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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002851-39 | EudraCT Number | ||
| 2022-502031-20-00 | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tiragolumab in combination with atezolizumab plus pemetrexed and carboplatin/cisplatin (Arm A) compared with placebo in combination with pembrolizumab plus pemetrexed and carboplatin/cisplatin (Arm B) in participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC).
Eligible participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during the induction phase:
Following the induction phase, participants will continue maintenance therapy with either tiragolumab in combination with atezolizumab and pemetrexed (Arm A) or placebo in combination with pembrolizumab and pemetrexed (Arm B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiragolumab+Atezolizumab+Pemetrexed+Carboplatin or Cisplatin | Experimental | Induction treatment with tiragolumab in combination with atezolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with tiragolumab in combination with atezolizumab and pemetrexed on Day 1 of each 21-day cycle. |
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| Placebo+Pembrolizumab+Pemetrexed+Carboplatin or Cisplatin | Placebo Comparator | Induction treatment with placebo in combination with pembrolizumab plus pemetrexed and cisplatin or carboplatin will be administered to participants on Day 1 of each 21-day cycle for 4 cycles. Following the induction phase, participants will continue maintenance therapy with placebo in combination with pembrolizumab and pemetrexed on Day 1 of each 21-day cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiragolumab | Drug | Tiragolumab at a fixed dose of 600 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 |
|---|---|---|
| Progression-free Survival (PFS) as Determined by the Investigator | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. Kaplan-Meier (KM) methodology was used to estimate the median PFS. | From randomization to first occurrence of PD or death from any cause (up to approximately 40 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. | From randomization to death from any cause (up to approximately 40 months) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS as Determined by the Independent Review Facility (IRF) | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS. |
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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 |
|---|---|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | United States | ||
| PIH Health Whittier Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42060297 | Derived | Socinski MA, Stahel R, Lee DH, Cappuzzo F, Nishio M, Lovly CM, Ozyilkan O, Li Q, Johnson M, Garon EB, Kilickap S, Ferreira da Silva FA, Alatorre-Alexander J, Meng R, Amin R, Matheny C, Troutman S, Wen X, Patil NS, Zou W, Rodriguez-Abreu D. Tiragolumab Plus Atezolizumab and Chemotherapy for Advanced Nonsquamous Non-Small Cell Lung Cancer: The Phase 3 SKYSCRAPER-06 Randomized Clinical Trial. JAMA Oncol. 2026 Jun 1;12(6):619-627. doi: 10.1001/jamaoncol.2026.0818. |
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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 + atezolizumab + chemotherapy or placebo + pembrolizumab + chemotherapy. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
A total of 542 participants with previously untreated, locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) took part in the study at 129 investigative sites across 21 countries from 15 December 2020 to 20 November 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + Pembrolizumab + Chemotherapy | Participants received pembrolizumab at a fixed dose 200 milligrams (mg), placebo, pemetrexed, 500 milligram per square meter (mg/m^2), and either carboplatin, area under the curve (AUC) of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with pembrolizumab, placebo and pemetrexed at the same dose as induction treatment, as IV infusion, on Day 1 of each 21-day cycle from Cycle 5 onwards, until disease progression (PD), 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 | Jul 15, 2024 | May 7, 2026 |
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| Atezolizumab | Drug | Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle. |
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| Pemetrexed | Drug | Pemetrexed 500 milligrams per square meter (mg/m^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle. |
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| Carboplatin | Drug | Carboplatin at dose of area under the concentration-time curve (AUC) of 5, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles. |
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| Cisplatin | Drug | Cisplatin 75 mg/m^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles. |
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| Tiragolumab Matching Placebo | Drug | Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle. |
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| Pembrolizumab | Drug | Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle. |
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| From randomization to first occurrence of PD or death from any cause (up to approximately 40 months) |
| Investigator Assessed PFS in Participants With PD-L1 Expression at TPS/TC >=1% | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS. | From randomization to first occurrence of PD or death from any cause (up to approximately 40 months) |
