Clinical trial NCT02008227: A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy
Official title: A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Failure With Platinum Containing Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 1225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


Eligibility criteria: Inclusion Criteria:

* Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
* Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Known active or untreated central nervous system (CNS) metastases
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Active hepatitis B or hepatitis C
* Prior treatment with docetaxel
* Prior treatment with cluster of differentiation 137 (CD137) agonists, anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents

Primary outcomes:
measure: Percentage of Participants Who Died: PP-ITT
timeFrame: Baseline until death due to any cause (up to approximately 2.25 years)
measure: Percentage of Participants Who Died: Tumor Cells (TC)1/2/3 or Tumor-Infiltrating Immune Cells (IC)1/2/3 Subgroup of PP
timeFrame: Baseline until death due to any cause (up to approximately 2.25 years)
measure: Overall Survival (OS): PP-ITT
timeFrame: Baseline until death due to any cause (up to approximately 2.25 years)
measure: OS: TC1/2/3 or IC1/2/3 Subgroup of PP
timeFrame: Baseline until death due to any cause (up to approximately 2.25 years)
measure: OS: SP-ITT
timeFrame: Baseline until death due to any cause (up to approximately 2.87 years)
measure: OS: TC1/2/3 Or IC1/2/3 Subgroup of SP
timeFrame: Baseline until death from any cause (approximately 2.87 years)
measure: OS: TC2/3 or IC2/3 Subgroup of SP
timeFrame: Baseline until death due to any cause (up to approximately 2.87 years)
measure: OS: TC3 or IC3 Subgroup of SP
timeFrame: Baseline until death due to any cause (up to approximately 2.87 years)
Secondary outcomes:
measure: Percentage of Participants With Disease Progression (PD) as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) or Death: PP-ITT
timeFrame: Baseline up to PD or Death (up to approximately 2.25 years)
measure: Percentage of Participants With PD as Determined by Investigator Using RECIST v1.1 or Death: TC1/2/3 or IC1/2/3 Subgroup of PP
timeFrame: Baseline up to PD or Death (up to approximately 2.25 years)
measure: Progression-Free Survival (PFS) as Determined by Investigator Using RECIST v1.1: PP-ITT
timeFrame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
measure: PFS as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
timeFrame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
measure: Percentage of Participants With Objective Response as Determined Using RECIST v1.1: PP-ITT
timeFrame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
measure: Percentage of Participants With Objective Response as Determined Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
timeFrame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
measure: Duration of Response (DOR) as Determined by Investigator Using RECIST v1.1: PP-ITT
timeFrame: From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
measure: DOR as Determined by Investigator Using RECIST v1.1: TC1/2/3 or IC1/2/3 Subgroup of PP
timeFrame: From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.25 years)
measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) Against Atezolizumab
timeFrame: Baseline up to approximately 2.25 years (assessed at predose [Hour {Hr} 0] on Day 1 of Cycles 1, 2, 3, 4, 8, 16, then every 8 cycles up to end of treatment (EOT) [approximately 2.25 years]; 120 days after EOT [approximately 2.25 years] [1 Cycle=21 days])
measure: Maximum Observed Serum Atezolizumab Concentration (Cmax)
timeFrame: Predose (Hr 0), 30 minutes (min) post-infusion (infusion duration: 60 min) on Cycle 1 Day 1 (1 Cycle=21 days)
measure: Minimum Observed Serum Atezolizumab Concentration (Cmin)
timeFrame: Predose (Hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8, 16, 24, 32, EOT (approximately 2.25 years); 120 days after EOT (approximately 2.25 years) (1 Cycle=21 days)
measure: Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms, Using the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire (QLQ) Lung Cancer Supplemental Module 13 (LC13)
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years) (1 Cycle = 21 days)
measure: EORTC QLQ Core 30 (C30) Questionnaire Score: Single Items
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-C30 Questionnaire Score: Functional Subscales
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-C30 Questionnaire Score: GHS Scale
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-C30 Questionnaire Score: Symptom Subscale
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Alopecia
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Coughing
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Dysphagia
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Dyspnea
