A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)

Triple Negative Breast Cancer Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Placebo-Controlled Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425891
• Other study ID #: WO29522
• Secondary ID: 2014-005490-37
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2015
• Est. completion date: August 31, 2021

Study information

• Verified date: June 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 902
• Est. completion date: August 31, 2021
• Est. primary completion date: April 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
• No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
• Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
• A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Measurable disease as defined by RECIST v1.1
• Adequate hematologic and end-organ function

Exclusion Criteria:

• Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
• Leptomeningeal disease
• Pregnancy or lactation
• History of autoimmune disease
• Prior allogeneic stem cell or solid organ transplantation
• Positive test for human immunodeficiency virus
• Active hepatitis B or hepatitis C
• Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
Atezolizumab at a fixed dose of 840 milligrams via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
• Nab-Paclitaxel
Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle. Nab-Paclitaxel was administered for a target of at least 6 cycles, with no maximum in the absence of disease progression or unacceptable toxicity.
• Placebo
Placebo administered via IV infusion on Days 1 and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Locations

Country	Name	City	State
Argentina	Centro de Oncologia e Investigacion Buenos Aires (COIBA)	Buenos Aires
Argentina	Fundación CENIT para la Investigación en Neurociencias	Buenos Aires
Argentina	Centro Oncologico Riojano Integral (CORI)	La Rioja
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	Peninsula and South Eastern Haematology and Oncology Group	Frankston	Victoria
Australia	Peter MacCallum Cancer Centre; Medical Oncology	Melbourne	Victoria
Australia	Icon Cancer Foundation	South Brisbane	Queensland
Australia	Sunshine Hospital	St Albans	Victoria
Australia	St John of God Hospital; Bendat Cancer Centre	Subiaco	Western Australia
Australia	Nepean Cancer Care Centre	Sydney	New South Wales
Australia	Princess Alexandra Hospital; Division of Cancer Services	Woolloongabba	Queensland
Austria	Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I	Graz
Austria	Ordensklinikum Linz Barmherzige Schwestern; Abt. fur Innere Medizin 1	Linz
Austria	A.Ö. Lhk; Ii. Medizinische Abt. Mit Schwerpunkt Gaströnter. & Onkologie	Steyr
Austria	Medizinische Universität Wien; Univ.Klinik für Innere Medizin I	Wien
Belgium	Institut Jules Bordet	Anderlecht
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	GHdC Site Notre Dame	Charleroi
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven Gasthuisberg	Leuven
Belgium	Sint Augustinus Wilrijk	Wilrijk
Bosnia and Herzegovina	Clinic of Oncology, University Clinical Center Sarajevo	Sarajevo
Brazil	Centro de Pesquisas Oncologicas - CEPON	Florianopolis	SC
Brazil	Crio - Centro Regional Integrado de Oncologia	Fortaleza	CE
Brazil	Hospital Araujo Jorge; Departamento de Ginecologia E Mama	Goiania	GO
Brazil	Hospital de Caridade de Ijui; Oncologia	Ijui	RS
Brazil	Clinica de Neoplasias Litoral	Itajai	SC
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Hospital Sao Lucas - PUCRS	Porto Alegre	RS
Brazil	Santa Casa de Misericordia de Salvador	Salvador	BA
Brazil	Hospital Perola Byington	Sao Paulo	SP
Brazil	Hospital Sao Jose	Sao Paulo	SP
Canada	Tom Baker Cancer Centre-Calgary	Calgary	Alberta
Canada	Cross Cancer Institute ; Dept of Medical Oncology	Edmonton	Alberta
Canada	Queen Elizabeth II Health Sciences Centre; Oncology	Halifax	Nova Scotia
Canada	BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)	Kelowna	British Columbia
Canada	Kingston General Hospital	Kingston	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	Lakeridge Health Oshawa; Oncology	Oshawa	Ontario
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	Hopital du Saint Sacrement	Quebec City	Quebec
Canada	Sunnybrook Odette Cancer Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre	Vancouver	British Columbia
Chile	Centro de Cancer Pontificie Universidad Catolica de Chile	Santiago
Chile	Sociedad de Investigaciones Medicas Ltda (SIM)	Temuco
Colombia	Clinica del Country	Bogota
Colombia	Oncomedica S.A.	Monteria
Costa Rica	Clinica CIMCA	San José
Costa Rica	ICIMED Instituto de Investigación en Ciencias Médicas	San José
Czechia	Fakultni nemocnice Olomouc; Onkologicka klinika	Olomouc
