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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003083-21 | EudraCT Number |
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This randomized, open-label study will evaluate the efficacy and safety of atezolizumab compared with chemotherapy consisting of a platinum agent (cisplatin or carboplatin per investigator discretion) combined with either pemetrexed (non-squamous disease) or gemcitabine (squamous disease) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with Stage IV Non-Squamous or Squamous NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | Active Comparator | Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
| Atezolizumab | Experimental | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody | Drug | Atezolizumab 1200 milligram (mg) will be administered as intravenous infusion every 21 days until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) in the TC3 or IC3-WT Populations | OS is defined as the time from randomization to death from any cause. | From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) |
| Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | OS is defined as the time from randomization to death from any cause. | From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) in the TC3 or IC3-WT Populations | PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested. | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States | ||
| Yale Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39532375 | Derived | Li B, Rong D, Lin H. Atezolizumab monotherapy as first-line treatment for non-small cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a cost-effectiveness analysis in the USA. BMJ Open. 2024 Nov 12;14(11):e083716. doi: 10.1136/bmjopen-2023-083716. | |
| 32997907 | Derived | Herbst RS, Giaccone G, de Marinis F, Reinmuth N, Vergnenegre A, Barrios CH, Morise M, Felip E, Andric Z, Geater S, Ozguroglu M, Zou W, Sandler A, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, McCleland M, Mocci S, Jassem J, Spigel DR. Atezolizumab for First-Line Treatment of PD-L1-Selected Patients with NSCLC. N Engl J Med. 2020 Oct 1;383(14):1328-1339. doi: 10.1056/NEJMoa1917346. |
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Study is considered 'Completed' because all of the criteria for End of Study have been met. Participants in survival follow-up completed their last visit and participants on active treatment were rolled over to a rollover study to continue their treatment.
Recruitment included: Japan (16 centers), Spain (15 centers), Greece (12 centers), Italy (12 centers), Brazil (11 centers), Russian (11 centers), France (10 centers), United States of America (9 centers), Ukraine (8 centers), Romania (7 centers), Turkey (6 centers), Poland (5 centers), Serbia (5 centers), Hungary (4 centers), Thailand (4 centers), Great Britain (3 centers), Republic of Korea (3 centers), Germany (2 centers), China (1 center).
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| ID | Title | Description |
|---|---|---|
| FG000 | Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months). |
| 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 | Feb 8, 2020 | Jan 26, 2021 |
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|
| Carboplatin | Drug | Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) 6 when given in combination with pemetrexed or at a dose of AUC 5 when given in combination with gemcitabine, every 21 days for 4 or 6 cycles as per local standard of care. |
|
| Cisplatin | Drug | Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (mg/m^2) every 21 days for 4 or 6 cycles as per local standard of care. |
|
| Gemcitabine | Drug | Gemcitabine will be administered as intravenous infusion at a dose of 1250 mg/m^2 (in combination with cisplatin) or 1000 mg/m^2 (in combination with carboplatin), on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles as per local standard of care. |
|
| Pemetrexed | Drug | Pemetrexed will be administered as intravenous infusion at a dose of 500 mg/m^2 on Day 1 of each 21-day cycle as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
| Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested. | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months) |
| Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations | Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1. | Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months) |
| Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1. | Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months) |
| Duration of Response (DOR) in the TC3 or IC3-WT Populations | DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. | From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
| Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. | From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months) |
| Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations | Baseline to 1 year or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
| Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations | Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
| Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | Baseline to 1 year or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months) |
| Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | Baseline to 2 years or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months) |
| Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations | TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant. | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) |
| Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations | Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant. | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) |
| TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations | TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea [multi-item scale], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) |
| OS in Participants With PD-L1 Expression | OS is defined as the time from randomization to death from any cause. | From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) |
| Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1 | Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay) | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
| OS in Participants With Blood Tumor Mutational Burden (bTMB) | OS is defined as the time from randomization to death from any cause. | From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) |
| Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1 | PFS according to RECIST v1.1 in the bTMB subpopulations. | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
| Minimum Observed Serum Concentration (Cmin) of Atezolizumab | Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, and at treatment discontinuation until data cut-off on 10 September 2018 (up to approximately 38 months) (cycle duration = 21 days) |
| Maximum Observed Serum Concentration (Cmax) of Atezolizumab | 0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour) |
| Percentage of Participants With at Least One Adverse Event | Percentage of participants with at least one adverse event. | Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months) |
| Percentage of Participants With Anti-therapeutic Antibodies (ATAs) | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Lynn Cancer Institute - West | Boca Raton | Florida | 33428 | United States |
| University of Maryland Greenebaum Cancer Center | Baltimore | Maryland | 21201 | United States |
| Oregon Health & Science Uni | Portland | Oregon | 97239 | United States |
| Sarah Cannon Cancer Center | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center; Multiple Sclerosis Center | Nashville | Tennessee | 37204 | United States |
| Hematology Oncology Associates of Fredericksburg, Inc. | Fredericksburg | Virginia | 22408 | United States |
| VA Puget Sound Health Care Sys | Seattle | Washington | 98108 | United States |
| Centro de Pesquisas Clinicas em Oncologia - CPCO | Cachoeiro de Itapemirim | Espírito Santo | 29308-014 | Brazil |
| Oncovida*X | Salvador | Estado de Bahia | 41820-021 | Brazil |
| Instituto Nacional de Cancer - INCa; Oncologia | Rio de Janeiro | Rio de Janeiro | 20560-120 | Brazil |
| Associacao Hospital de Caridade Ijui*X; Departamento De Oncologia | Ijuí | Rio Grande do Sul | 98700-000 | Brazil |
| Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia | Passo Fundo | Rio Grande do Sul | 99010-260 | Brazil |
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Instituto Joinvilense de Hematologia E Oncologia | Joinville | Santa Catarina | 89201-260 | Brazil |
| *X*Fundacao PIO XII | Barretos | São Paulo | 14784-400 | Brazil |
| Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira | São Paulo | São Paulo | 01246 000 | Brazil |
| Hospital Santa Marcelina | São Paulo | São Paulo | 08270-070 | Brazil |
| Harbin Medical University Tumor Hospital | Harbin | 150081 | China |
| CHU Angers | Angers | 49933 | France |
| Hospital d Instructions des Armees Percy | Clamart | 92141 | France |
| Hôpital Universitaire Dupuytren | Limoges | 87042 | France |
| Clinique Clémentville | Montpellier | 34070 | France |
| Centre D'oncologie de Gentilly | Nancy | 54100 | France |
| Hopital Tenon | Paris | 75020 | France |
| Centre Hospitalier Regional La Reunion Site Felix Guyon | Saint-Denis | 97405 | France |
| Hopital d'Instruction des Armees de Begin | Saint-Mandé | 94160 | France |
| Centre Hospitalier Regional Sud Reunion | Saint-Pierre | 97448 | France |
| Centre Paul Strauss | Strasbourg | 67000 | France |
| Asklepios-Fachklinik Muenchen-Gauting; Klinik Für Pneumologie | Gauting | 82131 | Germany |
| Pius-Hospital Oldenburg | Oldenburg | 26121 | Germany |
| Sotiria Chest Hospital of Athens | Athens | 11527 | Greece |
| IASO General Hospital of Athens | Athens | 155 62 | Greece |
| Metropolitan Hospital | Athens | 185 47 | Greece |
| Attikon University General Hospital | Chaïdári | 124 62 | Greece |
| University General Hospital of Larissa | Larissa | 412 21 | Greece |
| University General Hospital of Patras | Pátrai | 265 00 | Greece |
| Thermi Clinic | Thermi, Thessaloniki | 57001 | Greece |
| Bioclinic Thessaloniki | Thessaloniki | 546 22 | Greece |
| EUROMEDICA General Clinic of Thessaloniki; Gastroenterology Department | Thessaloniki | 54645 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | 564 29 | Greece |
| Georgios Papanikolaou General Hosp. of Thessaloniki | Thessaloniki | 57010 | Greece |
| Uzsoki Utcai Korhaz | Budapest | 1145 | Hungary |
| Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz | Nyíregyháza | 4400 | Hungary |
| Pecsi Tudomanyegyetem | Pécs | 7624 | Hungary |
| Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont | Szolnok | 5004 | Hungary |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | 47014 | Italy |
| Centro Di Riferimento Oncologico; Struttura Operativa Complessa Di Oncologia Medica B | Aviano | Friuli Venezia Giulia | 33081 | Italy |
| Asst Papa Giovanni XXIII | Bergamo | Lombardy | 24100 | Italy |
| Azienda Ospedaliera Istituti Ospitalieri | Cremona | Lombardy | 26100 | Italy |
| Ospedale San Raffaele S.r.l. | Milan | Lombardy | 20132 | Italy |
| Istituto Europeo Di Oncologia | Milan | Lombardy | 20141 | Italy |
| Azienda Socio Sanitaria Territoriale ? ASST di Monza | Monza | Lombardy | 20052 | Italy |
| Istituto Nazionale dei Tumori | Monza | Lombardy | 20052 | Italy |
| Istituto Clinico Humanitas | Rozzano (MI) | Lombardy | 20089 | Italy |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Turin | Piedmont | 10126 | Italy |
| Azienda Ospedaliero-Universitaria ?PoliclinicoVittorio Emanuele?- P.O. G. Rodolico; Oncologia Medica | Catania | Sicily | 95123 | Italy |
| Azienda Ospedaliera Universitaria Integrata Verona; UOC Oncologia | Verona | Veneto | 37126 | Italy |
| Aichi Cancer Center Hospital; Respiratory Medicine | Aichi | 464-8681 | Japan |
| Nagoya University Hospital; Respiratory Medicine | Aichi | 466-8560 | Japan |
| Kyushu University Hospital; Respiratory | Fukuoka | 812-8582 | Japan |
| Hokkaido University Hospital | Hokkaido | 060-8648 | Japan |
| Kobe City Medical Center General Hospital; Respiratory Medicine | Hyōgo | 650-0047 | Japan |
| Hyogo Cancer Center; Thoracic Oncology | Hyōgo | 673-8558 | Japan |
| Ibaraki Prefectural Central Hospital; Division of respiratory | Ibaraki | 309-1793 | Japan |
| Sendai Kousei Hospital; Pulmonary Medicine | Miyagi | 980-0873 | Japan |
| Okayama University Hospital; Respiratory and Allergy Medicine | Okayama | 700-8558 | Japan |
| Osaka International Cancer Institute; Thoracic Oncology | Osaka | 541-8567 | Japan |
| Kansai Medical university Hospital; Thoracic Oncology | Osaka | 573-1191 | Japan |
| Osaka Habikino Medical Center | Osaka | 583-8588 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Sakaishi | 591-8555 | Japan |
| Saitama Cancer Center; Thoracic Oncology | Satima | 362-0806 | Japan |
| National Cancer Center Hospital; Thoracic Medical Oncology | Tokyo | 104-0045 | Japan |
| Tokyo Medical University Hospital; Dept of Surgery | Tokyo | 160-0023 | Japan |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland |
| Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie; Oddzial onkologii z pododdzialem chemioterapii | Olsztyn | 10-357 | Poland |
| Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy | Otwock | 05-400 | Poland |
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu | Poznan | 60-569 | Poland |
| Med-Polonia Sp. z o.o. | Poznan | 60-693 | Poland |
| Teo Health SA - Saint Constantin Hospital | Brasov | 500091 | Romania |
| Prof. Dr. I. Chiricuta Institute of Oncology | Cluj-Napoca | 400015 | Romania |
| Oncology Center Sf. Nectarie | Craiova | 200347 | Romania |
| Institutul Regional de Oncologie Iasi; Clinica de Hematologie | Iași | 700483 | Romania |
| Sibiu Emergency Clinical County Hospital | Sibiu | 550245 | Romania |
| Oncocenter Clinical Oncology | Timi?oara | 300210 | Romania |
| Oncomed SRL | Timișoara | 300239 | Romania |
| Arkhangelsk Regional Clinical Oncology Dispensary | Arkhangelsk | Arhangelsk | 163045 | Russia |
| Federal State Institution Medical Radiology Research Center | Obninsk | Kaluga Oblast | 249036 | Russia |
| Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moscow Oblast | 143423 | Russia |
| Principal Military Clinical Hospital n.a. N.N. Burdenko | Moscow | Moscow Oblast | 105229 | Russia |
| Saint Petersburg Clinical Hospital of the Russian Academy of Sciences | Saint Petersburg | Sankt-Peterburg | 194017 | Russia |
| Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic | Kazan' | Tatarstan Republic | 420029 | Russia |
| Regional Clinical Oncology Center | Ryazan | 390046 | Russia |
| Leningrad Regional Clinical Hospital | Saint Petersburg | 194291 | Russia |
| St. Petersburg Med Univ; n.a. I.P. Pavlov; Pulmonology Research | Saint Petersburg | 197089 | Russia |
| Mordovia State University | Saransk | 430032 | Russia |
| Volgograd Regional Clinical Oncology Dispensary | Volgograd | 400138 | Russia |
| Clinical Center of Serbia | Belgrade | 11000 | Serbia |
| Institute for Oncology and Radiology of Serbia; Medical Oncology | Belgrade | 11000 | Serbia |
| Institute of Lung Diseases Vojvodina | Kamenitz | 21204 | Serbia |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Chonnam National University Hwasun Hospital | Jeollanam-do | 58128 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13620 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Hospital Universitario Son Espases | Palma de Mallorca | Balearic Islands | 07010 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Balearic Islands | 07198 | Spain |
| Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Badalona | Barcelona | 08916 | Spain |
| Consorcio Hospitalario Provincial de Castellon | Castellon de LA Plana/castello de LA Plana | Castellon | 12002 | Spain |
| Hospital Universitario A Coruña | A Coruña | LA Coruña | 15006 | Spain |