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Hemoptysis
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD ( Pro Week 6 Pd) (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Pain in Arm or Shoulder
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Pain in Chest
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Peripheral Neuropathy
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Pain in Other Parts
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: EORTC QLQ-LC13 Questionnaire Score: Sore Mouth
timeFrame: Day 1 of each treatment Cycle up to EOT (up to approximately 2.25 years); 6 week following PD (up to approximately 2.25 years); survival follow-up-1 (up to approximately 2.25 years) (1 Cycle= 21 days)
measure: PFS as Determined by Investigator Using RECIST v1.1: SP-ITT
timeFrame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
measure: Percentage of Participants With Objective Response as Determined Using RECIST v1.1: SP-ITT
timeFrame: Baseline up to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
measure: DOR as Determined by Investigator Using RECIST v1.1: SP ITT
timeFrame: From first objective response of CR or PR to PD or death due to any cause, whichever occurred first (up to approximately 2.87 years)
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Blood/Cancer Ctr
state: California
city: Burbank
country: United States
facility: Roy & Patricia Disney Family Cancer Center
state: California
city: Fullerton
country: United States
facility: St. Jude Heritage Healthcare; Virgiia K.Crosson Can Ctr
state: California
city: Hayward
country: United States
facility: Kaiser Permanente - Hayward
state: California
city: La Jolla
country: United States
facility: Scripps Clinic; Hematology & Oncology
state: California
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Los Angeles
country: United States
facility: Univ of Calif, Los Angeles; Hematology/Oncology
state: California
city: Northridge
country: United States
facility: North Valley Hem Onc Med Grp; Thomas&Dorothy Leavey Can Ctr
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Redondo Beach
country: United States
facility: TMPN/ Cancer Care Associates
state: California
city: Roseville
country: United States
facility: Kaiser Permanente - Roseville
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: Sacramento
country: United States
facility: UC Davis; Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco (2238 Geary)
state: California
city: San Jose
country: United States
facility: K. Permanente - San Jose
state: California
city: San Luis Obispo
country: United States
facility: Coastal Integrative Cancer Care
state: California
city: San Marcos
country: United States
facility: Kaiser Permanente - San Marcos
state: California
city: Santa Clara
country: United States
facility: K. Permanente - Santa Clara
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology
state: California
city: South San Francisco
country: United States
facility: K. Permanente - S. San Fran
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente - Vallejo
state: California
city: Walnut Creek
country: United States
facility: K. Permanente - Walnut Creek
state: California
city: Grand Junction
country: United States
facility: St. Mary's Hospital Regional Cancer Center
state: Colorado
city: Lone Tree
country: United States
facility: Kaiser Permanente - Franklin; Kaiser Permanente - Lone Tree
state: Colorado
city: Jacksonville
country: United States
facility: Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
state: Florida
city: Miami
country: United States
facility: AMPM Research Clinic
state: Florida
city: Orlando
country: United States
facility: Orlando Health Inc.
state: Florida
city: Atlanta
country: United States
facility: Georgia Cancer Specialists
state: Georgia
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Bettendorf
country: United States
facility: Hematology-Oncology; Associates of the Quad Cities
state: Iowa
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Detroit
country: United States
facility: Karmanos Cancer Inst. ; Hudson Webber; Cancer Research Building
state: Michigan
city: Minneapolis
country: United States
facility: US Oncology Research at Minnesota Oncology
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Billings
country: United States
facility: Billings Clinic; Research Center
state: Montana
city: Missoula
country: United States
facility: Montana Cancer Specialists
state: Montana
city: Omaha
country: United States
facility: Oncology Hematology West Midwest
state: Nebraska
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue
state: Nevada
city: Florham Park
country: United States
facility: Summit Medical Center
state: New Jersey
city: Paramus
country: United States
facility: Luckow Pavillion, Valley Hosp; Office of Clinical Trials
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Inst.