Czechia	Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika	Praha 2
Czechia	Fakultni nemocnice v Motole	Praha 5
Estonia	North Estonia Medical Centre Foundation; Oncology Centre	Tallinn
Estonia	Tartu Uni Hospital; Hematology - Oncology Clinic	Tartu
Finland	Tampere University Hospital; Dept of Oncology	Tampere
France	Ico - Paul Papin	Angers
France	Institut Sainte Catherine	Avignon
France	Hopital Jean Minjoz	Besancon
France	HOPITAL MICHALLON - CENTRE HOSPITALIER UNIVERSITAIRE DE GRENOBLE, Service d'oncologie Médicale	Grenoble
France	Centre Oscar Lambret	Lille
France	Centre Leon Berard	Lyon
France	Institut régional du Cancer Montpellier	Montpellier
France	Clinique Catherine de Sienne	Nantes
France	Hopital La Pitie Salpetriere	Paris
France	Institut Curie	Paris
France	Institut De Cancerologie De L'Ouest; Medical Oncology	Saint Herblain
France	Centre Paul Strauss	Strasbourg
Germany	Ambulantes Tumorzentrum Spandau; Dres. Benno Mohr und Uwe Peters	Berlin
Germany	St. Johannes Hospital; Abt. für Hämatologie und Onkologie	Dortmund
Germany	Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden	Dresden
Germany	Universitätsklinikum Erlangen; Frauenklinik	Erlangen
Germany	Uniklinik Essen; Gynäkologie	Essen
Germany	Niels-Stensen-Kliniken Franziskus-Hospital Harderberg GmbH	Georgsmarienhütte
Germany	Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie	Halle
Germany	Facharztzentrum Eppendorf, Studien GbR	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf; Frauenklinik	Hamburg
Germany	Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen	Heidelberg
Germany	Praxis Köppler, Heymann, Weide, Thomalla; Fä Für Innere Medizin	Koblenz
Germany	St. Elisabeth-Krankenhaus; Brustzentrum	Köln
Germany	Universitätsklinikum Schleswig-Holstein; Campus Lübeck	Lübeck
Germany	Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde	München
Germany	Gemeinschaftspraxis für Hämatologie und Onkologie	Münster
Germany	MVZ Nordhausen gGmbH, Praxis Dr. Grafe	Nordhausen
Germany	Oncologianova GmbH - Gesellschaft für Innovationen in der Onkologie	Recklinghausen
Germany	Mutterhaus der Borromäerinnen gGmbH, Abteilung Hämatologie-Onkologie	Trier
Germany	Dres. Helmut Forstbauer, Carsten Ziske und Kollegen; Onkologische Schwerpunktpraxis	Troisdorf
Germany	Universitätsklinik Tübingen; Frauenklinik & Poliklinik	Tübingen
Greece	Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine	Athens
Greece	IASO General Hospital of Athens	Athens
Greece	Univ General Hosp Heraklion; Medical Oncology	Heraklion
Greece	University Hospital of Patras Medical Oncology	Patras
Greece	Euromedical General Clinic of Thessaloniki; Oncology Department	Thessaloniki
Guatemala	Grupo Angeles	Guatemala City
Hong Kong	Queen Mary Hospital; Dept of Medicine	Hong Kong
Hungary	Fövárosi Önkormányzat uzsoki utcai Kórház	Budapest
Hungary	Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly	Budapest
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged
Italy	Irccs Istituto Europeo Di Oncologia (IEO); Ricerca Di Senologia Medica	Milano	Lombardia
Italy	Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica	Napoli	Campania
Japan	Aichi Cancer Center Hospital	Aichi
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Gunma Prefectural Cancer Center	Gunma
Japan	Hiroshima City Hiroshima Citizens Hospital	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	National Hospital Organization Hokkaido Cancer Center	Hokkaido
Japan	Hyogo Medical University Hospital	Hyogo
Japan	Sagara Hospital	Kagoshima
Japan	St. Marianna University Hospital	Kanagawa
Japan	Tokai University Hospital	Kanagawa
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kyoto University Hospital	Kyoto
Japan	Mie University Hospital	Mie
Japan	Tohoku University Hospital	Miyagi
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Okayama University Hospital	Okayama
Japan	Naha-nishi Clinic	Okinawa
Japan	Kindai University Hospital	Osaka
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka
Japan	Saitama Cancer Center	Saitama
Japan	Saitama Medical University International Medical Center	Saitama
Japan	Shizuoka Cancer Center	Shizuoka
Japan	Komagome Hospital	Tokyo
Japan	National Cancer Center Hospital	Tokyo
Japan	St. Luke's International Hospital	Tokyo
Japan	The Cancer Institute Hospital of JFCR	Tokyo
Korea, Republic of	National Cancer Center	Goyang-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Latvia	Daugavpils Regional Hospital	Daugavpils
Latvia	Riga East Clinical University Hospital Latvian Oncology Centre	Riga
Mexico	Centro Medico Dalinde	Cdmx	Mexico CITY (federal District)
Mexico	Instituto Estatal de Cancerologia Colima	Colima
Mexico	Iem-Fucam	D.f.