| Hospital Universitario Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Hospital Universitario Vall d'Hebron - PPDS | Barcelona | 08035 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Hospital Clinico San Carlos; Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Hosp Clinico Univ Lozano Blesa; División De Oncología Médica | Zaragoza | 50009 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Prince of Songkla University; Department Of Internal Medicine, Faculty Of Medicine | Hat Yai | 90110 | Thailand |
| Khon Kaen University | Khon Kaen | 40002 | Thailand |
| Chiang Rai Prachanukroh Hospital | Muang | 57000 | Thailand |
| Buddhachinnaraj Hospital | Phitsanulok | 65000 | Thailand |
| Cukurova University Medical Faculty Balcali Hospital | Adana | 1330 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | 06100 | Turkey (Türkiye) |
| Istanbul University Cerrahpasa Medical Faculty | Istanbul | 34000 | Turkey (Türkiye) |
| Ege Universitesi Tip Fakultesi Hastanesi | Izmir | 35100 | Turkey (Türkiye) |
| Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi | Izmir | 35110 | Turkey (Türkiye) |
| Inonu University Faculty of Medicine Turgut Ozal Medical Center | Malatya | 44280 | Turkey (Türkiye) |
| Municipal Noncommercial Institution Regional Center of Oncology | Kharkiv | Kharkiv Governorate | 61070 | Ukraine |
| Municipal Noncomercial Enterprise Odessa Regional Oncology Center ofthe Odessa StateAdministration | Odesa | Kherson Governorate | 65055 | Ukraine |
| Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp | Sumy | Kholm Governorate | 40005 | Ukraine |
| Communal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council - PPDS; Chemotherapy | Dnipro | KIEV Governorate | 49102 | Ukraine |
| Kyiv Railway Clinical Hospital #3 of Branch Health Center of the PJSC Ukrainian Railway | Kyiv | KIEV Governorate | 02096 | Ukraine |
| Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council | Vinnytsia | KIEV Governorate | 21029 | Ukraine |
| The Municipal Enterprise Volyn Regional Medical Oncology Centre of the Volyn Regional Council | Lutsk | Volhynian Governorate | 43018 | Ukraine |
| Private Enterprise Private Manufacturing Company Acinus | Kirovograd | 25006 | Ukraine |
| Birmingham Heartlands Hospital | Birmingham | B9 5SS | United Kingdom |
| Colchester General Hospital | Colchester, Essex | CO4 5JL | United Kingdom |
| Christie Hospital | Manchester | M20 3BG | United Kingdom |
| FG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months). |
| BG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) in the TC3 or IC3-WT Populations | OS is defined as the time from randomization to death from any cause. | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Median | 95% Confidence Interval | Months | From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | OS is defined as the time from randomization to death from any cause. | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Median | 95% Confidence Interval | Months | From randomization to death from any cause until data cut-off on 4 February 2020 (up to approximately 54.5 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in the TC3 or IC3-WT Populations | PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested. | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | 95% Confidence Interval | Months | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | PFS is defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. PFS could not be formally tested. | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | 95% Confidence Interval | Months | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (ORR) in the TC3 or IC3-WT Populations | Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1. | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | Percentage of participants | Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 10 Sep 2018 (up to approximately 38 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Objective Response (ORR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | Objective response (partial response plus complete response) as determined by the investigator according to RECIST v1.1. | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | Percentage of participants | Every 6 weeks for 48 weeks following Day 1, thereafter every 9 weeks after completion of Week 48 tumor assessment, regardless of treatment delays, until radiographic disease progression until data cut-off on 4 Feb 2020 (up to approximately 54.5 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) in the TC3 or IC3-WT Populations | DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | 95% Confidence Interval | Months | From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | DOR is defined as the time from the first occurrence of a documented objective response to the time of disease progression, as determined by the investigator with use of RECIST v1.1, or death from any cause, whichever occurs first. | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | 95% Confidence Interval | Months | From first occurrence of a complete response or partial response, whichever occurs first, until first date that progressive disease or death is documented, whichever occurs first until data cut-off on 4 February 2020 (up to approximately 54.5 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Are Alive at 1 Year in the TC3 or IC3-WT Populations | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to 1 year or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Are Alive at 2 Years in the TC3 or IC3-WT Populations | Analysis was