Carcinoma, Non-Small-Cell Lung Clinical Trial
— IMpower150Official title:
A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
| Verified date | August 2021 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This randomized, open-label study evaluated the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 [PD-L1] antibody) in combination with carboplatin+paclitaxel with or without bevacizumab compared with treatment with carboplatin+paclitaxel+bevacizumab in chemotherapy-naïve participants with Stage IV non-squamous NSCLC. Participants were randomized in a 1:1:1 ratio to Arm A (Atezolizumab+Carboplatin+Paclitaxel), Arm B (Atezolizumab+Carboplatin+Paclitaxel+Bevacizumab), or Arm C (Carboplatin+Paclitaxel+Bevacizumab).
| Status | Completed |
| Enrollment | 1202 |
| Est. completion date | December 7, 2020 |
| Est. primary completion date | September 13, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Eastern Cooperative Oncology Group performance status 0 or 1 - Histologically or cytologically confirmed, Stage IV non-squamous NSCLC - Participants with no prior treatment for Stage IV non-squamous NSCLC - Known PD-L1 status as determined by immunohistochemistry assay performed on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening - Measurable disease as defined by RECIST v1.1 - Adequate hematologic and end organ function Exclusion Criteria: Cancer-Specific Exclusions: - Active or untreated central nervous system metastases - Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome General Medical Exclusions: - Pregnant or lactating women - History of autoimmune disease - History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted - Positive test for human immunodeficiency virus - Active hepatitis B or hepatitis C - Severe infection within 4 weeks prior to randomization - Significant cardiovascular disease - Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures Exclusion Criteria Related to Medications: - Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Medico Austral | Buenos Aires | |
| Argentina | Fundación CENIT para la Investigación en Neurociencias | Buenos Aires | |
| Argentina | Sanatorio Allende | Cordoba | |
| Argentina | Centro Oncologico Riojano Integral (CORI) | La Rioja | |
| Argentina | Hospital Provincial del Centenario | Rosario | |
| Argentina | Fundacion Koriza | Santa Rosa | |
| Argentina | Centro de Investigacion; Clinica - Clinica Viedma S.A. | Viedma | |
| Australia | Royal Adelaide Hospital | Adelaide | South Australia |
| Australia | Chris O'Brien Lifehouse | Camperdown | New South Wales |
| Australia | Prince Charles Hospital; Department of Medical Oncology | Chermside | Queensland |
| Australia | Concord Repatriation General Hospital | Concord | New South Wales |
| Australia | Frankston Hospital | Frankston | Victoria |
| Australia | Austin Health | Heidelberg | Victoria |
| Australia | Royal Hobart Hospital | Hobart | Tasmania |
| Australia | Adelaide Cancer Centre | Kurralta Park | South Australia |
| Australia | Launceston General Hospital | Launceston | Tasmania |
| Australia | Cabrini Hospital Malvern | Malvern | Victoria |
| Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
| Australia | The Alfred Hospital | Prahan | Victoria |
| Australia | Sunshine Hospital | St Albans | Victoria |
| Australia | Nepean Cancer Care Centre | Sydney | New South Wales |
| Australia | Townsville Hospital | Townsville | Queensland |
| Australia | Princess Alexandra Hospital | Woolloongabba | Queensland |
| Austria | Paracelsus Medizinische Privatuniversität | Salzburg | |
| Austria | Klinikum Wels-Grieskirchen | Wels | |
| Belgium | CHU de Liège | Liège | |
| Belgium | Clinique Ste-Elisabeth | Namur | |
| Brazil | Hospital de Cancer de Barretos | Barretos | SP |
| Brazil | IPCEM; Instituto de Pesquisa de Estudos Multicêntricos | Caxias do Sul | RS |
