Screening Study for Participants With Malignant Tumors

NCT ID: NCT05419375

Last Updated: 2026-01-07

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

15000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2032-12-22

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

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.

Group Type OTHER

Screening platform

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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


* 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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status WITHDRAWN

Rajiv Gandhi Cancer Inst.&Research Center

New Delhi, National Capital Territory of Delhi, India

Site Status WITHDRAWN

Apollo Gleneagles Hospital

Kolkata, West Bengal, India

Site Status WITHDRAWN

Rambam Medical Center

Haifa, , Israel

Site Status COMPLETED

Rabin Medical Center-Beilinson Campus

Petah Tikva, , Israel

Site Status WITHDRAWN

IRCCS Giovanni Paolo II Istituto Oncologico

Bari, Apulia, Italy

Site Status COMPLETED

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

Meldola, Emilia-Romagna, Italy

Site Status WITHDRAWN

IRCCS Istituto Regina Elena (IFO)

Rome, Lazio, Italy

Site Status WITHDRAWN

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, Italy

Site Status COMPLETED

IRCCS A.O.U San MArtino - IST

Genoa, Liguria, Italy

Site Status WITHDRAWN

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy

Site Status WITHDRAWN

Irccs Istituto Europeo di Oncologia (IEO)

Milan, Lombardy, Italy

Site Status WITHDRAWN

Asst Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, Italy

Site Status WITHDRAWN

A.O. Universitaria S. Luigi Gonzaga

Orbassano, Piedmont, Italy

Site Status WITHDRAWN

Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, Italy

Site Status WITHDRAWN

IRCCS Istituto Oncologico Veneto (IOV)

Padua, Veneto, Italy

Site Status WITHDRAWN

Aichi Cancer Center Hospital

Aichi, , Japan

Site Status COMPLETED

Hirosaki University Hospital

Aomori, , Japan

Site Status WITHDRAWN

Shikoku Cancer Center

Ehime, , Japan

Site Status WITHDRAWN

NHO Kyushu Cancer Center

Fukuoka, , Japan

Site Status WITHDRAWN

Kurume University Hospital

Fukuoka, , Japan

Site Status WITHDRAWN

Kobe City Medical Center General Hospital

Hyōgo, , Japan

Site Status COMPLETED

National Hospital Organization Himeji Medical Center

Hyōgo, , Japan

Site Status COMPLETED

Kagoshima University Hospital

Kagoshima, , Japan

Site Status COMPLETED

Kanagawa Cancer Center

Kanagawa, , Japan

Site Status WITHDRAWN

Kumamoto University Hospital

Kumamoto, , Japan

Site Status WITHDRAWN

Sendai Kousei Hospital

Miyagi, , Japan

Site Status WITHDRAWN

Nara Medical University Hospital

Nara, , Japan

Site Status WITHDRAWN

Niigata Cancer Center Hospital

Niigata, , Japan

Site Status WITHDRAWN

Okayama University Hospital

Okayama, , Japan

Site Status WITHDRAWN

Kurashiki Central Hospital

Okayama, , Japan

Site Status WITHDRAWN

Osaka City General Hospital

Osaka, , Japan

Site Status WITHDRAWN

Osaka International Cancer Institute

Osaka, , Japan

Site Status WITHDRAWN

NHO Kinki Chuo Chest Medical Center

Osaka, , Japan

Site Status WITHDRAWN

Kindai University Hospital

Ōsaka-sayama, , Japan

Site Status COMPLETED

Shizuoka Cancer Center

Shizuoka, , Japan

Site Status COMPLETED

Juntendo University Hospital

Tokyo, , Japan

Site Status WITHDRAWN

Komagome Hospital

Tokyo, , Japan

Site Status COMPLETED

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

Site Status COMPLETED

Tottori University Hospital

Tottori, , Japan

Site Status TERMINATED

National Hospital Organization Yamaguchi - Ube Medical Center

Yamaguchi, , Japan

Site Status WITHDRAWN

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Site Status WITHDRAWN

Centro Oncologico Internacional

Mexico City, Mexico CITY (federal District), Mexico

Site Status WITHDRAWN

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), Mexico

Site Status COMPLETED

Centro de Investigación Oncologica Galerias

Aguascalientes, , Mexico

Site Status COMPLETED

ARKE Estudios Clínicos S.A. de C.V.