| Investigator Assessed PFS in Participants With PD-L1 Expression at TPS/TC >=50% | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS. | From randomization to first occurrence of PD or death from any cause (up to approximately 40 months) |
| OS in Participants With PD-L1 Expression at TPS/TC >=1% | OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS. | From randomization to death from any cause (up to approximately 40 months) |
| OS in Participants With PD-L1 Expression at TPS/TC >= 50% | OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS. | From randomization to death from any cause (up to approximately 40 months) |
| PFS Rate at Month 6 and Month 12 | PFS at 6 months and 12 months was defined as the percentage of participants who have not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 months and at 12 months, respectively. 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. | At Month 6 and Month 12 |
| OS Rate at Month 12 and Month 24 | OS rate at 12 months and 24 months was defined as the percentage of participants who have not experienced death from any cause at 12 and 24 months, respectively. | At Month 12 and Month 24 |
| Duration of Response (DOR) | DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. Complete response (CR) was defined as the disappearance of all target and non-target lesions. 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 SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Partial response (PR) 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. | Up to approximately 40 months |
| Objective Response Rate (ORR) | ORR was defined as a percentage of participants with a CR or 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. 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. Percentages have been rounded off. | Up to approximately 40 months |
| Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning (PF) as Measured by European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC-QLQ-C30) | EORTC QLQ-C30=self-reported measure, with 30 questions assessing 5 aspects of subjects functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, & pain), global health status (GHS) & Quality of Life (QoL), & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) within the previous week. Functioning & symptoms items were scored on a 4-point scale: 1=not at all to 4=very much. Scores were linearly transformed to a range of 0 to 100, with higher scores reflecting better functioning. TTCD was defined time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration was defined as score decrease of ≥10 from baseline in PF scale score that were held for at least two consecutive assessments or an initial ≥10 decrease from baseline followed by death from any cause within 3 weeks. | Up to approximately 40 months |
| TTCD in Participant-Reported Global Health Status (GHS)/Quality of Life (QoL) as Measured by EORTC QLQ-C30 | EORTC QLQ-C30=self-reported measure, with 30 questions assessing 5 aspects of subjects functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, & pain), global health status (GHS) & Quality of Life (QoL), & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) within the previous week . GHS and QoL items were scored on a 7-point scale (1=very poor 7=excellent). Scores were linearly transformed to a range of 0 to 100, with higher scores reflecting better GHS/QoL. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration was defined as score decrease of ≥10 from baseline in GHS/QoL scale score that were held for at least two consecutive assessments or an initial ≥10 decrease from baseline followed by death from any cause within 3 weeks. | Up to approximately 40 months |
| TTCD in Participant-Reported Dyspnoea as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Symptoms were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of dyspnoea. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks. | Up to approximately 40 months |
| TTCD in Participant-Reported Chest Pain, as Measured by EORTC QLQ-LC13 | The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Chest pain were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of chest pain. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks. | Up to approximately 40 months |
| TTCD in Participant-Reported Cough, as Measured by EORTC QLQ-LC13 | The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Cough were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of cough. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks. | Up to approximately 40 months |
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. | From study start up to 90 days after last dose (up to approximately 40.8 months) |
| Number of Participants With Response to Side Effects of Treatment as Assessed by European Organisation for Research and Treatment of Cancer Item List 46 (EORTC IL46) | The EORTC IL46 is a validated single-item question that assesses overall side effect impact, i.e. "To what extent have you been troubled with side-effects from your treatment ". Each item is scored on a 4-point scale (1= Not at all, 2= A Little, 3= Quite a Bit, and 4= Very Much). | Baseline, Day 1 of Cycles 2, 3, 4, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57 and treatment discontinuation visit (each cycle=21 days) (Up to 40 months) |
| Serum Concentration of Atezolizumab | Predose Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 and at treatment completion (TC)/early discontinuation (ED); and 0.5 hour (h) postdose Day 1 of Cycle 1 (each cycle=21 days) (Up to 40 months) |