| Brazil | Instituto Do Cancer Delondrina_X; Unidade De Pesquisa Clinica | Londrina | PR |
| Brazil | Liga Norte Riograndense Contra O Câncer | Natal | RN |
| Brazil | Hospital Mae de Deus | Porto Alegre | RS |
| Brazil | Instituto Ribeirãopretano de Combate Ao Câncer; Centro Especializado De Oncologia | Ribeirão Preto | SP |
| Brazil | Hospital de Base de Sao Jose do Rio Preto | Sao Jose do Rio Preto | SP |
| Brazil | Hospital A. C. Camargo; Oncologia | Sao Paulo | SP |
| Brazil | CETUS Hospital Dia Oncologia | Uberaba | MG |
| Bulgaria | Multiprofile Hospital for Active Treatment Central Onco Hospital OOD | Plovdiv | |
| Bulgaria | MHAT Serdika, EOOD | Sofia | |
| Canada | Lakeridge Health Center | Oshawa | Ontario |
| Chile | Clinica Santa Maria | Santiago | |
| Chile | Health & Care SPA | Santiago | |
| Chile | Sociedad de Investigaciones Medicas Ltda (SIM) | Temuco | |
| France | Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest | Bordeaux | |
| France | CHU de Grenoble | Grenoble | |
| France | Centre Jean Bernard Clinique Victor Hugo | Le Mans | |
| France | Hopital Nord AP-HM | Marseille | |
| France | Hôpital Saint Joseph | Marseille | |
| France | Hôpital Européen Georges Pompidou | Paris | |
| France | CHU de Bordeaux | Pessac | |
| France | Service de Pneumologie Centre Hospitalier Régional La Réunion Site Felix Guyon | Saint Denis Cedex | |
| France | CH de Saint Quentin | Saint Quentin | |
| France | Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer | Toulon | |
| France | Hôpital d'Instruction des Armées de Sainte Anne; Service de Pneumologie | Toulon | |
| France | Hôpital Larrey;Université Paul Sabatier | Toulouse | |
| Germany | Zentralklinikum Augsburg | Augsburg | |
| Germany | Helios Klinikum Emil von Behring GmbH | Berlin | |
| Germany | Ev.Krankenhaus Bielefeld gGmbH; Klinik für Innere Medizin und Geriatrie | Bielefeld | |
| Germany | Augusta Kranken-Anstalt gGmbH | Bochum | |
| Germany | Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden | Dresden | |
| Germany | St. Elisabethen Krankenhaus | Frankfurt am Main | |
| Germany | LungenClinic Großhansdorf GmbH | Großhansdorf | |
| Germany | Krankenhaus Martha-Maria; Halle-Dolau gGmbH | Halle | |
| Germany | Asklepios Klinik Harburg | Hamburg | |
| Germany | Lungenklinik Hemer | Hemer | |
| Germany | Universität Des Saarlandes; Klinik für Innere Medizin V | Homburg | |
| Germany | Kliniken der Stadt Koln gGmbH; Lungenklinik Onkologische Ambulanz | Koln | |
| Germany | Klinik Loewenstein gGmbH; Onk & Pal | Loewenstein | |
| Germany | Klinikum Bogenhausen | München | |
| Germany | Klinikum der Universität Regensburg | Regensburg | |
| Germany | Krankenhaus Barmherzige Bruder Regensburg | Regensburg | |
| Germany | Stiftung Mathias-Spital Rheine | Rheine | |
| Italy | Policlinico Vittorio Emanuele | Catania | Sicilia |
| Italy | ASL 3 Genovese; DSM | Genova | Liguria |
| Italy | Istituto Nazionale per la Ricerca sul Cancro di Genova | Genova | Liguria |
| Italy | Ospedale Versilia | Lido Di Camaiore | Toscana |
| Italy | Ospedale Civile - Livorno | Livorno | Toscana |
| Italy | AORN A Cardarelli | Napoli | Campania |
| Italy | A.O.U. Maggiore della Carità | Novara | Piemonte |
| Italy | Azienda Ospedaliera San Camillo Forlanini | Roma | Lazio |
| Italy | Policlinico Universitario Campus Biomedico; Uoc Oncologia Medica | Roma | Lazio |
| Italy | Università Cattolica Del S Cuore | Roma | Lazio |
| Italy | Azienda Unita Sanitaria Locale N1 Sassari; Unita Operativa Di Oncologia Medica | Sassari | Sardegna |
| Japan | National Hospital Organization Shikoku Cancer Center | Ehime | |
| Japan | Kurume University Hospital | Fukuoka | |
| Japan | National Hospital Organization Kyushu Medical Center | Fukuoka | |
| Japan | NHO Kyushu Cancer Center | Fukuoka | |
| Japan | Kanagawa Cardiovascular and Respiratory Center | Kanagawa | |
| Japan | Kitasato University Hospital | Kanagawa | |