Mexico	Consultorio de Medicina Especializada; Dentro de Condominio San Francisco	Mexico City
Mexico	Centro Médico Zambrano Hellion	Monterrey	Nuevo LEON
Norway	Helse Bergen HF Haukeland universitetssjukehus kreftavdelingen poliklinikk	Bergen
Norway	Sørlandet Sykehus Kristiansand	Kristiansand
Norway	Stavanger Universitetssykehus, Helse Stavanger HF	Stavanger
Panama	Centro Oncológico de Panamá	Panama
Poland	Centrum Onkologii w Bydgoszczy; Oddzial Kliniczny Onkologii	Bydgoszcz
Poland	Szpitale Wojewodzkie w Gdyni Sp. z o.o.	Gdynia
Poland	Szpital Uniwersytecki w Krakowie, Oddzial Kliniczny Kliniki Onkologii	Kraków
Poland	Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii	Lublin
Poland	Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr	Warszawa
Poland	Wojskowy Instytut Medyczny	Warszawa
Romania	Oncomed SRL	Timisoara
Russian Federation	Arkhangelsk Regional Clinical Oncology Dispensary	Arkhangelsk	Arhangelsk
Russian Federation	Ivanovo Regional Oncology Dispensary	Ivanovo
Russian Federation	Clinical Oncology Dispensary of Ministry of Health of Tatarstan	Kazan
Russian Federation	Moscow City Oncology Hospital #62	Moscovskaya Oblast	Moskovskaja Oblast
Russian Federation	Main Military Clinical Hospital named after N.N. Burdenko	Moscow	Moskovskaja Oblast
Russian Federation	Blokhin Cancer Research Center; Combined Treatment	Moskva	Moskovskaja Oblast
Russian Federation	S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)	Saint-Petersburg
Singapore	National Cancer Centre	Singapore
Singapore	National University Hospital	Singapore
Slovenia	Institute of Oncology Ljubljana	Ljubljana
Spain	Hospital del Mar; Servicio de Oncologia	Barcelona
Spain	Hospital Duran i Reynals; Oncologia	Barcelona
Spain	Hospital Univ Vall d'Hebron; Servicio de Oncologia	Barcelona
Spain	Hospital Universitario Reina Sofia; Servicio de Oncologia	Córdoba	Cordoba
Spain	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Madrid
Spain	Hospital Universitario La Paz; Servicio de Oncologia	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Malaga
Spain	Instituto Valenciano Oncologia; Oncologia Medica	Valencia
Sweden	Sodersjukhuset; Onkologkliniken	Stockholm
Sweden	Akademiska sjukhuset, Onkologkliniken	Uppsala
Switzerland	Universitaetsspital Basel; Onkologie	Basel
Switzerland	Kantonsspital St.Gallen Brustzentrum/Chirurgie; Brustzentrum	St. Gallen
Switzerland	Universitätsspital Zürich	Zürich
Taiwan	Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery	Kaohsiung
Taiwan	China Medical University Hospital; Surgery	Taichung
Taiwan	National Taiwan Uni Hospital; General Surgery	Taipei
Taiwan	VETERANS GENERAL HOSPITAL; Department of General Surgery	Taipei
Thailand	Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology	Bangkok
Thailand	Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc	Bangkok
Thailand	Songklanagarind Hospital; Department of Oncology	Songkhla
Turkey	Cukurova Uni Faculty of Medicine; Medical Oncology	Adana
Turkey	Istanbul University Cerrahpasa Medical Faculty; Radiation Oncology Department	Istanbul
Turkey	Medipol University MF; Oncology Department	Istanbul
Turkey	Ege Uni Medical Faculty Hospital; Oncology Dept	Izmir
Turkey	Hacettepe Uni Medical Faculty Hospital; Oncology Dept	Sihhiye/Ankara
Ukraine	Chemotherapy SI Dnipropetrovsk MA of MOHU	Dnipropetrovsk
Ukraine	Kyiv City Clinical Oncological Center	Kyiv
Ukraine	Treatment and Prevention Institution Volyn Regional Oncology Dispensary	Lutsk
Ukraine	Lviv State Oncology Regional Treatment and Diagnostic Centre	Lviv
United Kingdom	Velindre Cancer Centre	Cardiff
United Kingdom	Western General Hospital; Clinical Oncology	Edinburgh
United Kingdom	Guys ST Thomas Hospital	London
United Kingdom	Royal Marsden Hospital - London	London
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	Christie Hospital Nhs Trust; Medical Oncology	Manchester