| Serum Concentration of Tiragolumab | Predose Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 and at TC/ED; and 0.5 hour (h) postdose Day 1 of Cycle 1 (each cycle=21 days) (Up to 40 months) |
| Number of Participants With Treatment-Emergent Anti-drug Antibodies (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 40 months |
| Number of Participants With Treatment-Emergent 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 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 40 months |
| Whittier |
| California |
| 90602 |
| United States |
| SCRI Florida Cancer Specialists South | Fort Myers | Florida | 33901 | United States |
| SCRI Florida Cancer Specialists North | St. Petersburg | Florida | 33705 | United States |
| Advent Health Orlando | Winter Park | Florida | 32789 | United States |
| Northwest Georgia Oncology Centers PC - Marietta | Marietta | Georgia | 30060 | United States |
| Fort Wayne Medical Oncology and Hematology, Inc | Fort Wayne | Indiana | 46804 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Tennessee Oncology Chattanooga | Chattanooga | Tennessee | 37403 | United States |
| Sarah Cannon Research Institute / Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Inova Schar Cancer Institute | Fairfax | Virginia | 22031 | United States |
| AZORG Campus Aalst-Moorselbaan | Aalst | 9300 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| CHU UCL Mont-Godinne | Mont-godinne | 5530 | Belgium |
| Vitaz | Sint-Niklaas | 9100 | Belgium |
| Crio - Centro Regional Integrado de Oncologia | Fortaleza | Ceará | 60336-550 | Brazil |
| Oncocentro Belo Horizonte | Belo Horizonte | Minas Gerais | 30360-680 | Brazil |
| Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital das Clinicas - UFRGS | Porto Alegre | Rio Grande do Sul | 90035-903 | 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 |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada |
| Royal Victoria Regional Health Centre | Barrie | Ontario | L4M 6M2 | Canada |
| Lakeridge Health Oshawa | Oshawa | Ontario | L1G 2B9 | Canada |
| Sault Area Hospital | Sault Ste. Marie | Ontario | P6B 0A8 | Canada |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| Jilin Cancer Hospital | Changchun | 132013 | China |
| Xiangya Hospital Central South University | Changsha | 410008 | China |
| Affiliated Hospital of Chengde Medical University | Chengde | 067020 | China |
| Sichuan Cancer Hospital | Chengdu | 610041 | China |
| West China Hospital - Sichuan University | Chengdu | 610047 | China |
| Anhui Provincial Hospital | Hefei | 230088 | China |
| Jinan Central Hospital | Jinan | 250013 | China |
| Pingxiang People's Hospital | Pingxiang | 337000 | China |
| Qingdao Central Hospital | Qingdao | 266042 | China |
| Weifang People's Hospital | Weifang | 261041 | China |
| Hubei Cancer Hospital | Wuhan | 430079 | China |
| The First Affiliated Hospital of Xian Jiao Tong University | Xi'an | 710061 | China |
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | 453000 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | 450052 | China |
| Rigshospitalet | København Ø | 2100 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling R | Odense C | 5000 | Denmark |
| Sjællands Universitetshospital, Roskilde | Roskilde | 4000 | Denmark |
| Institut Bergonie | Bordeaux | 33076 | France |
| Hopital Nord | Marseille | 13915 | France |
| Hopital de Pontchaillou | Rennes | 35033 | France |
| CHU Strasbourg - Nouvel Hopital Civil | Strasbourg | 67091 | France |
| CHU de Toulouse - Hôpital Larrey | Toulouse | 31100 | France |
| Helios Klinikum Emil von Behring GmbH | Berlin | 14165 | Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | 09116 | Germany |
| St. Vincentius Kliniken Karlsruhe | Karlsruhe | 76137 | Germany |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie | Mainz | 55131 | Germany |
| Klinikum der Philipps-Universität Marburg | Marburg | 35032 | Germany |
| Hong Kong United Oncology Centre | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Tuen Mun Hospital | Hong Kong | Hong Kong |
| Prince of Wales Hospital | Shatin | Hong Kong |
| Centro Di Riferimento Oncologico | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| A.O. Villa Scassi | Genoa | Liguria | 16149 | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Tuscany | 50139 | Italy |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| Kurume University Hospital | Fukuoka | 830-0011 | Japan |
| Hiroshima University Hospital | Hiroshima | 734-8551 | Japan |
| Takarazuka City Hospital | Hyōgo | 665-0827 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Sendai Kousei Hospital | Miyagi | 981-0914 | Japan |
| Osaka International Cancer Institute | Osaka | 541-8567 | Japan |
| Kansai Medical University Hospital | Osaka | 573-1191 | Japan |
| Kindai University Hospital | Osaka | 589-8511 | Japan |
| NHO Kinki Chuo Chest Medical Center | Osaka | 591-8555 | Japan |
| Saitama Cancer Center | Saitama | 362-0806 | Japan |
| The Cancer Institute Hospital of JFCR | Tokyo | 135-8550 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641-8510 | Japan |
| Cuidados oncologicos | Querétaro City | Querétaro | 76000 | Mexico |
| Oncologico Potosino | San Luis Potosí City | San Luis Potosí | 78209 | Mexico |
| ARKE Estudios Clínicos S.A. de C.V. | Mexico City | 06700 | Mexico |
| Auckland City Hospital, Cancer and Blood Research | Auckland | 1023 | New Zealand |
| Waikato Hospital - Cancer and Blood Research Trials Unit | Hamilton | 3204 | New Zealand |
| Palmerston North Hospital | Palmerston North | 4442 | New Zealand |
| Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna | Lódz | 90-338 | Poland |
| Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie | Olsztyn | 10-357 | Poland |
| Kosin University Gospel Hospital | Busan | 49267 | South Korea |
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| St. Vincent's Hospital | Gyeonggi-do | 16247 | South Korea |
| Samsung Changwon Hospital | Gyeongsangnam-do | 51353 | 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 |
| Seoul St Mary's Hospital | Seoul | 06591 | South Korea |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| ICO L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Complejo Hospitalario Universitario Insular?Materno Infantil | Las Palmas de Gran Canaria | LAS Palmas | 35016 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | 15006 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| Hospital Lucus Augusti | Lugo | 27003 | Spain |
| Hospital General Universitario Gregorio Marañon | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Univ. Nuestra Señora de Valme | Seville | 41014 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Kantonsspital Aarau | Aarau | 5001 | Switzerland |
| Kantonsspital Graubünden Medizin Onkologie | Chur | 7000 | Switzerland |
| UniversitätsSpital Zürich | Zurich | 8091 | Switzerland |
| Changhua Christian Hospital | Chang-hua | 500 | Taiwan |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Vajira Hospital | Bangkok | 10300 | Thailand |
| Chulalongkorn Hospital | Bangkok | 10330 | Thailand |
| Faculty of Med. Siriraj Hosp. | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | 50200 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Adana Baskent University Medical Faculty | Adana | 01220 | Turkey (Türkiye) |
| Ankara Bilkent City Hospital | Ankara | 06490 | Turkey (Türkiye) |
| Liv Hospital Ankara | Ankara | 06680 | Turkey (Türkiye) |
| Dicle University Faculty of Medicine | Diyarbakır | 21280 | Turkey (Türkiye) |
| Trakya University Medical Faculty | Edirne | 22030 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34000 | Turkey (Türkiye) |
| Medeniyet University Goztepe Training and Research Hospital. | Kadiköy | 34722 | Turkey (Türkiye) |
| Castle Hill Hospital | Hull | HU16 5JQ | United Kingdom |
| Barts & London School of Med | London | EC1A 7BE | United Kingdom |
| Guy'S Hospital | London | SE1 9RT | United Kingdom |
| Christie Hospital Nhs Trust | Manchester | M2O 4BX | United Kingdom |
| Nottingham City Hospital | Nottingham | NG5 1PB | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| FG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
| Safety-evaluable Set | Safety-evaluable set included all participants randomized to the study and who received at least one dose of study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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Full Analysis Set (FAS) included all randomized participants whether or not the participants received the assigned treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + Pembrolizumab + Chemotherapy | Participants received pembrolizumab at a fixed dose 200 mg, placebo, pemetrexed, 500 mg/m^2, and either carboplatin, AUC of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with pembrolizumab, placebo and pemetrexed at the same dose as induction treatment, as IV infusion, on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
| BG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
| 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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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Progression-free Survival (PFS) as Determined by the Investigator | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) criteria, or death from any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. Kaplan-Meier (KM) methodology was used to estimate the median PFS. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to first occurrence of PD or death from any cause (up to approximately 40 months) |
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| Primary | 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. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to death from any cause (up to approximately 40 months) |
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| Secondary | PFS as Determined by the Independent Review Facility (IRF) | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS. | Per protocol, centralized, blinded review of responses and endpoints by IRF may be conducted at the sponsor's discretion. Since protocol was amended to stop the submission of primary imaging data used for tumor assessments to IRF, no data was collected for this endpoint. | Posted | From randomization to first occurrence of PD or death from any cause (up to approximately 40 months) |
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| Secondary | Investigator Assessed PFS in Participants With PD-L1 Expression at TPS/TC >=1% | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1 criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS. | PD-L1 TPS/TC >=1% subgroup population included all FAS participants with PD-L1 expression at TPS/TC >=1% , as determined by central testing with investigational Ventana PD-L1 (SP263) assay. FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to first occurrence of PD or death from any cause (up to approximately 40 months) |