| Japan | Kyoto University Hospital | Kyoto | |
| Japan | Miyagi Cancer Center | Miyagi | |
| Japan | Niigata Cancer Center Hospital | Niigata | |
| Japan | National Hospital Organization Osaka Toneyama Medical Center | Osaka | |
| Japan | Osaka City University Hospital | Osaka | |
| Japan | Center Hospital of the National Center for Global Health and Medicine | Tokyo | |
| Japan | Kyorin University Hospital | Tokyo | |
| Japan | Toranomon Hospital | Tokyo | |
| Japan | Wakayama Medical University Hospital | Wakayama | |
| Latvia | Pauls Stradins Clinical University Hospital | Riga | |
| Latvia | Riga East Clinical University Hospital Latvian Oncology Centre | Riga | |
| Lithuania | National Cancer Institute | Vilnius | |
| Mexico | Centro Universitario Contra El Cancer | Monterrey | |
| Mexico | Cancerologia de Queretaro | Queretaro | |
| Mexico | Centro Hemato Oncologico Privado; Oncologia | Toluca | |
| Netherlands | Jeroen Bosch Ziekenhuis | 'S Hertogenbosch | |
| Netherlands | Amsterdam UMC Location VUMC | Amsterdam | |
| Netherlands | Amphia Ziekenhuis; Afdeling Longziekten | Breda | |
| Netherlands | Ziekenhuis Gelderse Vallei | EDE | |
| Netherlands | Tergooiziekenhuizen | Hilversum | |
| Netherlands | Spaarne Gasthuis; Spaarne Ziekenhuis | Hoofddorp | |
| Netherlands | Maastricht University Medical Center | Maastricht | |
| Netherlands | St. Antonius Ziekenhuis; R&D Long | Nieuwegein | |
| Netherlands | Erasmus MC; Afdeling Longziekten | Rotterdam | |
| Netherlands | Maasstad ziekenhuis | Rotterdam | |
| Netherlands | Universitair Medisch Centrum Utrecht | Utrecht | |
| Netherlands | Gelre Ziekenhuizen, Zutphen | Zutphen | |
| Peru | Centro Especializado de Enfermedades Neoplásicas | Arequipa | |
| Peru | Centro Medico Monte Carmelo | Arequipa | |
| Peru | Instituto Nacional de Enfermedades Neoplasicas | Lima | |
| Portugal | Centro Hospitalar E Universitário de Coimbra EPE | Coimbra | |
| Portugal | Hospital Pulido Valente; Servico de Pneumologia | Lisboa | |
| Portugal | Instituto Portugues Oncologia de Lisboa Francisco Gentil EPE | Lisboa | |
| Portugal | Centro Hospitalar do Porto - Hospital de Santo António | Porto | |
| Portugal | Hospital de Sao Joao; Servico de Pneumologia | Porto | |
| Portugal | Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe | Porto | |
| Russian Federation | Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moskovskaja Oblast |
| Russian Federation | Russian Oncology Research Center n.a. N.N. Blokhin | Moscow | |
| Russian Federation | Clinical Oncology Dispensary | Omsk | |
| Russian Federation | Evromedservis LCC | Pushkin | |
| Russian Federation | City Clinical Oncology Dispensary | Saint-Petersburg | |
| Singapore | National Cancer Centre; Medical Oncology | Singapore | |
| Slovakia | Narodny onkologicky ustav | Bratislava | |
| Slovakia | Univerzitna nemocnica Bratislava | Bratislava | |
| Slovakia | POKO Poprad s.r.o. | Poprad | |
| Spain | Hospital Clinic de Barcelona | Barcelona | |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | |
| Spain | Hospital Universitario Reina Sofia | Cordoba | |
| Spain | Instituto Catalan de Oncologia de Hospitalet (ICO); Servicio de Farmacia | L'Hospitalet de Llobregat | Barcelona |
| Spain | Hospital Universitario Insular de Gran Canaria | Las Palmas de Gran Canaria | LAS Palmas |
| Spain | Hospital Lucus Augusti; Servicio de Oncologia | Lugo | |
| Spain | Hospital Clinico San Carlos; Servicio de Oncologia | Madrid | |
| Spain | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | |
| Spain | Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario Fundación Jimenez Díaz | Madrid | |
| Spain | Hospital Universitario HM Sanchinarro-CIOCC | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Complejo Hospitalario U. de Ourense | Ourense | Orense |
| Spain | Hospital Universitario Son Espases | Palma De Mallorca | Islas Baleares |