state: New York
city: Clifton Park
country: United States
facility: New York Oncology Hematology PC - Latham
state: New York
city: Columbus
country: United States
facility: Mid Ohio Onc Hematology Inc
state: Ohio
city: Tulsa
country: United States
facility: Cancer Treatment Centers of America-Tulsa
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Ctr - 520 Country Club
state: Oregon
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Austin
country: United States
facility: Texas Onc-Central Austin CA Ct
state: Texas
city: Houston
country: United States
facility: The Methodist Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology, P.A. - Tyler; Tyler Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Roanoke
country: United States
facility: Blue Ridge Cancer Care
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists - Vancouver
state: Washington
city: Milwaukee
country: United States
facility: Aurora Health Care; Patient Centered Research
state: Wisconsin
city: Córdoba
country: Argentina
facility: Instituto Medico Rio Cuarto
city: Provincia De Buenos Aires
country: Argentina
facility: COIBA
city: Rosario
country: Argentina
facility: Instituto de Oncología de Rosario
city: Innsbruck
country: Austria
facility: Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
city: Vöcklabruck
country: Austria
facility: Lkh Vöcklabruck; I. Abt. Für Innere Medizin
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Laval
country: Canada
facility: Cite de La Sante de Laval; Hemato-Oncologie
state: Quebec
city: Montreal
country: Canada
facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
state: Quebec
city: Recoleta
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
city: Temuco
country: Chile
facility: Sociedad de Investigaciones Medicas Ltda (SIM)
city: Vina Del Mar
country: Chile
facility: ONCOCENTRO APYS; Oncología
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital; Dep. of Pulmonary Medicine
city: Oulu
country: Finland
facility: Oulu University Hospital; Oncology
city: Tampere
country: Finland
facility: Tampere University Hospital; Dept of Oncology
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Besancon
country: France
facility: Hopital Jean Minjoz; Pneumologie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
city: Caen
country: France
facility: Centre Francois Baclesse
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal; Service de Pneumologie
city: Grenoble
country: France
facility: Chu Grenoble - Hopital Albert Michallon; Departement de Cancero-Hematologie
city: Le Mans
country: France
facility: Centre Jean Bernard; Radiotherapie Chimiotherapie
city: Lille
country: France
facility: Centre Oscar Lambret
city: Marseille
country: France
facility: Hopital Nord; Service d'Oncologie Multidisciplinaire et Innovation Thérapeutique
city: Mulhouse
country: France
facility: Hopital Emile Muller;Pneumologie
city: Paris
country: France
facility: Hopital Cochin; Unite Fonctionnelle D Oncologie
city: Paris
country: France
facility: Hopital Saint Louis; Oncologie Medicale
city: Paris
country: France
facility: GH Paris Saint Joseph; Pneumologie
city: Paris
country: France
facility: Hopital Tenon;Pneumologie
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud; Pneumologie
city: Pringy
country: France
facility: CH de la region d Annecy
city: Rennes
country: France
facility: Hopital de Pontchaillou; Service de Pneumologie
city: Strasbourg
country: France
facility: Centre Paul Strauss; Oncologie Medicale
city: Suresnes
country: France
facility: Hopital Foch; Pneumologie
city: Toulon
country: France
facility: Hia Sainte Anne; Pneumologie
city: Toulouse
country: France
facility: Hopital Larrey; Pneumologie
city: Berlin
country: Germany
facility: Helios Klinikum Emil von Behring GmbH
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
city: Gauting
country: Germany
facility: Asklepios-Fachkliniken Muenchen-Gauting; Onkologie
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Hemer
country: Germany
facility: Lungenklinik Hemer
city: Immenhausen
country: Germany
facility: Fachklinik für Lungenerkrankungen
city: Köln
country: Germany
facility: Krankenhaus Merheim Lungenklinik
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie
city: Athens
country: Greece
facility: Uoa Sotiria Hospital; Oncology
city: Patras
country: Greece
facility: University Hospital of Patras Medical Oncology
city: Thermi Thessalonikis
country: Greece
facility: Thermi Clinic; Oncology Clinic
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Budapest
country: Hungary
facility: Semmelweis Egyetem X; Pulmonologiai Klinika
city: Pecs
country: Hungary
facility: University of Pecs, I st Dept of Internal Medicine
city: Torokbalint
country: Hungary
facility: Tudogyogyintezet Torokbalint
city: Avellino
country: Italy
facility: Azienda Ospedaliera San Giuseppe Moscati
state: Campania
city: Napoli
country: Italy
facility: Seconda Universita' Degli Studi; Divsione Di Oncologia Medica
state: Campania
city: Parma
country: Italy
facility: Azienda Ospedaliera Univ Parma; Dept Oncologia Medica
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
state: Friuli-Venezia Giulia
city: Udine
country: Italy
facility: Azienda Ospedaliero-Uni Ria Di Udine; Dept. Di Oncologia - Padiglione Pennato
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Uni Cattolica Policlinico Gemelli; Oncologia Medica Ist. Medicina Interna
state: Lazio
city: Genova
country: Italy
facility: Istituto Nazionale per la Ricerca sul Cancro di Genova
state: Liguria
city: Milano
country: Italy