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| Secondary | Investigator Assessed PFS in Participants With PD-L1 Expression at TPS/TC >=50% | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria, 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. KM methodology was used to estimate the median PFS. | PD-L1 TPS/TC >=50% subgroup population included all FAS participants with PD-L1 expression at TPS/TC>=50%, as determined by central testing with investigational Ventana PD-L1 (SP263) assay. FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to first occurrence of PD or death from any cause (up to approximately 40 months) |
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| Secondary | OS in Participants With PD-L1 Expression at TPS/TC >=1% | OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS. | PD-L1 TPS/TC >=1% subgroup population included all FAS participants with PD-L1 expression at TPS/TC >=1%, as determined by central testing with investigational Ventana PD-L1 (SP263) assay. FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to death from any cause (up to approximately 40 months) |
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| Secondary | OS in Participants With PD-L1 Expression at TPS/TC >= 50% | OS was defined as the time from randomization to death from any cause. KM methodology was used to estimate the median OS. | PD-L1 TPS/TC >=50% subgroup population included all FAS participants with PD-L1 expression at TPS/TC>=50%, as determined by central testing with investigational Ventana PD-L1 (SP263) assay. FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | From randomization to death from any cause (up to approximately 40 months) |
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| Secondary | PFS Rate at Month 6 and Month 12 | PFS at 6 months and 12 months was defined as the percentage of participants who have not experienced PD as determined by the investigator according to RECIST v1.1 or death from any cause at 6 months and at 12 months, respectively. 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), in addition to the relative increase of 20%, the SOD must also demonstrate an absolute increase of ≥5 mm or unequivocal progression of existing non-target lesions. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Month 6 and Month 12 |
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| Secondary | OS Rate at Month 12 and Month 24 | OS rate at 12 months and 24 months was defined as the percentage of participants who have not experienced death from any cause at 12 and 24 months, respectively. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Month 12 and Month 24 |
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| Secondary | Duration of Response (DOR) | DOR was defined as the time from the first occurrence of a documented objective response (OR) to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. Complete response (CR) was defined as the disappearance of all target and non-target lesions. 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 SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. Partial response (PR) 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. | FAS included all randomized participants whether or not the participants received the assigned treatment. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | months | Up to approximately 40 months |
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| Secondary | Objective Response Rate (ORR) | ORR was defined as a percentage of participants with a CR or 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. 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. Percentages have been rounded off. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 40 months |
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| Secondary | Time to Confirmed Deterioration (TTCD) in Participant-Reported Physical Functioning (PF) as Measured by European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC-QLQ-C30) | EORTC QLQ-C30=self-reported measure, with 30 questions assessing 5 aspects of subjects functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, & pain), global health status (GHS) & Quality of Life (QoL), & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) within the previous week. Functioning & symptoms items were scored on a 4-point scale: 1=not at all to 4=very much. Scores were linearly transformed to a range of 0 to 100, with higher scores reflecting better functioning. TTCD was defined time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration was defined as score decrease of ≥10 from baseline in PF scale score that were held for at least two consecutive assessments or an initial ≥10 decrease from baseline followed by death from any cause within 3 weeks. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 40 months |
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| Secondary | TTCD in Participant-Reported Global Health Status (GHS)/Quality of Life (QoL) as Measured by EORTC QLQ-C30 | EORTC QLQ-C30=self-reported measure, with 30 questions assessing 5 aspects of subjects functioning (physical, emotional, role, cognitive & social), 3 symptom scales (fatigue, nausea & vomiting, & pain), global health status (GHS) & Quality of Life (QoL), & 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea & financial difficulties) within the previous week . GHS and QoL items were scored on a 7-point scale (1=very poor 7=excellent). Scores were linearly transformed to a range of 0 to 100, with higher scores reflecting better GHS/QoL. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration was defined as score decrease of ≥10 from baseline in GHS/QoL scale score that were held for at least two consecutive assessments or an initial ≥10 decrease from baseline followed by death from any cause within 3 weeks. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 40 months |