| Spain | Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | Cantabria |
| Spain | Hospital Clinico Universitario de Valencia | Valencia | |
| Spain | Hospital Lluis Alcanyis De Xativa | Xativa | Valencia |
| Switzerland | Kantonsspital Baselland | Bruderholz | |
| Switzerland | Luzerner Kantonsspital Sursee | Luzern | |
| Switzerland | Kantonsspital St. Gallen; Onkologie/Hämatologie | St. Gallen | |
| Taiwan | Changhua Christian Hospital; Hematology-Oncology | Changhua | |
| Taiwan | Kaohsiung Medical University Hospital; Department of Urology | Kaohsiung City | |
| Taiwan | Chi Mei Medical Center Liou Ying Campus | Liuying Township | |
| Taiwan | Chang Gung Memorial Hospital Chiayi | Putzu | |
| Taiwan | National Cheng Kung Univ Hosp | Tainan | |
| Taiwan | Cheng Hsin General Hospital | Taipei | |
| Taiwan | Tri-Service General Hospital | Taipei | |
| Taiwan | National Taiwan Uni Hospital | Taipei City | |
| Taiwan | Chang Gung Medical Foundation Linkou Branch | Taoyuan City | |
| Taiwan | Taichung Veterans General Hospital | Xitun Dist. | |
| Ukraine | ME Bukovinian Clinical Oncology Center | Chernivtsi | Chernihiv Governorate |
| Ukraine | Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS; Dept of Chemotherapy | Dnipropetrovsk | Katerynoslav Governorate |
| Ukraine | Municipal Institution SubCarpathian Clinical Oncological Centre; Surgical department#2 | Ivano-Frankivsk | KIEV Governorate |
| Ukraine | Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs | Kharkiv | Kharkiv Governorate |
| Ukraine | SI Institute of Medical Radiology n.a. S.P. Hryhoriev of NAMS of Ukraine | Kharkiv | |
| Ukraine | ME Kryviy Rih Oncology Dispensary of Dnipropetrovs'k Regional Council; Chemotherapy Department | Kryvyi Rih | |
| Ukraine | Kyiv City Clinical Oncological Center | Kyiv | |
| Ukraine | Poltava Regional Clinical Oncology Dispensary of Poltava Regional Council; Thoracic department | Poltava | |
| Ukraine | Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary | Sumy | |
| Ukraine | MNPE Transcarpathian Antitumor Center of the Transcarpathian Regional Council; Chemotherapy Dept | Uzhhorod | Kherson Governorate |
| Ukraine | Uzhgorod Central City Clinical Hospital | Uzhhorod | Katerynoslav Governorate |
| Ukraine | Communal Nonprofit Enterprise Podilsky Regional Center Of Oncology OfTheVinnytsia Regional Council | Vinnytsia | KIEV Governorate |
| Ukraine | MNPE Zaporizhzhia Regional Antitumor Center ZRC | Zaporizhzhia | Katerynoslav Governorate |
| United States | St. Joseph Mercy Health System | Ann Arbor | Michigan |
| United States | Piedmont Cancer Institute, PC | Atlanta | Georgia |
| United States | MultiCare Regional Cancer Center - Auburn | Auburn | Washington |
| United States | Mercy Medical Center | Baltimore | Maryland |
| United States | Southern CA Permanente Med Grp | Bellflower | California |
| United States | Bend Memorial Clinic | Bend | Oregon |
| United States | St. Charles Medical Center Bend; Cancer Care Of The Cascades | Bend | Oregon |
| United States | Summit Medical Group | Berkeley Heights | New Jersey |
| United States | Regional Cancer Care Associates | Bethesda | Maryland |
| United States | St. Luke's Cancer Care Associates | Bethlehem | Pennsylvania |
| United States | Hematology-Oncology; Associates of the Quad Cities | Bettendorf | Iowa |
| United States | Billings Clinic | Billings | Montana |
| United States | Montefiore Medical Center | Bronx | New York |
| United States | Maimonides Medical Center | Brooklyn | New York |
| United States | Ironwood Cancer & Research Centers | Chandler | Arizona |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Univ of Chicago | Chicago | Illinois |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | Maryland Oncology Hematology, P.A. | Columbia | Maryland |
| United States | Danbury Hospital | Danbury | Connecticut |
