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A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Hoffmann-La Roche
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2017-09-22
Completion Date
2026-10-31
Last Updated
2026-03-09
Healthy Volunteers
No
Conditions
Interventions
Alectinib
Participants will receive 600 mg BID (Cohort A); 900, 1200, or 750 mg BID (Cohort B) or RP2D BID; orally until disease progression, unacceptable toxicity, withdrawal of consent or death.
Atezolizumab
Participants will receive atezolizumab 1200 mg IV infusion Q21D (Cohorts C and F) or 1680 mg IV infusion Q4W starting on Day 29 (Cohort E).
Pemetrexed
Participants will receive pemetrexed 500 mg/m\^2 IV infusion on Day 1 Q21D.
Cisplatin
Participants will receive cisplatin 75 mg/m\^2 IV on Day 1 Q21D.
Carboplatin
Participants will receive carboplatin of AUC 5 or 6 IV on Day 1 Q21D.
Gemcitabine
Participants will receive gemcitabine 1000 or 1250 mg/m\^2 on Days 1 and 8 of every cycle (1 Cycle=21 days).
Entrectinib
Participants will receive entrectinib 600 mg orally QD.
Cobimetinib
Participants will receive 60 mg PO QD on Days 1-21 of the initial run-in and triple-combination periods.
Vemurafenib
Participants will receive 960 mg PO BID on Days 1-21 of the initial run-in period, and 720 mg PO BID on Days 22-28 of the initial run-in period and on Days 1-28 of each cycle during the triple-combination period.
Bevacizumab
Participants will receive 15 mg/kg of IV bevacizumab on Day 1 of each 21-day cycle during the induction and maintenance periods.
Divarasib
Participants will receive divarasib PO QD until disease progression or unacceptable toxicity.
Docetaxel
Participants will receive IV docetaxel Q3W (75 mg/m\^2) until disease progression or unacceptable toxicity
Locations (164)
UC Davis
Sacramento, California, United States
Rocky Mountain Cancer Center
Denver, Colorado, United States
SCRI Florida Cancer Specialists South
Fort Myers, Florida, United States
Florida Cancer Specialist, North Region
St. Petersburg, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Oregon HSU
Portland, Oregon, United States
St. Luke's University Health network
Bethlehem, Pennsylvania, United States
Sarah Cannon Research Institute / Tennessee Oncology
Chattanooga, Tennessee, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, Argentina
Hospital Italiano
Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Royal North Shore Hospital
St Leonards, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, Australia
UZ Brussel
Brussels, Belgium
Cliniques Universitaires St-Luc
Brussels, Belgium
UZ Leuven Gasthuisberg
Leuven, Belgium
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
Ijuí, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Instituto Nacional de Cancer - INCa
Rio de Janeiro, Brazil
Cross Cancer Institute
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
William Osler Health System Brampton Civic Hospital
Brampton, Ontario, Canada
London Health Sciences Centre · Victoria Hospital
London, Ontario, Canada
Lakeridge Health Center
Oshawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
IUCPQ (Hôpital Laval)
Québec, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Bradford Hill Centro de Investigaciones Clinicas
Recoleta, Chile
Beijing Cancer Hospital
Beijing, China
Jilin Cancer Hospital
Changchun, China
Hunan Cancer Hospital
Changsha, China
The second Xiangya hospital of central south university
Changsha, China
Sichuan Cancer Hospital
Chengdu, China
West China Hospital - Sichuan University
Chengdu, China
The First Affiliated Hospital of Guangzhou Medical University Pharmacy
Guangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Shandong Cancer Hospital
Jinan, China
The Second Affiliated Hospital to Nanchang University
Nanchang, China
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Fudan Unviversity Shanghai Cancer Center
Shanghai, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, China
Institut Bergonie CLCC Bordeaux
Bordeaux, France
Centre Francois Baclesse
Caen, France
Centre Oscar Lambret
Lille, France
Centre Léon Bérard
Lyon, France
Hopital Caremeau
Nîmes, France
Hopital Robert Schuman
Nouilly, France
Hôpital Européen Georges Pompidou
Paris, France
Hopital Tenon
Paris, France
CHU Poitiers
Poitiers, France
Hopital Pontchaillou
Rennes, France
CHU de Toulouse - Hôpital Larrey
Toulouse, France
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Asklepios-Fachklinik Muenchen-Gauting
Gauting, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, Germany
HSK Dr.-Horst-Schmidt-Kliniken Klinik für Innere Medizin III Onkologie Hämatologie und Palliativmed
Wiesbaden, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hosp