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| Secondary | TTCD in Participant-Reported Dyspnoea as Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) | The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Symptoms were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of dyspnoea. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 40 months |
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| Secondary | TTCD in Participant-Reported Chest Pain, as Measured by EORTC QLQ-LC13 | The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Chest pain were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of chest pain. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 40 months |
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| Secondary | TTCD in Participant-Reported Cough, as Measured by EORTC QLQ-LC13 | The EORTC QLQ-LC13 is comprised of 13 lung cancer-specific items and includes 11 disease-specific scales/items (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, pain medication). Cough were scored on a 4-point scale: 1=not at all to 4=very much. Scores are linearly transformed to a range of 0 to 100. A higher score indicates a worse level of cough. TTCD was defined as time from the date of randomization until the first confirmed clinically meaningful deterioration. Confirmed clinically meaningful deterioration in symptoms was defined as a score increase of ≥ 10-point from baseline in a symptom score that must be held for at least two consecutive assessments or an initial increase ≥ 10-point from baseline followed by death from any cause within 3 weeks. | FAS included all randomized participants whether or not the participants received the assigned treatment. | Posted | Median | 95% Confidence Interval | months | Up to approximately 40 months |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptoms, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. | Safety-evaluable set included all participants randomized to the study and who received at least one dose of study treatment. | Posted | Count of Participants | Participants | From study start up to 90 days after last dose (up to approximately 40.8 months) |
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| Secondary | Number of Participants With Response to Side Effects of Treatment as Assessed by European Organisation for Research and Treatment of Cancer Item List 46 (EORTC IL46) | The EORTC IL46 is a validated single-item question that assesses overall side effect impact, i.e. "To what extent have you been troubled with side-effects from your treatment ". Each item is scored on a 4-point scale (1= Not at all, 2= A Little, 3= Quite a Bit, and 4= Very Much). | Safety-evaluable set included all participants randomized to the study and who received at least one dose of study treatment. | Posted | Count of Participants | Participants | Baseline, Day 1 of Cycles 2, 3, 4, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47, 49, 51, 53, 55, 57 and treatment discontinuation visit (each cycle=21 days) (Up to 40 months) |
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| Secondary | Serum Concentration of Atezolizumab | Atezolizumab PK evaluable population included all randomized participants who received any dose of atezolizumab and who have at least one post-baseline pharmacokinetic (PK) sample available. 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 Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 and at treatment completion (TC)/early discontinuation (ED); and 0.5 hour (h) postdose Day 1 of Cycle 1 (each cycle=21 days) (Up to 40 months) |
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| Secondary | Serum Concentration of Tiragolumab | Tiragolumab PK evaluable population included all randomized participants who received any dose of tiragolumab and who have at least one post-baseline PK sample available. 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 Day 1 of Cycles 1, 2, 3, 4, 8, 12, 16 and at TC/ED; and 0.5 hour (h) postdose Day 1 of Cycle 1 (each cycle=21 days) (Up to 40 months) |
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| Secondary | Number of Participants With Treatment-Emergent Anti-drug Antibodies (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. | Safety-evaluable set included all participants randomized to the study and who received at least one dose of study treatment. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to approximately 40 months |
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| Secondary | Number of Participants With Treatment-Emergent 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 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. | Safety-evaluable set included all participants randomized to the study and who received at least one dose of study treatment. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to approximately 40 months |
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All AEs: From study start up to 90 days after last dose (up to approximately 40.8 months)
All cause mortality: FAS included all randomized participants whether or not the participants received the assigned treatment.
AE: Safety-evaluable set included all participants randomized to the study and who received at least one dose of study treatment.