| United States | Rocky Mountain Cancer Center | Denver | Colorado |
| United States | St. Luke's Regional Cancer Center | Duluth | Minnesota |
| United States | Providence Regional Cancer Partnership | Everett | Washington |
| United States | Virginia Cancer Specialists, PC | Fairfax | Virginia |
| United States | Arizona Oncology Associates | Flagstaff | Arizona |
| United States | Holy Cross Hospital Inc | Fort Lauderdale | Florida |
| United States | West Clinic | Germantown | Tennessee |
| United States | Marin Cancer Care Inc | Greenbrae | California |
| United States | Ingalls Memorial Hospital | Harvey | Illinois |
| United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
| United States | Houston Methodist Cancer Center | Houston | Texas |
| United States | Cancer Specialists of North Florida - Baptist South | Jacksonville | Florida |
| United States | St. Luke's Cancer Institute | Kansas City | Missouri |
| United States | Tennessee Cancer Specialists | Knoxville | Tennessee |
| United States | Scripps Health | La Jolla | California |
| United States | Kaiser Permanente | Lonetree | Colorado |
| United States | Longview Cancer Center | Longview | Texas |
| United States | Norton Cancer Institute | Louisville | Kentucky |
| United States | Mount Sinai Medical Center | Miami Beach | Florida |
| United States | Montana Cancer Specialists | Missoula | Montana |
| United States | West Virginia University; Mary Babb Randolph Can Ctr | Morgantown | West Virginia |
| United States | Yale Cancer Center | New Haven | Connecticut |
| United States | Virginia Oncology Associates | Norfolk | Virginia |
| United States | Chao Family Comprehensive Cancer Center UCI | Orange | California |
| United States | Valley Hospital; Oncology Research | Paramus | New Jersey |
| United States | Oncology Specialists, S.C. | Park Ridge | Illinois |
| United States | First Health of the Carolinas | Pinehurst | North Carolina |
| United States | Allegheny Cancer Center | Pittsburgh | Pennsylvania |
| United States | Univ of Pittsburgh Medical Ctr | Pittsburgh | Pennsylvania |
| United States | Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida |
| United States | Virginia Cancer Institute | Richmond | Virginia |
| United States | Blue Ridge Cancer Care | Roanoke | Virginia |
| United States | Missouri Baptist Medical Center | Saint Louis | Missouri |
| United States | Park Nicolett - Frauenshuh Cancer Center | Saint Louis Park | Minnesota |
| United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
| United States | New England Cancer Specialists | Scarborough | Maine |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | Regional Cancer Care Associates LLC | Sewell | New Jersey |
| United States | Medical Oncology Associates | Spokane | Washington |
| United States | Willamette Valley Cancer Insitute and Research Center | Springfield | Oregon |
| United States | Mercy St Anne Hospital | Toledo | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, France, Germany, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Peru, Portugal, Russian Federation, Singapore, Slovakia, Spain, Switzerland, Taiwan, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression Free Survival (PFS), as Determined by the Investigator in Arm B Versus Arm C in the Teff-high WT Population and ITT-WT Population | Progression Free Survival (PFS), as Determined by the Investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population. | Baseline until disease progression or death, whichever occurs first until data cut-off on 15 September 2017 (up to approximately 29 months) | |
| Primary | Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population | Overall Survival (OS) in Arm B Versus Arm C in ITT-WT Population | Baseline until death until data cut-off on 22 January 2018 (up to approximately 34 months) | |
