Universitaria Navarra (Madrid) | Madrid | 28036 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Madrid | 28222 | Spain |
| Hospital Regional Universitario de Malaga ? Hospital General | Málaga | 29010 | Spain |
| Centro Medico Quironsalud Sagrado Corazon | Seville | 41013 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Taipei Medical University ?Shuang Ho Hospital | New Taipei City | 23561 | Taiwan |
| National Cheng Kung University Hospital | North Dist. | 70403 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 1121 | Taiwan |
| Chang Gung Memorial Hospital - Linkou | Taoyuan | 333 | Taiwan |
| Derived |
| Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792. doi: 10.1016/S1470-2045(22)00226-1. Epub 2022 May 13. |
| FG001 | Tiragolumab + Atezolizumab | Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) population included all participants randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Atezolizumab | Participants received atezolizumab at a fixed dose of 1200 mg, and placebo as IV infusions, Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria. |
| BG001 | Tiragolumab + Atezolizumab | Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria. |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | ORR was defined as a complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Percentages have been rounded off. | ITT population included all participants randomized in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | From baseline until a total of 80 progression-free survival (PFS) events have occurred (up to approximately 11 months) |
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| Primary | Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. Kaplan-Meier (KM) methodology was used to estimate the median PFS. | ITT population included all participants randomized in the study. | Posted | Median | 95% Confidence Interval | months | From baseline until a total of 80 PFS events have occurred (up to approximately 11 months) |
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| Secondary | Duration of Objective Response (DOR) | DOR was defined as the time from the first occurrence of a documented objective response (OR) (CR or PR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. In addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm. KM methodology was used to estimate the median DOR. | ITT population included all participants randomized in the study. Overall number analyzed is the number of participants who achieved the best confirmed OR (CR or PR). | Posted | Median | 95% Confidence Interval | months | Up to approximately 36 months |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS. | ITT population included all participants randomized in the study. | Posted | Median | 95% Confidence Interval | months | Up to approximately 36 months |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Safety-evaluable population included all randomized participants who received at least one dose of tiragolumab, placebo or atezolizumab. | Posted | Count of Participants | Participants | From initiation of study drug up to approximately 83.7 months |
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| Secondary | Minimum Serum Concentration (Cmin) of Tiragolumab | Tiragolumab pharmacokinetic (PK) evaluable population included all randomized participants who received at least one dose of tiragolumab. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (μg/mL) | Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days) |
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| Secondary | Cmin of Atezolizumab | Atezolizumab PK evaluable population included all randomized participants who received at least one dose of atezolizumab. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | Predose on Day 1 of Cycles 1, 3 and 11 (Cycle length = 21 days) |
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| Secondary | Number of Participants With Treatment-Emergent Anti-drug Antibodies (ADAs) to Tiragolumab | Participants who received tiragolumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following tiragolumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. | ADA population included all participants with any ADA assessments, with participants grouped according to treatment received. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to approximately 36 months |
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| Secondary | Number of Participants With Treatment-Emergent ADAs to Atezolizumab | Participants who received atezolizumab were considered to be treatment-emergent ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following atezolizumab exposure (treatment-induced ADA response), or if they were ADA-positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the titer of the baseline sample (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. | ADA population included all participants with any ADA assessments, with participants grouped according to treatment received. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to approximately 36 months |
|
From initiation of study drug up to approximately 83.7 months
Safety-evaluable population included all randomized participants who received at least one dose of tiragolumab, placebo or atezolizumab.
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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 | Placebo + Atezolizumab | Participants received atezolizumab at a fixed dose of 1200 mg, and placebo as IV infusions, Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria. | 57 | 68 | 28 | 68 | 59 | 68 |
| EG001 | Tiragolumab + Atezolizumab | Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria. | 51 | 67 | 40 | 67 | 63 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Adrenal haemorrhage | Endocrine disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Cytomegalovirus colitis | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pleural infection bacterial | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 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 |
| |
| Lipase increased | Investigations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Neurotoxicity | Nervous system disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Vena cava thrombosis | Vascular disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pericardial effusion malignant | Cardiac disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pancreatic cyst | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Dysplasia | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Mucosal ulceration | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Epstein-Barr virus infection reactivation | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA Version 28.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 28.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Immune-mediated nephritis | Renal and urinary disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Embolism | Vascular 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 |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal 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 |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 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 |
| |
| Amylase increased | Investigations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Hypokalaemia | 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 |
| |
| Musculoskeletal chest 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 |
| |
| Headache | Nervous system disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal 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 |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 28.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 28.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue 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 | 800 821-8590 | genentech@druginfo.com |
| Apr 13, 2026 |
| Prot_SAP_001.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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000730814 | Tiragolumab |
Not provided
Not provided
Not provided
| 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 |
|
|
|
|
Participants received atezolizumab at a fixed dose of 1200 mg and tiragolumab at a fixed dose of 600 mg, as IV infusions Q3W on Day 1 of each 21-day cycle until PD, loss of clinical benefit or unacceptable toxicity as determined by the investigator per RECIST v1.1 criteria. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|
|
|
|
|