Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
15000 participants
INTERVENTIONAL
2022-07-22
2032-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Non-Small Cell Lung Cancer (NSCLC)
Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.
Screening platform
The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.
Interventions
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Screening platform
The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.
Eligibility Criteria
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Inclusion Criteria
* Considered by principal investigator (PI) to be a candidate for a linked clinical trial with an investigational medicinal product, and that the participant has the awareness and willingness to participate in said trial
* Locally advanced, unresectable Stage III NSCLC of either squamous or non-squamous histology based on 8th edition of the American Joint Committee on Cancer (AJCC) and Union for International Cancer Control (UICC) cancer staging system
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Stage II, IIIA, or select IIIB (T3N2 only) NSCLC based on the 8th edition of the AJCC and UICC cancer staging system (Amin et al. 2017)
* Considered eligible for curative intent surgery (complete resection with all surgical margins testing negative for tumor)
* Screening within Study BX43361, using a pretreatment biopsy, is encouraged to be performed as early in the participant treatment pathway as possible to ensure the participant is potentially eligible for all cohorts, and should meet guidelines as defined by the protocol
* Representative FFPE tumor specimen obtained prior to the start of any treatment
* ECOG Performance Status of 0 or 1
Exclusion Criteria
* Any condition that may affect the interpretation of study results
* Significant liver or cardiovascular disease
* Prior allogenic stem-cell or solid-organ transplantation
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Medanta -The Medicity
Gurgaon, Haryana, India
Tata Memorial Hospital
Mumbai, Maharashtra, India
Rajiv Gandhi Cancer Inst.&Research Center
New Delhi, National Capital Territory of Delhi, India
Apollo Gleneagles Hospital
Kolkata, West Bengal, India
Rambam Medical Center
Haifa, , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
IRCCS Giovanni Paolo II Istituto Oncologico
Bari, Apulia, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, Italy
IRCCS Istituto Regina Elena (IFO)
Rome, Lazio, Italy
Azienda Ospedaliera San Camillo Forlanini
Rome, Lazio, Italy
IRCCS A.O.U San MArtino - IST
Genoa, Liguria, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy
Irccs Istituto Europeo di Oncologia (IEO)
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
A.O. Universitaria S. Luigi Gonzaga
Orbassano, Piedmont, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
IRCCS Istituto Oncologico Veneto (IOV)
Padua, Veneto, Italy
Aichi Cancer Center Hospital
Aichi, , Japan
Hirosaki University Hospital
Aomori, , Japan
Shikoku Cancer Center
Ehime, , Japan
NHO Kyushu Cancer Center
Fukuoka, , Japan
Kurume University Hospital
Fukuoka, , Japan
Kobe City Medical Center General Hospital
Hyōgo, , Japan
National Hospital Organization Himeji Medical Center
Hyōgo, , Japan
Kagoshima University Hospital
Kagoshima, , Japan
Kanagawa Cancer Center
Kanagawa, , Japan
Kumamoto University Hospital
Kumamoto, , Japan
Sendai Kousei Hospital
Miyagi, , Japan
Nara Medical University Hospital
Nara, , Japan
Niigata Cancer Center Hospital
Niigata, , Japan
Okayama University Hospital
Okayama, , Japan
Kurashiki Central Hospital
Okayama, , Japan
Osaka City General Hospital
Osaka, , Japan
Osaka International Cancer Institute
Osaka, , Japan
NHO Kinki Chuo Chest Medical Center
Osaka, , Japan
Kindai University Hospital
Ōsaka-sayama, , Japan
Shizuoka Cancer Center
Shizuoka, , Japan
Juntendo University Hospital
Tokyo, , Japan
Komagome Hospital
Tokyo, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Tottori University Hospital
Tottori, , Japan
National Hospital Organization Yamaguchi - Ube Medical Center
Yamaguchi, , Japan
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Centro Oncologico Internacional
Mexico City, Mexico CITY (federal District), Mexico
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico
Centro de Investigación Oncologica Galerias
Aguascalientes, , Mexico
ARKE Estudios Clínicos S.A. de C.V.