| Primary | Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population | Overall Survival (OS) in Arm A Versus Arm C in ITT-WT Population | Baseline until death (up approximately 53 months) | |
| Secondary | PFS, as Determined by the Independent Review Facility (IRF) in Arm B Versus Arm C in Teff-High-WT Population and ITT-WT Population | PFS, as determined by the independent review facility (IRF) Using RECIST v1.1 in Arm B versus Arm C in the T-effector (Teff)-high wild type (WT) population and the intent-to-treat (ITT)-WT population. | Baseline until disease progression or death, whichever occurs first (up to approximately 29 months) | |
| Secondary | PFS, as Determined by the Investigator in Arm B Versus Arm C in Teff High Population and ITT Population | PFS, as determined by the investigator according to RECIST v1.1, in Arm B versus C in the Teff high population and ITT population. | Baseline until disease progression or death, whichever occurs first (up to approximately 29 months) | |
| Secondary | PFS, as Determined by the Investigator in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population | PFS, as determined by the investigator according to RECIST v1.1, in Arm A versus B in the Teff high-WT population and ITT-WT population. | Baseline until disease progression or death, whichever occurs first (up to approximately 29 months) | |
| Secondary | PFS, as Determined by the Investigator in Arm B Versus Arm C by PD-L1 Subgroup | PFS as Determined by the Investigator according to RECIST v1.1, in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population) | Baseline until disease progression or death, whichever occurs first (up to approximately 29 months) | |
| Secondary | OS in Arm B Versus Arm C by PD-L1 Subgroup | OS in Arm B Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population) | Baseline until death (up to approximately 34 months) | |
| Secondary | OS in Arm A Versus Arm C by PD-L1 Subgroup | OS in Arm A Versus Arm C by PD-L1 Subgroup: TC2/3 or 1C2/3 and TC1/2/3 or IC1/2/3 (ITT-WT Population) | Baseline until death (up approximately 53 months) | |
| Secondary | OS in Arm B Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population | Baseline until death (up to approximately 34 months) | ||
| Secondary | OS in Arm A Versus Arm C in Teff High-WT Population, Teff High Population, and ITT Population | Baseline until death (up approximately 53 months) | ||
| Secondary | OS in Arm A Versus Arm B in Teff High-WT Population and ITT-WT Population | Baseline until death (up approximately 53 months) | ||
| Secondary | Duration of Response (DOR), as Determined By Investigator in Arm B Versus Arm C | DOR, as determined by investigator according to RECIST v1.1 in Arm B versus Arm C in the Teff high-WT population and the ITT-WT population. | Baseline until disease progression or death, whichever occurs first (up to approximately 29 months) | |
| Secondary | Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator in the Teff-High-WT Population and ITT-WT Population | Percentage of Participants With an Objective Response (OR) (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator using RECIST v1.1 in the Teff-High-WT population and ITT-WT population. | Baseline until disease progression or death, whichever occurs first (up to approximately 29 months) | |
| Secondary | OS Rates at Years 1 and 2 in Arm B Versus Arm C | OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population. | Baseline to 2 years or death, whichever occurs first. | |
| Secondary | OS Rates at Years 1 and 2 in Arm A Versus Arm C | OS at 1- and 2-year landmark timepoints in Teff-high WT population and ITT-WT population. | Baseline to 2 years or death, whichever occurs first. | |
