Clinical trial NCT05419375: Screening Study for Participants With Malignant Tumors
Official title: Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Solid Tumors
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2022-06-15
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study objective is to determine the biomarker status of a participant's tumor tissue and use that status to determine eligibility for a linked Roche clinical trial.


Eligibility criteria: General Inclusion Criteria:

* Confirmed availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen meeting criteria defined in the protocol
* 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

Inclusion Criteria for Participants with Stage III NSCLC

* 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

Inclusion Criteria for Participants with Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC Requiring Adjuvant Treatment

* 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

General Exclusion Criteria:

* History of malignancy other than NSCLC within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death
* Any condition that may affect the interpretation of study results
* Significant liver or cardiovascular disease
* Prior allogenic stem-cell or solid-organ transplantation

Primary outcomes:
measure: Proportion of participants with evaluable biomarker results
timeFrame: Up to 10 years
measure: Proportion of participants eligible for a linked Roche clinical trial
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates, PC - HOPE
state: Arizona
city: San Diego
country: United States
facility: Southern California Kaiser Permanente
state: California
city: Longmont
country: United States
facility: Rocky Mountain Cancer Centers-Penrose Pavillion
state: Colorado
city: Portland
country: United States
facility: Oregon Health Sciences Uni
state: Oregon
city: Pittsburgh
country: United States
facility: Hillman Cancer Center
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Memphis
country: United States
facility: Baptist Cancer Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: San Antonio
country: United States
facility: Mays Cancer Center, UT Health San Antonio
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Tyler
country: United States
facility: Texas Oncology- Northeast Texas
state: Texas
city: Blacksburg
country: United States
facility: Oncology & Hematology Associates of Southwest Virginia, Inc
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
city: Camperdown
country: Australia
facility: Lifehouse
state: New South Wales
city: St Leonards
country: Australia
facility: GenesisCare North Shore
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Nedlands
country: Australia
facility: One Clinical Research
state: Western Australia
city: Charleroi
country: Belgium
facility: GHdC Site Les Viviers
city: Gent
country: Belgium
facility: UZ Gent
city: Salvador
country: Brazil
facility: Hospital Sao Rafael - HSR
state: Bahia
city: Fortaleza
country: Brazil
facility: Crio - Centro Regional Integrado de Oncologia
state: Ceará
city: Belo Horizonte
country: Brazil
facility: Oncocentro Belo Horizonte
state: Minas Gerais
city: Uberlandia
country: Brazil
facility: COT - Centro Oncologico do Triangulo
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Clínica de Oncologia Reichow
state: Santa Catarina
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: São Paulo
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose do Rio Preto
state: São Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Oncoclinicas Rio de Janeiro S.A.
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Providencia
country: Chile
facility: K2 Oncology
city: Santiago
country: Chile
facility: OrlandiOncología
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos SAGA
city: Santiago
country: Chile
facility: RedSalud Vitacura
city: Temuco
country: Chile
facility: James Lind Centro de Investigación Del Cáncer
city: Barranquilla
country: Colombia
facility: Clinica De La Costa
city: Bogota, D.C.
country: Colombia
facility: Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio
city: Medellin
country: Colombia
facility: Instituto Cancerología Medellin
city: San José
country: Costa Rica
facility: Clinica CIMCA
city: San José
country: Costa Rica
facility: ICIMED Instituto de Investigación en Ciencias Médicas
city: Angers
country: France
facility: CHU Angers,Service de Pneumologie
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Caen
country: France
facility: Centre Francois Baclesse
city: Lyon
country: France
facility: Centre Leon Berard
city: Strasbourg
country: France
facility: CHU Strasbourg - Nouvel Hopital Civil
city: Toulon
country: France
facility: Hia Sainte Anne
city: Augsburg
country: Germany
facility: Zentralklinikum Augsburg
city: Esslingen
country: Germany
facility: Klinikum Esslingen
city: München-Gauting
country: Germany
facility: Asklepios Klinik Gauting
city: München
country: Germany
facility: LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik V, Campus Innenstadt
city: München
country: Germany
facility: Klinikum rechts der Isar der TU Muenchen
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Inst.&Research Center
state: Delhi
city: Gurgaon
country: India
facility: Medanta -The Medicity
state: Haryana
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
city: Kolkata
country: India
facility: Apollo Gleneagles Hospital
state: WEST Bengal