facility: Irccs Ospedale San Raffaele;Oncologia Medica
state: Lombardia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Oncologia Medica
state: Lombardia
city: Bari
country: Italy
facility: Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
state: Puglia
city: Catania
country: Italy
facility: POLICLINICO RODOLICO, U.O. di Oncologia Medica
state: Sicilia
city: Lucca
country: Italy
facility: Ospedale San Luca; Oncologia
state: Toscana
city: Pisa
country: Italy
facility: A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
state: Toscana
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda
state: Veneto
city: Verona
country: Italy
facility: A.O.U. Integrata Verona - Policlinico G.B. Rossi; Oncologia Medica - Dip. di Medicina
state: Veneto
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital; Respiratory Medicine
city: Chiba
country: Japan
facility: National Cancer Center Hospital East; Thoracic Oncology
city: Ehime
country: Japan
facility: National Hospital Organization Shikoku Cancer Center; Internal Medicine
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center, Thoracic Oncology
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital; Respiratory Medicine
city: Hyogo
country: Japan
facility: Hyogo Cancer Center; Thoracic Oncology
city: Miyagi
country: Japan
facility: Miyagi Cancer Center; Respiratory Medicine
city: Okayama
country: Japan
facility: Okayama University Hospital; Respiratory and Allergy Medicine
city: Osaka
country: Japan
facility: Kindai University Hospital; Medical Oncology
city: Osaka
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center; Internal Medicine
city: Saitama
country: Japan
facility: Saitama Cancer Center; Thoracic Oncology
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center; Thoracic Oncology
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Thoracic Medical Oncology
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR, Respiratory Medicine
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital; Dept of Surgery
city: Yamaguchi
country: Japan
facility: National Hospital Organization, Yamaguchi - Ube Medical Center; Oncology Medicine
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center; Medical Oncology
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital; Hematology Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital; Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center; Gastroenterology
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital; Medical Oncology
city: 'S Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis; Dept of Lung Diseases
city: Nieuwegein
country: Netherlands
facility: Antonius Ziekenhuis; Dept of Lung Diseases
city: Auckland
country: New Zealand
facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital; Dept of Medical Oncology
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF; Radiumhospitalet
city: Panama
country: Panama
facility: Centro Hemato Oncologico Panama
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Lodz
country: Poland
facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii
city: Poznan
country: Poland
facility: Med.-Polonia Sp. z o.o. NSZOZ
city: Warszawa
country: Poland
facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii
city: Coimbra
country: Portugal
facility: Hospital Geral; Servico de Pneumologia
city: Lisboa
country: Portugal
facility: Hospital Pulido Valente; Servico de Pneumologia
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Moscow
country: Russian Federation
facility: N.N.Burdenko Main Military Clinical Hospital; Oncology Dept
city: Saint-Petersburg
country: Russian Federation
facility: City Clinical Onc.
city: Samara
country: Russian Federation
facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary
city: Belgrade
country: Serbia
facility: Clinic for Pulmonology, Clinical Center of Serbia
city: Sremska Kamenica
country: Serbia
facility: Institute for pulmonary diseases of Vojvodina
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
state: LAS Palmas
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro; Servicio de Oncologia
state: Madrid
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal; Servicio de Oncologia
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet; Servicio Oncologia
city: Goeteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Lungmedicinkliniken
city: Linköping
country: Sweden
facility: Universitetssjukhuset Linköping; Lungmedicinkliniken
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Solna; Lung Allergikliniken N10:02
city: Baden
country: Switzerland
facility: Kantonsspital Baden; Medizinische Klinik, Onkologie
city: Geneve
country: Switzerland
facility: HUG; Oncologie
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital; Medizinische Onkologie
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Internal Medicine
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital; Chest Dept , Section of Thoracic Oncology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital; Medical Oncology
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
city: Istanbul
country: Turkey
facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
city: Izmir
country: Turkey
facility: Izmir Suat Seren Chest Diseases and Surgery Research Hospital
city: Dnipropetrovsk
country: Ukraine
facility: State Medical Academy; Oncology
city: Kharkiv
country: Ukraine
facility: Karkiv Regional Oncology Center
city: Uzhgorod
country: Ukraine
facility: Uzhgorod Nat. University Central Municip Hosp; Onc Center
city: Grimsby
country: United Kingdom
facility: Diana Princess of Wales Hosp.