Shatin, Hong Kong
Soroka Medical Center
Beersheba, Israel
Rambam Health Care Campus
Haifa, Israel
Meir Medical Center
Kfar Saba, Israel
Rabin MC
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Sourasky / Ichilov Hospital; Dept. of Oncology
Tel Aviv, Israel
Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale
Naples, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, Italy
ASST di Cremona - Azienda Socio Sanitaria Territoriale di Cremona
Cremona, Lombardy, Italy
Irccs Istituto Europeo di Oncologia (IEO)
Milan, Lombardy, Italy
Asst Di Monza
Monza, Lombardy, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano (TO), Piedmont, Italy
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Bunkyō City, Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
Kyushu University Hospital
Fukuoka, Japan
Hiroshima University Hospital
Hiroshima, Japan
Kanazawa University Hospital
Ishikawa, Japan
Kanagawa Cancer Center
Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Japan
Shikoku Cancer Center
Matsuyama, Japan
Tohoku University Hospital
Miyagi, Japan
Sendai Kousei Hospital
Miyagi, Japan
Niigata University Medical & Dental Hospital
Niigata, Japan
Niigata Cancer Center Hospital
Niigata, Japan
Kindai University Hospital
Osaka, Japan
Saga University Hospital
Saga, Japan
Shizuoka Cancer Center
Shizuoka, Japan
Juntendo University Hospital
Tokyo, Japan
The Cancer Institute Hospital of JFCR
Tokyo, Japan
Kyorin University Hospital
Tokyo, Japan
Fujita Health University Hospital
Toyoake-shi, Japan
Wakayama Medical University Hospital
Wakayama, Japan
National Hospital Organization Yamaguchi - Ube Medical Center
Yamaguchi, Japan
Hospital Angeles Tijuana
Tijuana, Estado de Baja California, Mexico
Health Pharma Professional Research
Mexico City, Mexico CITY (federal District), Mexico
AVIX Investigación Clínica S.C
Monterrey, Nuevo León, Mexico
Oncologico Potosino
San Luis Potosí City, San Luis Potosí, Mexico
Auckland City Hospital
Auckland, New Zealand
Hemato Oncología de Panamá Especializada
Panama City, Panama
Hospital Nacional Edgardo Rebagliati Martins
Lima, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru
Instituto Peruano de Oncología y Radioterapia
Lima, Peru
Clinica Ricardo Palma
San Isidro, Peru
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Gda?sk, Poland
Krakowski Szpital Specjalistyczny im sw.Jana Pawla II
Krakow, Poland
Warminsko-Mazurskie Centrum Chorób P?uc w Olsztynie
Olsztyn, Poland
Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy
Otwock, Poland
Wielkopolskie Centrum Pulmonologii i Torakochirurgii w Poznaniu
Poznan, Poland
Centrum Onkologii Instytut im.Marii Sklodowskiej-Curie
Warsaw, Poland
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
Principal Military Clinical Hospital n.a. N.N. Burdenko
Moscow, Moscow Oblast, Russia
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint Petersburg, Sankt-Peterburg, Russia
Clinical Oncology Dispensary
Omsk, Russia
Clinical Center of Serbia
Belgrade, Serbia
University Hospital Medical Center Bezanijska kosa
Belgrade, Serbia
Institute for Pulmonary Diseases of Vojvodina
Kamenitz, Serbia
Clinical Center Nis
Niš, Serbia
National University Hospital
Singapore, Singapore
National Cancer Centre
Singapore, Singapore
National Cancer Center
Gyeonggi-do, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Yonsei University Health System/Severance Hospital
Seoul, South Korea
Insititut Catala D'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, LA Coruna, Spain
Clinica Universitaria de Navarra
Pamplona, Navarre, Spain
Hospital General Univ. de Alicante
Alicante, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Clínic i Provincial
Barcelona, Spain
ICO Badalona - Hospital Germans Trias i Pujol
Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Centro Integral Oncologico Clara Campal
Madrid, Spain
Hospital Universitario Puerta de Hierro
Madrid, Spain
Hospital Quiron de Madrid
Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
National Taiwan Uni Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation - Linkou
Taoyuan District, Taiwan
Faculty of Med. Siriraj Hosp.
Bangkok, Thailand
Prince of Songkla University
Hat Yai, Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, Turkey (Türkiye)
Akdeniz University Medical Faculty; Medical Oncology Department
Antalya, Turkey (Türkiye)
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, Turkey (Türkiye)
Medipol University Medical Faculty; Oncology Department
Istanbul, Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital; Medikal Onkoloji
Istanbul, Turkey (Türkiye)
Medikal Park Izmir Hospital
Kar??yaka, Turkey (Türkiye)
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara, Turkey (Türkiye)