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 + Pembrolizumab + Chemotherapy | Participants received pembrolizumab at a fixed dose 200 mg, placebo, pemetrexed, 500 mg/m^2, and either carboplatin, AUC of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with pembrolizumab, placebo and pemetrexed at the same dose as induction treatment, as IV infusion, on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. | 117 | 273 | 142 | 272 | 262 | 272 |
| EG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. | 146 | 269 | 147 | 267 | 251 | 267 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
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| Haematotoxicity | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
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| Myelosuppression | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Cardiac tamponade | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Cardiac ventricular thrombosis | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Myocarditis | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA version 28.1 | Systematic Assessment |
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| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA version 28.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA version 28.1 | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA version 28.1 | Systematic Assessment |
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| Addison's disease | Endocrine disorders | MedDRA version 28.1 | Systematic Assessment |
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| Adrenal insufficiency | Endocrine disorders | MedDRA version 28.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA version 28.1 | Systematic Assessment |
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| Retinal artery occlusion | Eye disorders | MedDRA version 28.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Aorto-oesophageal fistula | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Diverticulum intestinal | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Immune-mediated gastritis | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Neutropenic colitis | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Obturator hernia | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Pneumoperitoneum | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA version 28.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA version 28.1 | Systematic Assessment |
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| Death | General disorders | MedDRA version 28.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version 28.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA version 28.1 | Systematic Assessment |
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| Hyperthermia | General disorders | MedDRA version 28.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA version 28.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | 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 |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Metabolic dysfunction-associated steatohepatitis | Hepatobiliary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Immunosuppression | Immune system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | 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 |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Hepatitis E | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pseudomonas infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Humerus fracture | 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 |
| |
| Radiation necrosis | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Tracheostomy malfunction | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA version 28.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Amoeba test positive | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Aspartate aminotransferase 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 |
| |
| Blood magnesium decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Creatinine renal clearance decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Fulminant type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypophagia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Refeeding syndrome | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Autoimmune myositis | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Muscular weakness | 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 |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.1 | Systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.1 | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.1 | Systematic Assessment |
| |
| Transitional cell carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.1 | Systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Immune-mediated encephalitis | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Renal tubular dysfunction | Renal and urinary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal 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 |
| |
| Hypoxia | 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 |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonitis | 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 |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Respiratory tract oedema | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Cellulite | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Spinal operation | Surgical and medical procedures | MedDRA version 28.1 | Systematic Assessment |
| |
| Aortic intramural haematoma | Vascular disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Distributive shock | Vascular disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypertension | 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 |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Thrombocytopenia | 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 |
| |
| Lacrimation increased | Eye 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 |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Stomatitis | 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 |
| |
| Chest pain | General disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Mucosal inflammation | 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 |
| |
| COVID-19 | Infections and infestations | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonia | 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 |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 28.1 | Systematic Assessment |
| |
| White blood cell count decreased | 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 |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Hyponatraemia | 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 |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Dysgeusia | 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 |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 28.1 | Systematic Assessment |
| |
| Dry skin | 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 | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2022 | May 7, 2026 | 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 |
|---|---|
| C000730814 | Tiragolumab |
| C000594389 | atezolizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| C582435 | pembrolizumab |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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 |
|
| two-sided, inverse normal combination |
| 0.0176 |
Stratification factors are PD-L1 Status (TPS/TC <1% vs 1-49% vs >= 50%), Geographic Region (Asia vs Non-Asia) and ECOG Performance Status (0 vs 1). |
| Superiority |
|
|
|
Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
|
| OG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
|
|
|
| OG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
|
|
|
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|
| OG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
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|
|
| OG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
|
|
|
| OG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
|
|
|
| OG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
|
|
|
| OG001 | Tiragolumab + Atezolizumab + Chemotherapy | Participants received atezolizumab at a fixed dose of 1200 mg, tiragolumab at a fixed dose of 600 mg, pemetrexed, 500 mg/m^2, and either carboplatin, AUC 5 of 5 or cisplatin 75 mg/m^2 as IV infusion on Day 1 of each 21-day cycle as induction treatment (Cycles 1-4). Participants then received maintenance treatment with atezolizumab, tiragolumab and pemetrexed at the same dose as induction treatment as IV infusion on Day 1 of each 21-day cycle from Cycle 5 onwards, until PD, loss of clinical benefit or unacceptable toxicity. |
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