| Secondary | Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms Determined by European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire-Core 30 (QLQ-C30) Score | EORTC QLQ-C30 is a validated & reliable self-report measure (Aaronson et al.1993;Fitzsimmons et al.1999) that consists of 30 questions that assess 5 aspects of patient functioning (physical,emotional,role, cognitive,and social), 3 symptom scales (fatigue,nausea & vomiting, pain),global health/quality of life,and six single items (dyspnea,insomnia, appetite loss,constipation,diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life);however a high score for a symptom scale or item represents a high level of symptomatology or problems. A =10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al.1998). | Baseline up to approximately 29 months | |
| Secondary | TTD in Patient-Reported Lung Cancer Symptoms as Determined by EORTC Quality-of-Life Questionnaire-Core Lung Cancer Module 13 (QLQ-LC13) Score | QLQ-LC13 Quality-of-Life Questionnaire Lung Cancer Module incorporates one multiple-item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A =10-point change in the symptoms subscale score is perceived by patients as clinically significant (Osoba et al. 1998). | Baseline up to approximately 29 months | |
| Secondary | Change From Baseline in Patient-Reported Lung Cancer Symptoms Score Using the Symptoms in Lung Cancer (SILC) Scale | The SILC (Symptoms in Lung Cancer) scale was used to assess patient-reported severity of lung cancer symptoms (chest pain, dyspnea, and cough). The SILC scale is a 9-item content validated self-report measure of lung cancer symptoms. It measures severity of cough, dyspnea, and chest pain with a symptom severity score. The SILC questionnaire comprises three individual symptoms (dyspnea, cough, chest pain) and are scored at the individual symptom level, thus have a dyspnea score, chest pain score, and cough score. Each individual symptom score is calculated as the average of responses for the symptom items [e.g. Chest Pain Score=mean (item 1; item 2)]. An increase in score is suggestive of a worsening in symptomology (i.e. frequency or severity). A score change of =0.3 points for the dyspnea and cough symptom scores is considered to be clinically significant; whereas a score change of =0.5 points for the chest pain score is considered to be clinically significant. | Baseline up to approximately 29 months | |
| Secondary | Percentage of Participants With Adverse Events | Percentage of participants with at least one adverse event. | Baseline up to data cutoff date 7 December 2020 (up to approximately 68 months) | |
| Secondary | Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab | Baseline up to approximately 29 months | ||
| Secondary | Maximum Observed Serum Concentration (Cmax) of Atezolizumab in Arm A and Arm B | The predose samples will be collected on the same day of treatment administration. The infusion duration of atezolizumab will be of 30-60 minutes. | Day 1 of Cycle 1 and 3 (Cycle length=21 days) | |
| Secondary | Minimum Observed Serum Concentration (Cmin) of Atezolizumab Prior to Infusion in Arm A and Arm B | Day 21 of Cycles 1, 2 3, and 7 (Cycle length=21 days) | ||
| Secondary | Plasma Concentrations for Carboplatin in Arm A, Arm B, and Arm C | Predose (same day of treatment administration), 5-10 minutes before end of carboplatin infusion, 1 h after carboplatin infusion (infusion duration=15 to 30 minutes) on D1 of Cy1,3 (Cycle length=21 days) | ||
| Secondary | Plasma Concentrations for Paclitaxel in Arm A, Arm B, and Arm C | Predose (same day of treatment administration), 5-10 minutes before end of paclitaxel infusion, 1 h after paclitaxel infusion (infusion duration=3 h) on D1 of Cy1,3 (Cycle length=21 days) | ||
| Secondary | Cmax of Bevacizumab in Arm B and Arm C | Cycle 1 Day 1 and Cycle 3 Day 1 (Cycle length=21 days) | ||
| Secondary | Cmin of Bevacizumab in Arm B and Arm C | Cycle 1 Day 1 and Cycle 2 Day 21 (Cycle length=21 days) |
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