Clinical trial NCT03178552: A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 1000
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 is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Measurable disease
* Adequate recovery from most recent systemic or local treatment for cancer
* Adequate organ function
* Life expectancy greater than or equal to (\>/=) 12 weeks
* For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception

Exclusion Criteria:

* Inability to swallow oral medication
* Women who are pregnant or lactating
* Symptomatic, untreated CNS metastases
* History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
* Known active or uncontrolled human immunodeficiency virus (HIV) infection
* Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study
* Inability to comply with other requirements of the protocol

Primary outcomes:
measure: Cohort A: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohort B: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohort C: Progression Free Survival (PFS) as Assessed by the Investigator Based on RECIST v1.1 in bTMB PP1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohort D: Percentage of Participants with Confirmed Objective Response as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohort E: Time in Response (TIR) as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Month 12
measure: Cohort F: Investigator-Assessed Objective Response Rate (ORR) Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohort G: Incidence of Adverse Events (AEs)
timeFrame: Baseline to last dose of study treatment + 30 days or until initiation of new anticancer therapy, whichever occurs first (up to approximately 6 years)
Secondary outcomes:
measure: Cohorts A-F: Duration of Response (DOR) as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohorts A, B, D, F: PFS as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohorts A-F: Duration of Response as Assessed by the Independent Review Facility (IRF) Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohorts A, B and D: Percentage of Participants with Clinical Benefit Response as Assessed by IRF Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohorts A-F: PFS as Assessed by IRF Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohorts A-F: Percentage of Participants with Confirmed Objective Response as Assessed by IRF Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohorts A-F: Overall Survival (OS)
timeFrame: Baseline up to approximately 6 years
measure: Cohorts A-F: Percentage of Participants with Adverse Events (AEs)
timeFrame: Baseline up to approximately 6 years
measure: Cohorts A, B, D, E, F: Percentage of Participants with Improvement Compared with Baseline in Total Severity Symptom Score as Measured by Symptoms in Lung Cancer (SILC) Scale in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain)
timeFrame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
measure: Cohorts A-F: Time to Deterioration in Patient-Reported Lung Cancer Symptoms (Cough, Dyspnea and Chest Pain) as Measured by the SILC Scale
timeFrame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
measure: Cohorts C, E, F: Change from Baseline in Patient-Reported Lung Cancer Symptom (Cough, Dyspnea, Chest pain) Score as Measured by the SILC Scale
timeFrame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
measure: Cohorts A-F: Change from Baseline in Health Related Quality of Life (HRQoL) Scores as Measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - C30 (EORTC QLQ-C30)
timeFrame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
measure: Cohorts A, B, D, E, F: Change from Baseline in HRQoL Scores as Measured by the SILC Scale
timeFrame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
measure: Cohorts A-F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the EORTC QLQ-C30
timeFrame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
measure: Cohorts A, B, D, E, F: Change from Baseline in Patient Functioning and Symptoms Score as Measured by the SILC Scale
timeFrame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
measure: Cohorts A-F: Health Status Assessed as an Index Score Using the European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
timeFrame: Baseline, every 4 weeks through Cycle 6 (1 Cycle = 21 or 28 days), every 8 weeks thereafter up to approximately 6 years
measure: Cohort B: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
timeFrame: Day 1 to Day 28 of Cycle 1 (cycle length = 28 days)
measure: Cohort B: Maximum Plasma Concentration (Cmax) of Alectinib
timeFrame: DFP: pre-dose (0 hours [hr]) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
measure: Cohort B: Area Under the Concentration-Time Curve from Time Zero to the Last Measurable Concentration (AUC0-last) of Alectinib
timeFrame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
measure: Cohort B: Time to Reach Cmax (Tmax) of Alectinib
timeFrame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
measure: Cohort B: Half-Life (t1/2) of Alectinib
timeFrame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
measure: Cohort B: Metabolite to Parent Exposure Ratio for AUC0-last
timeFrame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
measure: Cohort B: Metabolite to Parent Exposure Ratio for Cmax
timeFrame: DFP: pre-dose (0 hr) on Day 1 of Cycle 2; 0.5, 1, 2, 4, 6, 8 and 10 hr post-dose on Day 1 of Cycle 2 (1 Cycle=28 days)
measure: Cohort C: Percentage of Participants with Objective Response as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohort C: Percentage of Participants Free from Disease Progression as Assessed by the Investigator Based on RECIST v1.1 at Months 6 and 12
timeFrame: Months 6, 12
measure: Cohort C: PFS as Assessed by the Investigator based on RECIST v1.1 in bTMB PP2
timeFrame: Baseline up to disease progression or death (up to approximately 6 years)
measure: Cohort C: OS in bTMB PP2
timeFrame: Baseline up to approximately 6 years
measure: Cohort D: Time to CNS progression as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Baseline up to CNS progression (up to approximately 6 years)
measure: Cohort D: Time to CNS progression as Assessed by the IRF Based on RECIST v1.1
timeFrame: Baseline up to CNS progression (up to approximately 6 years)
measure: Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-C30
timeFrame: Baseline, every 4 weeks until disease progression, up to approximately 6 years
measure: Cohort D: Percentage of Participants who have shown improvement compared with Baseline in patient-reported cognitive function, fatigue, HRQoL, headache and vision disorder per the EORTC QLQ-BN20
timeFrame: Baseline, every 4 weeks until disease progression, up to approximately 6 years
measure: Cohort D: Mean Plasma Concentration of Entrectinib
timeFrame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days).
