Screening Study for Participants With Malignant Tumors

NCT05419375 | Completed Phase 2

• 1 other identifier: BX43361
• Study Type: interventional
• Target: 470
• Locations: 25 countries
• Sites: 77

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with evaluable biomarker results

  Up to 10 years

• Proportion of participants eligible for a linked Roche clinical trial

  Up to 10 years

Study Arms (1)

Non-Small Cell Lung Cancer (NSCLC)

OTHER

Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.

Other: Screening platform

Interventions

Screening platform OTHER

The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.

Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (79)

Thompson Cancer Survival Center

Knoxville, Tennessee, 37916-2305, United States

Location

Texas Oncology, P.A.

Austin, Texas, 78745, United States

Location

Texas Oncology- Northeast Texas

Tyler, Texas, 75702, United States

Location

Oncology & Hematology Associates of Southwest Virginia, Inc

Blacksburg, Virginia, 24060, United States

Location

Northwest Cancer Specialists

Vancouver, Washington, 98686, United States

Location

One Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

COT - Centro Oncologico do Triangulo

Uberlândia, Minas Gerais, 38408-150, Brazil

Location

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

Hospital de Clínicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul, Brazil

Location

Clínica de Oncologia Reichow

Blumenau, Santa Catarina, 89010-340, Brazil

Location

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, 01246-000, Brazil

Location

Oncoclinicas Rio de Janeiro S.A.

Rio de Janeiro, 22250-905, Brazil

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Centro de Estudios Clínicos SAGA

Santiago, Chile

Location

RedSalud Vitacura

Santiago, Chile

Location

Clinica De La Costa

Barranquilla, 080020, Colombia

Location

Hospital Universitario San Ignacio

Bogotá, 000472, Colombia

Location

Instituto Cancerología Medellin

Medellín, 050024, Colombia

Location

Clinica CIMCA

San José, 10103, Costa Rica

Location

ICIMED Instituto de Investigación en Ciencias Médicas

San José, 10108, Costa Rica

Location

Centre Leon Berard

Lyon, 69008, France

Location

Hia Sainte Anne

Toulon, 83041, France

Location

Klinikum rechts der Isar der TU Muenchen

München, 81675, Germany

Location

Asklepios Klinik Gauting

München-Gauting, 82131, Germany

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Medanta -The Medicity

Gurgaon, Haryana, India

Location

Rambam Medical Center

Haifa, 3109601, Israel

Location

Azienda Ospedaliera San Camillo Forlanini

Rome, Lazio, 00152, Italy

Location

Aichi Cancer Center Hospital

Aichi, 464-8681, Japan

Location

Kobe City Medical Center General Hospital

Hyōgo, 650-0047, Japan

Location

National Hospital Organization Himeji Medical Center

Hyōgo, 670-8520, Japan

Location

Kagoshima University Hospital

Kagoshima, 890-8520, Japan

Location

Kindai University Hospital

Ōsaka-sayama, 589-8511, Japan

Location

Shizuoka Cancer Center

Shizuoka, 411-8777, Japan

Location

Komagome Hospital

Tokyo, 113-8677, Japan

Location

The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

Location

Tottori University Hospital

Tottori, 683-8504, Japan

Location

Clinstile S.A de C.V.

Mexico City, Mexico CITY (federal District), 06700, Mexico

Location

Centro de Investigación Oncologica Galerias

Aguascalientes, 20124, Mexico

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

Auckland City Hospital, Cancer and Blood Research

Auckland, 1023, New Zealand

Location

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

Wroc?aw, 53-439, Poland

Location

University Clinical Centre of Serbia

Belgrade, 11030, Serbia

Location

Hospital Medical Center Bezanijska kosa

Belgrade, 11080, Serbia

Location

Institute for pulmonary diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

Univ Clinical Center Kragujevac

Kragujevac, 552302, Serbia

Location

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Pusan National University Yangsan Hospital

Gyeongsangnam-do, 50612, South Korea

Location

Chonnam National University Hwasun Hospital

Jeollanam-do, 58128, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, 13605, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

National Cheng Kung Univ Hosp

Tainan, 00704, Taiwan

Location

National Taiwan Uni Hospital

Taipei, 10041, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Taipei Municipal Wan Fang Hospital

Taipei, 119, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan District, 333, Taiwan

Location

Taichung Veterans General Hospital

Xitun Dist., 40705, Taiwan

Location

National Cancer Institute

Bangkok, 10400, Thailand

Location

Rajavithi Hospital

Bangkok, 10400, Thailand

Location

Siriraj Hospital

Bangkok, 10700, Thailand

Location

Oncology Unit, Faculty of Medicine, Vajira Hospital

Dusit, 10300, Thailand

Location

Srinagarind Hospital

Khon Kaen, 40002, Thailand

Location

Central Chest Institute of Thailand

Nonthaburi, 11000, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi

Ankara, 06280, Turkey (Türkiye)

Location

Gazi Uni Medical Faculty Hospital

Ankara, 06500, Turkey (Türkiye)

Location

Liv Hospital Ankara

Ankara, 06680, Turkey (Türkiye)

Location

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

Bakirkoy / Istanbul, 34147, Turkey (Türkiye)

Location

Dicle University Faculty of Medicine

Diyarbakır, 21280, Turkey (Türkiye)

Location

Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

Erzurum, 25240, Turkey (Türkiye)

Location

Medipol University Medical Faculty

Istanbul, 34214, Turkey (Türkiye)

Location

Marmara Uni Faculty of Medicine

Istanbul, 34890, Turkey (Türkiye)

Location

Medikal Park Samsun

Samsun, 55200, Turkey (Türkiye)

Location

Medical Park Seyhan Hospital

Seyhan, 01140, Turkey (Türkiye)

Location

Barts & London School of Med

London, EC1A 7BE, United Kingdom

Location

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 15, 2022
• Study Start: July 22, 2022
• Primary Completion: September 3, 2025
• Study Completion: September 3, 2025
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (2); IT (1); BR (6); US (5); CO (3); NZ (1); JP (9); AU (1); FR (2); IN (1); CL (2); SE (4); SG (1); HK (1); CA (1); KR (6); ES (1); TW (7); TU (10); GB (1); ME (2); PL (1); TH (7); NL (1); IL (1)