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Royal Preston Hosptial	Preston
United Kingdom	Weston Park Hospital	Sheffield
United Kingdom	Royal Marsden Hospital; Dept of Medical Oncology	Sutton
United States	Kaiser Permanente Of Colorado	Aurora	Colorado
United States	Johns Hopkins Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Mercy Medical Center	Baltimore	Maryland
United States	St. Luke's Cancer Care Associates	Bethlehem	Pennsylvania
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Wellmont Bristol Regional Medical Center	Bristol	Tennessee
United States	Montefiore Medical Center	Bronx	New York
United States	Rush University Medical Center - Chicago	Chicago	Illinois
United States	Onc/Hem Care Clin Trials LLC	Cincinnati	Ohio
United States	The Mark H. Zangmeister Ctr; Mid Ohio Onc/Hem Inc.	Columbus	Ohio
United States	Barbara Ann Karmanos Cancer Institute; Oncology	Detroit	Michigan
United States	Texas Oncology- El Paso Cancer Treatment Center Gateway	El Paso	Texas
United States	Inova Medical Group	Fairfax	Virginia
United States	Florida Cancer Specialists - SCRI; Pharmacy	Fort Myers	Florida
United States	West Clinic	Germantown	Tennessee
United States	Greenville Health System (GHS) Cancer Institute	Greenville	South Carolina
United States	The Methodist Cancer Center	Houston	Texas
United States	University of Texas;M.D. Anderson Cancer Center	Houston	Texas
United States	Jackson Oncology Associates, PLLC	Jackson	Mississippi
United States	Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)	Jacksonville	Florida
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC	Kansas City	Missouri
United States	ProHEALTH Care Associates LLP	Lake Success	New York
United States	New Hampshire Hematology Oncology	Manchester	New Hampshire
United States	Northwest Georgia Oncology Centers PC - Marietta	Marietta	Georgia
United States	The Mount Siani Comprehensive Cancer Center	Miami Beach	Florida
United States	Sarah Cannon Cancer Center - Tennessee Oncology, Pllc	Nashville	Tennessee
United States	Vanderbilt	Nashville	Tennessee
United States	Yale Cancer Center; Medical Oncology	New Haven	Connecticut
United States	Laura and ISAAC Perlmutter Cancer Center at NYU Langone.	New York	New York
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Kaiser Permanente of Northern California	Oakland	California
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania
United States	Florida Cancer Research Institute	Plantation	Florida
United States	Kaiser Perm NW - Rheuma	Portland	Oregon
United States	Providence Cancer Center	Portland	Oregon
United States	Emad Ibrahim, Md, Inc	Redlands	California
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Maryland Oncology Hematology	Rochville	Maryland
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building)	Saint Petersburg	Florida
United States	Univ of Calif, San Francisco; Breast Cancer Center	San Francisco	California
United States	Kaiser Permanente - San Marcos	San Marcos	California
United States	Cancer Research Collaboration, Inc.	Santa Ana	California
United States	Cancer Care Northwest	Spokane	Washington
United States	Highlands Oncology Group	Springdale	Arkansas
United States	Stamford Hospital; BCC, MOHR	Stamford	Connecticut
United States	Stanford Univ School of Med; Oncology	Stanford	California
United States	MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bosnia and Herzegovina,  Brazil,  Canada,  Chile,  Colombia,  Costa Rica,  Czechia,  Estonia,  Finland,  France,  Germany,  Greece,  Guatemala,  Hong Kong,  Hungary,  Italy,  Japan,  Korea, Republic of,  Latvia,  Mexico,  Norway,  Panama,  Poland,  Romania,  Russian Federation,  Singapore,  Slovenia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in All Randomized Participants	PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.	Baseline up to approximately 34 months