measure: Cohort D: Mean Plasma Concentration of Entrectinib Metabolite M5
timeFrame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days).
measure: Cohort E: TIR as Assessed by the Investigator Based on RECIST v1.1
timeFrame: Month 9
measure: Cohort E: TIR as Assessed by IRF
timeFrame: Month 12
measure: Cohorts E, F: Serum Concentration of Atezolizumab
timeFrame: Pre-dose (0 hr), 1.5 and 4 hr post-dose on Day 1 of Cycles 1, 2, 3, 4 and 5; and pre-dose on Day 1 of each subsequent treatment cycle (1 cycle = 28 days)
measure: Cohorts E, F: Change from Baseline in Anti-Drug Antibodies (ADAs)
timeFrame: Baseline up to approximately 6 years
measure: Cohorts E, F: Time to Confirmed Deterioration (TTCD) in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the Symptoms in Lung Cancer (SILC)
timeFrame: Baseline up to approximately 6 years
measure: Cohorts E, F: Proportion of Participants who Improve Compared with Baseline in Participant-Reported Lung Cancer Symptoms of Cough, Dyspnea, and Chest Pain, as Measured by the SILC
timeFrame: Baseline up to approximately 6 years
measure: Cohort G: Plasma Concentration of Divarasib
timeFrame: Baseline up to approximately 6 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Fort Myers
country: United States
facility: SCRI Florida Cancer Specialists South
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialist, North Region
state: Florida
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian Hospital
state: New York
city: Portland
country: United States
facility: Oregon HSU
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health network
state: Pennsylvania
city: Chattanooga
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute / Tennessee Oncology
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Fundación CENIT para la Investigación en Neurociencias
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Kurralta Park
country: Australia
facility: Ashford Cancer Center Research
state: South Australia
city: Brussel
country: Belgium
facility: UZ Brussel
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Ijui
country: Brazil
facility: Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Barrie
country: Canada
facility: Royal Victoria Regional Health Centre
state: Ontario
city: Brampton
country: Canada
facility: William Osler Health System Brampton Civic Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre · Victoria Hospital
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health Center
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Quebec City
country: Canada
facility: IUCPQ (Hôpital Laval)
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Recoleta
country: Chile
facility: Bradford Hill Centro de Investigaciones Clinicas
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Changchun
country: China
facility: Jilin Cancer Hospital
city: Changsha City
country: China
facility: Hunan Cancer Hospital
city: Changsha City
country: China
facility: The second Xiangya hospital of central south university
city: Chengdu City
country: China
facility: Sichuan Cancer Hospital
city: Chengdu City
country: China
facility: West China Hospital - Sichuan University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University Pharmacy
city: Hangzhou City
country: China
facility: Zhejiang Cancer Hospital
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital to Nanchang University
city: Nanjing City
country: China
facility: Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
city: Shanghai
country: China
facility: Fudan Unviversity Shanghai Cancer Center
city: Xi'an
country: China
facility: First Affiliated Hospital of Medical College of Xi'an Jiaotong University
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Léon Bérard
city: Nimes
country: France
facility: Hopital Caremeau
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hopital Tenon
city: Poitiers
country: France
facility: CHU Poitiers
city: Rennes
country: France
facility: Hopital Pontchaillou
city: Toulouse Cedex 9
country: France
facility: CHU de Toulouse - Hôpital Larrey
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH
city: Gauting
country: Germany
facility: Asklepios-Fachklinik Muenchen-Gauting
city: Heidelberg
country: Germany
facility: Thoraxklinik Heidelberg gGmbH
city: Wiesbaden
country: Germany
facility: HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hosp
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Petach Tikva
country: Israel
facility: Rabin MC
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky / Ichilov Hospital; Dept. of Oncology
city: Napoli
country: Italy
facility: Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
state: Campania
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO)
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Bergamo
country: Italy
facility: Asst Papa Giovanni XXIII
state: Lombardia
city: Cremona
country: Italy
facility: ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo di Oncologia (IEO)
state: Lombardia
city: Monza
country: Italy
facility: Asst Di Monza
state: Lombardia
city: Orbassano (TO)
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga
state: Piemonte
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Matsuyama-shi
country: Japan
facility: Shikoku Cancer Center
city: Miyagi
country: Japan
facility: Tohoku University Hospital
city: Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital
city: Niigata
country: Japan
facility: Niigata University Medical & Dental Hospital
city: Osaka
country: Japan
facility: Kindai University Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: Kyorin University Hospital
city: Toyoake-shi
country: Japan
facility: Fujita Health University Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamaguchi
country: Japan
facility: National Hospital Organization Yamaguchi - Ube Medical Center
city: Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System/Severance Hospital
city: Tijuana
country: Mexico
facility: Hospital Angeles Tijuana
state: BAJA California
city: Cdmx
country: Mexico
facility: Health Pharma Professional Research
state: Mexico CITY (federal District)
city: Monterrey
country: Mexico
facility: AVIX Investigación Clínica S.C
state: Nuevo LEON
city: San Luis Potosí
country: Mexico
facility: Oncologico Potosino
state: SAN LUIS Potosi
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Panama City
country: Panama
facility: Hemato Oncología de Panamá Especializada
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas
city: Lima
country: Peru
facility: Instituto Peruano de Oncología y Radioterapia
city: San Isidro
country: Peru
facility: Clinica Ricardo Palma
city: Olsztyn
country: Poland
facility: Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
city: Otwock
country: Poland
facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
city: Warszawa
country: Poland
facility: Narod.Inst.Onkol. im. M.Sklodowskiej - Curie-Panst.Inst.Bad
city: Moscovskaya Oblast
country: Russian Federation
facility: Moscow City Oncology Hospital #62
state: Moskovskaja Oblast
city: Saint-Petersburg
country: Russian Federation
facility: S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
state: Sankt Petersburg
city: Omsk
country: Russian Federation
facility: Clinical Oncology Dispensary
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: University Hospital Medical Center Bezanijska kosa
city: NIS
country: Serbia
facility: Clinical Center Nis
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Hospitalet de Llobregat
country: Spain
facility: Insititut Catala D'Oncologia
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS)
state: LA Coruna
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Alicante
country: Spain
facility: Hospital General Univ. de Alicante
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínic i Provincial
city: Barcelona
country: Spain
facility: ICO Badalona - Hospital Germans Trias i Pujol
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Quiron de Madrid
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.
city: Hat Yai
country: Thailand
facility: Prince of Songkla University
city: Adana
country: Turkey
facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty; Medical Oncology Department
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty; Oncology Department
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital; Medikal Onkoloji
city: Kar??yaka
country: Turkey
facility: Medikal Park Izmir Hospital
city: Sihhiye/Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Peters S, Dziadziuszko R, Morabito A, Felip E, Gadgeel SM, Cheema P, Cobo M, Andric Z, Barrios CH, Yamaguchi M, Dansin E, Danchaivijitr P, Johnson M, Novello S, Mathisen MS, Shagan SM, Schleifman E, Wang J, Yan M, Mocci S, Voong D, Fabrizio DA, Shames DS, Riehl T, Gandara DR, Mok T. Atezolizumab versus chemotherapy in advanced or metastatic NSCLC with high blood-based tumor mutational burden: primary analysis of BFAST cohort C randomized phase 3 trial. Nat Med. 2022 Sep;28(9):1831-1839. doi: 10.1038/s41591-022-01933-w. Epub 2022 Aug 22.