performed for the TC3 or IC3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to 2 years or death, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Are Alive at 1 Year in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to 1 year or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Are Alive at 2 Years in the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT Populations | Analysis was performed for the TC2/3 or IC2/3-WT and TC1/2/3 or IC1/2/3-WT populations. Comparison of the treatment arms was performed in randomized participants who were selected on the basis of a minimum level of PD-L1 expression on tumor cells (TCs) and/or immune cells (ICs) with populations excluding participants with a sensitizing EGFR mutation or ALK translocation (i.e., wild type [WT]). | Posted | Number | 95% Confidence Interval | Percentage of participants | Baseline to 2 years or death, whichever occurs first until clinical cut-off date on 4 February 2020 (up to approximately 54.5 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Deterioration (TTD) in Patient-reported Lung Cancer Symptoms Score as Assessed by the Symptoms in Lung Cancer (SILC) Scale Symptom Score in the TC3 or IC3-WT Populations | TTD in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant. | Analysis was performed for the TC3 or IC3-WT Populations. | Posted | Median | 95% Confidence Interval | Months | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Patient-reported Lung Cancer Symptoms Score as Assessed by the SILC Scale Symptom Score in the TC3 or IC3-WT Populations | Change from baseline in each of the patient-reported lung cancer symptoms with use of the SILC scale. The SILC scale is a nine-item content valid self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a total symptom severity score. Each SILC symptom scale (dyspnea, cough, chest pain) score was calculated as the average of the component items (range 0 to 4). An increase in score suggested worsening in symptomatology. A symptom score change of 0.3 points for the dyspnea and cough scores was considered to be clinically significant; whereas a symptom score change of 0.5 points for the chest pain score was considered to be clinically significant. | Analysis was performed for the TC3 or IC3-WT Populations. | Posted | Mean | Standard Deviation | Score on a scale | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | TTD as Assessed Using EORTC QLQ Supplementary Lung Cancer Module (EORTC QLQ-LC13) in the TC3 or IC3-WT Populations | TTD in patient-reported lung cancer symptoms, defined as time from randomization to deterioration (10-point change) in any of the following symptom subscales (cough, dyspnea [multi-item scale], and chest pain), whichever occurs first, as measured by the EORTC QLQ-LC13. EORTC QLQ-LC13 module incorporates one multi-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. | Analysis was performed for the TC3 or IC3-WT Populations. | Posted | Median | 95% Confidence Interval | Months | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS in Participants With PD-L1 Expression | OS is defined as the time from randomization to death from any cause. | Analysis was performed for participants with PD-L1 Expression of PD-L1 status by SP263 >=50%, SP263 >=25%, SP263 >=1% in the Intent-to-Treat Wild Type Population. | Posted | Median | 95% Confidence Interval | Months | From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) |
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| Secondary | Investigator-Assessed PFS in Participants With PD-L1 Expression According to RECIST v1.1 | Investigator-assessed PFS according to RECIST v1.1 in the PD-L1 (defined with SP263 IHC assay) | Analysis was performed for participants with PD-L1 Expression of PD-L1 status by SP263 >=50%, SP263 >=25%, SP263 >=1% in the Intent-to-Treat Wild Type Population. | Posted | Median | 95% Confidence Interval | Months | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
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| Secondary | OS in Participants With Blood Tumor Mutational Burden (bTMB) | OS is defined as the time from randomization to death from any cause. | Analysis was performed for the bTMB subpopulations in the Intent-to-Treat Wild Type population. | Posted | Median | 95% Confidence Interval | Months | From randomization to death from any cause until data cut-off on 10 September 2018 (up to approximately 38 months) |
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| Secondary | Investigator-Assessed PFS in Participants With bTMB According to RECIST v1.1 | PFS according to RECIST v1.1 in the bTMB subpopulations. | Analysis was performed for participants with bTMB >=10 Intent-to-treat Wild Type Population. | Posted | Median | 95% Confidence Interval | Months | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first until data cut-off on 10 September 2018 (up to approximately 38 months) |
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| Secondary | Minimum Observed Serum Concentration (Cmin) of Atezolizumab | PK analyses was based on PK observations from all randomized participants who received atezolizumab and provided at least one PK sample that was evaluable. | Posted | Mean | Standard Deviation | micrograms per milliliter (μg/ mL) | Prior to infusion (0 hour) on Day 1 of Cycles 2, 3, 4, 8, 16, and every eighth cycle thereafter, and at treatment discontinuation until data cut-off on 10 September 2018 (up to approximately 38 months) (cycle duration = 21 days) |