Primary	PFS According to RECIST v1.1 in Participants With Detectable Programmed Death-Ligand 1 (PD-L1)	PFS was defined as the time from randomization to the occurrence of disease progression, as determined by investigators from tumor assessments per RECIST v1.1, or death from any cause, whichever occurred first.	Baseline up to approximately 34 months
Primary	Overall Survival (OS) in All Randomized Participants	OS was defined as the time from the date of randomization to the date of death from any cause.	Baseline until death due to any cause (up to approximately 58 months)
Primary	OS in Participants With Detectable PD-L1	OS was defined as the time from the date of randomization to the date of death from any cause.	Baseline until death due to any cause (up to approximately 58 months)
Secondary	Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 in All Randomized Participants	An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.	Baseline up to approximately 34 months
Secondary	Percentage of Participants With an Objective Response of CR or PR According to RECIST v1.1 in Participants With Detectable PD-L1	An objective response was defined for participants with measurable disease at baseline as either a partial response (PR) or a complete response (CR) using RECIST v1.1.	Baseline up to approximately 34 months
Secondary	Duration of Response (DOR) According to RECIST v1.1 in All Randomized Participants	DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.	Baseline up to approximately 34 months
Secondary	DOR Acccording to RECIST v1.1 in Participants With Detectable PD-L1	DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first.	Baseline up to approximately 34 months
Secondary	Time to Deterioration (TTD) in Global Health Status/Health Related Quality of Life According to European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire Core 30 (QLQ-C30) v3.0 in All Randomized Participants	Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participant's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.	Baseline up to approximately 58 months
Secondary	TTD in Global Health Status/Health Related Quality of Life According to EORTC QLQ-C30 v3.0 in Participants With Detectable PD-L1	Deterioration in GHS/HRQoL (Items 29, 30 of the EORTC QLQ C30) was defined by the following two criteria: 1. The time from randomization to the first time the participants's GHS/HRQoL scale score showed a >=10-point decrease from the baseline scale score. A 10-point change was defined as the minimally important difference (MID). 2. The score decrease of >= 10-points from baseline was held for at least two consecutive cycles, or an initial score decrease of >= 10-points was followed by death or treatment discontinuation within 3 weeks from the last assessment.	Baseline up to approximately 58 months
Secondary	Percentage of Participants With at Least One Adverse Event	Percentage of participants with at least one adverse event.	Baseline up to to the data cutoff date: 31 August 2021 (up to approximately 74 months)
Secondary	Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab	Percentage of Participants with Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab	Baseline up to approximately 53 months
Secondary	Maximum Serum Concentration (Cmax) for Atezolizumab	Maximum serum concentration for atezolizumab.	Cycle 1 Day 1 (Cycle = 28 days)
Secondary	Minimum Serum Concentration (Cmin) for Atezolizumab	Minimum serum concentration for atezolizumab.	Day 27 of Cycle 1, 2, 3, and 7 (Cycle = 28 days)
Secondary	Plasma Concentrations of Total Paclitaxel	Plasma Concentrations of Total Paclitaxel	Pre-dose (Hour 0) on Cycle 1 Day 1, pre-dose (Hour 0), 5-10 minutes before end of nab-paclitaxel infusion, 1 hour after end of nab-paclitaxel infusion (infusion duration = 30 minutes) on Cycle 3 Day 1 (Cycle = 28 days)