city: London
country: United Kingdom
facility: University College London Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital NHS Trust
city: Sutton in Ashfield
country: United Kingdom
facility: Kings Mill Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Cortellini A, Ricciuti B, Borghaei H, Naqash AR, D'Alessio A, Fulgenzi CAM, Addeo A, Banna GL, Pinato DJ. Differential prognostic effect of systemic inflammation in patients with non-small cell lung cancer treated with immunotherapy or chemotherapy: A post hoc analysis of the phase 3 OAK trial. Cancer. 2022 Aug 15;128(16):3067-3079. doi: 10.1002/cncr.34348. Epub 2022 Jun 21.
citation: Gadgeel S, Hirsch FR, Kerr K, Barlesi F, Park K, Rittmeyer A, Zou W, Bhatia N, Koeppen H, Paul SM, Shames D, Yi J, Matheny C, Ballinger M, McCleland M, Gandara DR. Comparison of SP142 and 22C3 Immunohistochemistry PD-L1 Assays for Clinical Efficacy of Atezolizumab in Non-Small Cell Lung Cancer: Results From the Randomized OAK Trial. Clin Lung Cancer. 2022 Jan;23(1):21-33. doi: 10.1016/j.cllc.2021.05.007. Epub 2021 May 30.
citation: Gandara D, Reck M, Moro-Sibilot D, Mazieres J, Gadgeel S, Morris S, Cardona A, Mendus D, Ballinger M, Rittmeyer A, Peters S. Fast progression in non-small cell lung cancer: results from the randomized phase III OAK study evaluating second-line atezolizumab versus docetaxel. J Immunother Cancer. 2021 Mar;9(3):e001882. doi: 10.1136/jitc-2020-001882.
citation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.
citation: Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.
citation: Morrissey KM, Marchand M, Patel H, Zhang R, Wu B, Phyllis Chan H, Mecke A, Girish S, Jin JY, Winter HR, Bruno R. Alternative dosing regimens for atezolizumab: an example of model-informed drug development in the postmarketing setting. Cancer Chemother Pharmacol. 2019 Dec;84(6):1257-1267. doi: 10.1007/s00280-019-03954-8. Epub 2019 Sep 21.
citation: Gadgeel SM, Lukas RV, Goldschmidt J, Conkling P, Park K, Cortinovis D, de Marinis F, Rittmeyer A, Patel JD, von Pawel J, O'Hear C, Lai C, Hu S, Ballinger M, Sandler A, Gandhi M, Fehrenbacher L. Atezolizumab in patients with advanced non-small cell lung cancer and history of asymptomatic, treated brain metastases: Exploratory analyses of the phase III OAK study. Lung Cancer. 2019 Feb;128:105-112. doi: 10.1016/j.lungcan.2018.12.017. Epub 2018 Dec 19.
citation: Bordoni R, Ciardiello F, von Pawel J, Cortinovis D, Karagiannis T, Ballinger M, Sandler A, Yu W, He P, Matheny C, Felizzi F, Rittmeyer A. Patient-Reported Outcomes in OAK: A Phase III Study of Atezolizumab Versus Docetaxel in Advanced Non-Small-cell Lung Cancer. Clin Lung Cancer. 2018 Sep;19(5):441-449.e4. doi: 10.1016/j.cllc.2018.05.011. Epub 2018 May 31.
citation: Hida T, Kaji R, Satouchi M, Ikeda N, Horiike A, Nokihara H, Seto T, Kawakami T, Nakagawa S, Kubo T. Atezolizumab in Japanese Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer: A Subgroup Analysis of the Phase 3 OAK Study. Clin Lung Cancer. 2018 Jul;19(4):e405-e415. doi: 10.1016/j.cllc.2018.01.004. Epub 2018 Feb 1.
citation: Rittmeyer A, Barlesi F, Waterkamp D, Park K, Ciardiello F, von Pawel J, Gadgeel SM, Hida T, Kowalski DM, Dols MC, Cortinovis DL, Leach J, Polikoff J, Barrios C, Kabbinavar F, Frontera OA, De Marinis F, Turna H, Lee JS, Ballinger M, Kowanetz M, He P, Chen DS, Sandler A, Gandara DR; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017 Jan 21;389(10066):255-265. doi: 10.1016/S0140-6736(16)32517-X. Epub 2016 Dec 13.