|
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Atezolizumab | PK analyses was based on PK observations from all randomized participants who received atezolizumab and provided at least one PK sample that was evaluable. | Posted | Mean | Standard Deviation | micrograms per milliliter (μg/ mL) | 0 hour (predose) and 30 minutes after atezolizumab infusion on Day 1 (infusion duration = up to 1 hour) |
|
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| Secondary | Percentage of Participants With at Least One Adverse Event | Percentage of participants with at least one adverse event. | Safety analyses included treated participants, defined as randomized participants who received any amount of study treatment. | Posted | Number | Percentage of participants | Baseline up to until data cut-off on 8 March 2022 (up to approximately 79.5 months) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Anti-therapeutic Antibodies (ATAs) | The baseline ADA-evaluable population included participants who had a baseline ADA result and had received at least one dose of atezolizumab. The post-baseline ADA evaluable population included participants who had at least one post-baseline ADA result and had received at least one dose of atezolizumab. | Posted | Number | Percentage of participants | Baseline until data cut-off on 10 September 2018 (up to approximately 38 months) |
|
|
From the first study drug until the data cut-off on 8 March 2022 (up to approximately 79.5 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious & other adverse events reported based on safety population, which included participants who received any amount of any study drug.
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 | Chemotherapy (Carboplatin/ Cisplatin) + (Pemetrexed/ Gemcitabine) | Participants with non-squamous NSCLC will receive chemotherapy with pemetrexed in combination with either cisplatin or carboplatin (per investigator discretion) on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by maintenance therapy with pemetrexed alone as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months). Participants with squamous NSCLC will receive chemotherapy with gemcitabine on Days 1 and 8 of each 21-day cycle in combination with either cisplatin or carboplatin on Day 1 of each 21-day cycle for 4 or 6 cycles as per local standard of care, followed by best supportive care as per local standard of care until disease progression, unacceptable toxicity, or death (maximum up to approximately 58 months). | 211 | 287 | 77 | 263 | 230 | 263 |
| EG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). | 201 | 285 | 97 | 286 | 238 | 286 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Thrombocytosis | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Autoimmune myocarditis | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Glucocorticoid deficiency | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Autoimmune colitis | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Gastrointestinal motility disorder | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Mechanical ileus | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Haemophagocytic lymphohistiocytosis | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Immune system disorder | Immune system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Mycotic endophthalmitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pleural infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA Version 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| Carotid arteriosclerosis | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Neurological decompensation | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA Version 24.1 | Systematic Assessment |
| |
| Thrombosis in device | Product Issues | MedDRA Version 24.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Ketonuria | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Autoimmune dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Bacterial colitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Biliary neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Post-acute COVID-19 syndrome | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Langerhans' cell histiocytosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA Version 24.1 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Vein disorder | Vascular disorders | MedDRA Version 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA Version 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 24.1 | 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 | Apr 2, 2019 | Jan 26, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D016190 | Carboplatin |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
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 |
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| Atezolizumab |
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| Atezolizumab |
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
| OG001 | Atezolizumab | Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
|
|
|
Participants with squamous or non-squamous NSCLC will receive atezolizumab on Day 1 of each 21-day cycle until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months). |
|
|
|
|
|
|
|
|
|
|
|
|
|
|