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center-Beilinson Campus
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
state: Emilia-Romagna
city: Roma
country: Italy
facility: IRCCS Istituto Regina Elena (IFO)
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
state: Lazio
city: Genova
country: Italy
facility: IRCCS A.O.U San MArtino - IST
state: Liguria
city: Brescia
country: Italy
facility: Asst Degli Spedali Civili Di Brescia
state: Lombardia
city: Milano
country: Italy
facility: Irccs Istituto Europeo di Oncologia (IEO)
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda
state: Lombardia
city: Orbassano
country: Italy
facility: A.O. Universitaria S. Luigi Gonzaga
state: Piemonte
city: Bari
country: Italy
facility: IRCCS Giovanni Paolo II Istituto Oncologico
state: Puglia
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
state: Toscana
city: Padova
country: Italy
facility: IRCCS Istituto Oncologico Veneto (IOV)
state: Veneto
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital
city: Aomori
country: Japan
facility: Hirosaki University Hospital
city: Ehime
country: Japan
facility: Shikoku Cancer Center
city: Fukuoka
country: Japan
facility: NHO Kyushu Cancer Center
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital
city: Hyogo
country: Japan
facility: National Hospital Organization Himeji Medical Center
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital
city: Kanagawa
country: Japan
facility: Kanagawa Cancer Center
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Miyagi
country: Japan
facility: Sendai Kousei Hospital
city: Nara
country: Japan
facility: Nara Medical University Hospital
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okayama
country: Japan
facility: Kurashiki Central Hospital
city: Osaka-sayama
country: Japan
facility: Kindai University Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Osaka
country: Japan
facility: NHO Kinki Chuo Chest Medical Center
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Komagome Hospital
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tottori
country: Japan
facility: Tottori University Hospital
city: Yamaguchi
country: Japan
facility: National Hospital Organization Yamaguchi - Ube Medical Center
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Gyeongsangnam-do
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Jeollanam-do
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
city: Mexico City
country: Mexico
facility: Clinstile S.A de C.V.
state: Mexico CITY (federal District)
city: Aguascalientes
country: Mexico
facility: Centro de Investigación Oncologica Galerias
city: Ciudad de México
country: Mexico
facility: ARKE Estudios Clínicos S.A. de C.V.
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cancerologia
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital, Cancer and Blood Research
city: Oslo
country: Norway
facility: Oslo university hospital Radiumhospitalet
city: Lublin
country: Poland
facility: Instytut Genetyki i Immunologii GENIM
city: Wroc?aw
country: Poland
facility: Dolno?l?skie Centrum Chorób P?uc we Wroc?awiu
city: Belgrade
country: Serbia
facility: University Clinical Centre of Serbia
city: Belgrade
country: Serbia
facility: Hospital Medical Center Bezanijska kosa
city: Kragujevac
country: Serbia
facility: Univ Clinical Center Kragujevac
city: Sremska Kamenica
country: Serbia
facility: Institute for pulmonary diseases of Vojvodina
city: Singapore
country: Singapore
facility: National Cancer Centre
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Las Palmas de Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular?Materno Infantil
state: LAS Palmas
city: Alicante
country: Spain
facility: Hospital General Univ. de Alicante
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung Univ Hosp
city: Taipei City
country: Taiwan
facility: National Taiwan Uni Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Municipal Wan Fang Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
city: Xitun Dist.
country: Taiwan
facility: Taichung Veterans General Hospital
city: Bangkok
country: Thailand
facility: National Cancer Institute
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hosp
city: Dusit
country: Thailand
facility: Oncology Unit, Faculty of Medicine, Vajira Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
city: Nonthaburi
country: Thailand
facility: Central Chest Institute of Thailand
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital
city: Ankara
country: Turkey
facility: Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
city: Ankara
country: Turkey
facility: Gazi Uni Medical Faculty Hospital
city: Ankara
country: Turkey
facility: Liv Hospital Ankara
city: Bakirkoy / Istanbul
country: Turkey
facility: Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
city: Diyarbakir
country: Turkey
facility: Dicle University Faculty of Medicine
city: Erzurum
country: Turkey
facility: Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
city: Istanbul
country: Turkey
facility: Medipol University Medical Faculty
city: Istanbul
country: Turkey
facility: Marmara Uni Faculty of Medicine
city: Samsun
country: Turkey
facility: Medikal Park Samsun
city: Seyhan
country: Turkey
facility: Medical Park Seyhan Hospital
city: London
country: United Kingdom
facility: Barts & London School of Med
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: Christie Hospital Nhs Trust
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: