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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02366143
Other study ID # GO29436
Secondary ID 2014-003207-30
Status Completed
Phase Phase 3
First received
Last updated
Start date March 31, 2015
Est. completion date December 7, 2020

Study information

Verified date August 2021
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
Bevacizumab
Bevacizumab was administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.
Carboplatin
Carboplatin was administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
Paclitaxel
Paclitaxel was administered as IV infusion at a dose of 200 milligrams per square meter (mg/m^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

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, 

Outcome

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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Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A