Mexico City, , Mexico

Site Status WITHDRAWN

Instituto Nacional de Cancerologia

Mexico City, , Mexico

Site Status WITHDRAWN

Maastricht University Medical Center

Maastricht, , Netherlands

Site Status COMPLETED

Auckland City Hospital, Cancer and Blood Research

Auckland, , New Zealand

Site Status COMPLETED

Oslo university hospital Radiumhospitalet

Oslo, , Norway

Site Status WITHDRAWN

Instytut Genetyki i Immunologii GENIM

Lublin, , Poland

Site Status WITHDRAWN

Dolno?l?skie Centrum Chorób P?uc we Wroc?awiu

Wroc?aw, , Poland

Site Status COMPLETED

University Clinical Centre of Serbia

Belgrade, , Serbia

Site Status COMPLETED

Hospital Medical Center Bezanijska kosa

Belgrade, , Serbia

Site Status COMPLETED

Institute for pulmonary diseases of Vojvodina

Kamenitz, , Serbia

Site Status COMPLETED

Univ Clinical Center Kragujevac

Kragujevac, , Serbia

Site Status COMPLETED

National Cancer Centre

Singapore, , Singapore

Site Status WITHDRAWN

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status COMPLETED

Chungbuk National University Hospital

Cheongju-si, , South Korea

Site Status WITHDRAWN

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status WITHDRAWN

Pusan National University Yangsan Hospital

Gyeongsangnam-do, , South Korea

Site Status COMPLETED

Chonnam National University Hwasun Hospital

Jeollanam-do, , South Korea

Site Status COMPLETED

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status COMPLETED

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status COMPLETED

Asan Medical Center

Seoul, , South Korea

Site Status COMPLETED

Korea University Guro Hospital

Seoul, , South Korea

Site Status COMPLETED

Arizona Oncology Associates, PC - HOPE

Tucson, Arizona, United States

Site Status WITHDRAWN

Southern California Kaiser Permanente

San Diego, California, United States

Site Status WITHDRAWN

Rocky Mountain Cancer Centers-Penrose Pavillion

Longmont, Colorado, United States

Site Status WITHDRAWN

Oregon Health Sciences Uni

Portland, Oregon, United States

Site Status WITHDRAWN

Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status WITHDRAWN

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Site Status COMPLETED

Baptist Cancer Center

Memphis, Tennessee, United States

Site Status WITHDRAWN

Texas Oncology, P.A.

Austin, Texas, United States

Site Status COMPLETED

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, United States

Site Status WITHDRAWN

Texas Oncology, P.A.

San Antonio, Texas, United States

Site Status WITHDRAWN

Texas Oncology- Northeast Texas

Tyler, Texas, United States

Site Status COMPLETED

Oncology & Hematology Associates of Southwest Virginia, Inc

Blacksburg, Virginia, United States

Site Status COMPLETED

Northwest Cancer Specialists

Vancouver, Washington, United States

Site Status COMPLETED

Lifehouse

Camperdown, New South Wales, Australia

Site Status WITHDRAWN

GenesisCare North Shore

St Leonards, New South Wales, Australia

Site Status WITHDRAWN

Westmead Hospital

Westmead, New South Wales, Australia

Site Status WITHDRAWN

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status WITHDRAWN

One Clinical Research

Nedlands, Western Australia, Australia

Site Status COMPLETED

GHdC Site Les Viviers

Charleroi, , Belgium

Site Status WITHDRAWN

UZ Gent

Ghent, , Belgium

Site Status WITHDRAWN

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Site Status WITHDRAWN

Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, Brazil

Site Status WITHDRAWN

Oncocentro Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Site Status WITHDRAWN

COT - Centro Oncologico do Triangulo

Uberlândia, Minas Gerais, Brazil

Site Status COMPLETED

Universidade de Caxias do Sul - Rio Grande do Sul

Caxias do Sul, Rio Grande do Sul, Brazil

Site Status WITHDRAWN

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status COMPLETED

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status WITHDRAWN

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status WITHDRAWN

Hospital de Clínicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Clínica de Oncologia Reichow

Blumenau, Santa Catarina, Brazil

Site Status COMPLETED

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Site Status WITHDRAWN

Hospital de Base de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Site Status WITHDRAWN

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Site Status COMPLETED

Oncoclinicas Rio de Janeiro S.A.