Mexico City, , Mexico
Instituto Nacional de Cancerologia
Mexico City, , Mexico
Maastricht University Medical Center
Maastricht, , Netherlands
Auckland City Hospital, Cancer and Blood Research
Auckland, , New Zealand
Oslo university hospital Radiumhospitalet
Oslo, , Norway
Instytut Genetyki i Immunologii GENIM
Lublin, , Poland
Dolno?l?skie Centrum Chorób P?uc we Wroc?awiu
Wroc?aw, , Poland
University Clinical Centre of Serbia
Belgrade, , Serbia
Hospital Medical Center Bezanijska kosa
Belgrade, , Serbia
Institute for pulmonary diseases of Vojvodina
Kamenitz, , Serbia
Univ Clinical Center Kragujevac
Kragujevac, , Serbia
National Cancer Centre
Singapore, , Singapore
Tan Tock Seng Hospital
Singapore, , Singapore
Chungbuk National University Hospital
Cheongju-si, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Pusan National University Yangsan Hospital
Gyeongsangnam-do, , South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, , South Korea
Seoul National University Bundang Hospital
Seongnam-si, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Southern California Kaiser Permanente
San Diego, California, United States
Rocky Mountain Cancer Centers-Penrose Pavillion
Longmont, Colorado, United States
Oregon Health Sciences Uni
Portland, Oregon, United States
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Texas Oncology, P.A.
Austin, Texas, United States
Mays Cancer Center, UT Health San Antonio
San Antonio, Texas, United States
Texas Oncology, P.A.
San Antonio, Texas, United States
Texas Oncology- Northeast Texas
Tyler, Texas, United States
Oncology & Hematology Associates of Southwest Virginia, Inc
Blacksburg, Virginia, United States
Northwest Cancer Specialists
Vancouver, Washington, United States
Lifehouse
Camperdown, New South Wales, Australia
GenesisCare North Shore
St Leonards, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
One Clinical Research
Nedlands, Western Australia, Australia
GHdC Site Les Viviers
Charleroi, , Belgium
UZ Gent
Ghent, , Belgium
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil
Oncocentro Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
COT - Centro Oncologico do Triangulo
Uberlândia, Minas Gerais, Brazil
Universidade de Caxias do Sul - Rio Grande do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre X
Porto Alegre, Rio Grande do Sul, Brazil
Clínica de Oncologia Reichow
Blumenau, Santa Catarina, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Oncoclinicas Rio de Janeiro S.A.
Rio de Janeiro, , Brazil
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
K2 Oncology
Providencia, , Chile
OrlandiOncología
Santiago, , Chile
Centro de Estudios Clínicos SAGA
Santiago, , Chile
RedSalud Vitacura
Santiago, , Chile
James Lind Centro de Investigación Del Cáncer
Temuco, , Chile
Clinica De La Costa
Barranquilla, , Colombia
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., , Colombia
Hospital Universitario San Ignacio
Bogotá, , Colombia
Instituto Cancerología Medellin
Medellín, , Colombia
Clinica CIMCA
San José, , Costa Rica
ICIMED Instituto de Investigación en Ciencias Médicas
San José, , Costa Rica
CHU Angers,Service de Pneumologie
Angers, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Centre Leon Berard
Lyon, , France
Hopital Haut Leveque Chu de Bordeaux
Pessac, , France
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, , France
Hia Sainte Anne
Toulon, , France
Zentralklinikum Augsburg
Augsburg, , Germany
Klinikum Esslingen
Esslingen am Neckar, , Germany
LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik V, Campus Innenstadt
München, , Germany
Klinikum rechts der Isar der TU Muenchen
München, , Germany
Asklepios Klinik Gauting
München-Gauting, , Germany
Universitätsklinikum Regensburg
Regensburg, , Germany
Universitätsklinikum Würzburg
Würzburg, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Complejo Hospitalario Universitario Insular?Materno Infantil
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital General Univ. de Alicante
Alicante, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Taipei Medical University Shuang Ho Hospital
New Taipei City, , Taiwan
National Cheng Kung Univ Hosp
Tainan, , Taiwan
National Taiwan Uni Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan District, , Taiwan
Taichung Veterans General Hospital
Xitun Dist., , Taiwan
National Cancer Institute
Bangkok, , Thailand
Rajavithi Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hosp
Chang Mai, , Thailand
Oncology Unit, Faculty of Medicine, Vajira Hospital
Dusit, , Thailand
Srinagarind Hospital
Khon Kaen, , Thailand
Central Chest Institute of Thailand
Nonthaburi, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Gazi Uni Medical Faculty Hospital
Ankara, , Turkey (Türkiye)
Liv Hospital Ankara
Ankara, , Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, , Turkey (Türkiye)
Dicle University Faculty of Medicine
Diyarbakır, , Turkey (Türkiye)
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum, , Turkey (Türkiye)
Medipol University Medical Faculty
Istanbul, , Turkey (Türkiye)
Marmara Uni Faculty of Medicine
Istanbul, , Turkey (Türkiye)
Medikal Park Samsun
Samsun, , Turkey (Türkiye)
Medical Park Seyhan Hospital
Seyhan, , Turkey (Türkiye)
Barts & London School of Med
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Christie Hospital Nhs Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: BX43361 https://forpatients.roche.com
Role: CONTACT
Other Identifiers
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BX43361
Identifier Type: -
Identifier Source: org_study_id
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