Rio de Janeiro, , Brazil

Site Status COMPLETED

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status COMPLETED

K2 Oncology

Providencia, , Chile

Site Status WITHDRAWN

OrlandiOncología

Santiago, , Chile

Site Status WITHDRAWN

Centro de Estudios Clínicos SAGA

Santiago, , Chile

Site Status TERMINATED

RedSalud Vitacura

Santiago, , Chile

Site Status RECRUITING

James Lind Centro de Investigación Del Cáncer

Temuco, , Chile

Site Status WITHDRAWN

Clinica De La Costa

Barranquilla, , Colombia

Site Status COMPLETED

Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogota, D.C., , Colombia

Site Status WITHDRAWN

Hospital Universitario San Ignacio

Bogotá, , Colombia

Site Status COMPLETED

Instituto Cancerología Medellin

Medellín, , Colombia

Site Status COMPLETED

Clinica CIMCA

San José, , Costa Rica

Site Status COMPLETED

ICIMED Instituto de Investigación en Ciencias Médicas

San José, , Costa Rica

Site Status COMPLETED

CHU Angers,Service de Pneumologie

Angers, , France

Site Status WITHDRAWN

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

Site Status WITHDRAWN

Centre Francois Baclesse

Caen, , France

Site Status WITHDRAWN

Centre Leon Berard

Lyon, , France

Site Status COMPLETED

Hopital Haut Leveque Chu de Bordeaux

Pessac, , France

Site Status WITHDRAWN

CHU Strasbourg - Nouvel Hopital Civil

Strasbourg, , France

Site Status WITHDRAWN

Hia Sainte Anne

Toulon, , France

Site Status COMPLETED

Zentralklinikum Augsburg

Augsburg, , Germany

Site Status WITHDRAWN

Klinikum Esslingen

Esslingen am Neckar, , Germany

Site Status WITHDRAWN

LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik V, Campus Innenstadt

München, , Germany

Site Status WITHDRAWN

Klinikum rechts der Isar der TU Muenchen

München, , Germany

Site Status COMPLETED

Asklepios Klinik Gauting

München-Gauting, , Germany

Site Status COMPLETED

Universitätsklinikum Regensburg

Regensburg, , Germany

Site Status WITHDRAWN

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status RECRUITING

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status COMPLETED

Complejo Hospitalario Universitario Insular?Materno Infantil

Las Palmas de Gran Canaria, LAS Palmas, Spain

Site Status WITHDRAWN

Hospital General Univ. de Alicante

Alicante, , Spain

Site Status WITHDRAWN

Hospital Universitario La Paz

Madrid, , Spain

Site Status WITHDRAWN

Hospital Regional Universitario Carlos Haya

Málaga, , Spain

Site Status COMPLETED

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status WITHDRAWN

Taipei Medical University Shuang Ho Hospital

New Taipei City, , Taiwan

Site Status WITHDRAWN

National Cheng Kung Univ Hosp

Tainan, , Taiwan

Site Status COMPLETED

National Taiwan Uni Hospital

Taipei, , Taiwan

Site Status COMPLETED

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status COMPLETED

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status COMPLETED

Taipei Municipal Wan Fang Hospital

Taipei, , Taiwan

Site Status COMPLETED

Chang Gung Memorial Hospital - Linkou

Taoyuan District, , Taiwan

Site Status COMPLETED

Taichung Veterans General Hospital

Xitun Dist., , Taiwan

Site Status COMPLETED

National Cancer Institute

Bangkok, , Thailand

Site Status COMPLETED

Rajavithi Hospital

Bangkok, , Thailand

Site Status COMPLETED

Siriraj Hospital

Bangkok, , Thailand

Site Status TERMINATED

Maharaj Nakorn Chiang Mai Hosp

Chang Mai, , Thailand

Site Status WITHDRAWN

Oncology Unit, Faculty of Medicine, Vajira Hospital

Dusit, , Thailand

Site Status COMPLETED

Srinagarind Hospital

Khon Kaen, , Thailand

Site Status COMPLETED

Central Chest Institute of Thailand

Nonthaburi, , Thailand

Site Status COMPLETED

Songklanagarind Hospital

Songkhla, , Thailand

Site Status COMPLETED

Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi

Ankara, , Turkey (Türkiye)

Site Status COMPLETED

Gazi Uni Medical Faculty Hospital

Ankara, , Turkey (Türkiye)

Site Status COMPLETED

Liv Hospital Ankara

Ankara, , Turkey (Türkiye)

Site Status COMPLETED

Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

Bakirkoy / Istanbul, , Turkey (Türkiye)

Site Status COMPLETED

Dicle University Faculty of Medicine

Diyarbakır, , Turkey (Türkiye)

Site Status COMPLETED

Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

Erzurum, , Turkey (Türkiye)

Site Status COMPLETED

Medipol University Medical Faculty

Istanbul, , Turkey (Türkiye)

Site Status COMPLETED

Marmara Uni Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status TERMINATED

Medikal Park Samsun

Samsun, , Turkey (Türkiye)

Site Status COMPLETED

Medical Park Seyhan Hospital

Seyhan, , Turkey (Türkiye)

Site Status COMPLETED

Barts & London School of Med

London, , United Kingdom

Site Status COMPLETED

Royal Marsden Hospital

London, , United Kingdom

Site Status WITHDRAWN

Christie Hospital Nhs Trust

Manchester, , United Kingdom

Site Status WITHDRAWN

Countries

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United States Australia Belgium Brazil Canada Chile Colombia Costa Rica France Germany Hong Kong India Israel Italy Japan Mexico Netherlands New Zealand Norway Poland Serbia Singapore South Korea Spain Taiwan Thailand Turkey (Türkiye) United Kingdom

Central Contacts

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Reference Study ID Number: BX43361 https://forpatients.roche.com

Role: CONTACT

1-888-662-6728

Other Identifiers

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BX43361

Identifier Type: -

Identifier Source: org_study_id

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