Screening Study for Participants With Malignant Tumors

Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Other: Screening platform

• Study Type: Interventional
• Enrollment (Actual): 470
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • One Clinical Research
• Brazil
  • Rio de Janeiro, Brazil, 22250-905
    • Oncoclinicas Rio de Janeiro S.A.
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38408-150
      • COT - Centro Oncologico do Triangulo
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
      • Santa Casa de Misericordia de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Hospital de Clinicas de Porto Alegre X
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89010-340
      • Clínica de Oncologia Reichow
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01246-000
      • Instituto do Cancer do Estado de Sao Paulo - ICESP
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
• Chile
  • Santiago, Chile
    • Centro de estudios clinicos SAGA
  • Santiago, Chile
    • RedSalud Vitacura
• Colombia
  • Barranquilla, Colombia, 080020
    • Clinica De La Costa
  • Bogotá, Colombia, 000472
    • Hospital Universitario San Ignacio
  • Medellín, Colombia, 050024
    • Instituto Cancerología Medellin
• Costa Rica
  • San José, Costa Rica, 10103
    • Clinica CIMCA
  • San José, Costa Rica, 10108
    • ICIMED Instituto de Investigación en Ciencias Médicas
• France
  • Lyon, France, 69008
    • Centre Leon Berard
  • Toulon, France, 83041
    • HIA Sainte Anne
• Germany
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU Muenchen
  • München-Gauting, Germany, 82131
    • Asklepios Klinik Gauting
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
• India
  • Haryana
    • Gurgaon, Haryana, India
      • Medanta -The Medicity
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center
• Italy
  • Lazio
    • Rome, Lazio, Italy, 00152
      • Azienda Ospedaliera San Camillo Forlanini
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center Hospital
  • Hyōgo, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Hyōgo, Japan, 670-8520
    • National Hospital Organization Himeji Medical Center
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Shizuoka, Japan, 411-8777
    • Shizuoka Cancer Center
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital Of JFCR
  • Tokyo, Japan, 113-8677
    • Komagome Hospital
  • Tottori, Japan, 683-8504
    • Tottori University Hospital
  • Ōsaka-sayama, Japan, 589-8511
    • Kindai University Hospital
• Mexico
  • Aguascalientes, Mexico, 20124
    • Centro de Investigación Oncologica Galerias
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 06700
      • Clinstile S.A de C.V.
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
• New Zealand
  • Auckland, New Zealand, 1023
    • Auckland City Hospital, Cancer and Blood Research
• Poland
  • Wroc?aw, Poland, 53-439
    • Dolno?l?skie Centrum Chorób P?uc we Wroc?awiu
• Serbia
  • Belgrade, Serbia, 11030
    • University Clinical Centre of Serbia
  • Belgrade, Serbia, 11080
    • Hospital Medical Center Bezanijska kosa
  • Kamenitz, Serbia, 21204
    • Institute for pulmonary diseases of Vojvodina
  • Kragujevac, Serbia, 552302
    • Univ Clinical Center Kragujevac
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
• South Korea
  • Gyeongsangnam-do, South Korea, 50612
    • Pusan National University Yangsan Hospital
  • Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seongnam-si, South Korea, 13605
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
• Spain
  • Málaga, Spain, 29010
    • Hospital Regional Universitario Carlos Haya
• Taiwan
  • Tainan, Taiwan, 00704
    • National Cheng Kung Univ Hosp
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 110
    • Taipei Medical University Hospital
  • Taipei, Taiwan, 10041
    • National Taiwan Uni Hospital
  • Taipei, Taiwan, 119
    • Taipei Municipal Wan Fang Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Memorial Hospital - Linkou
  • Xitun Dist., Taiwan, 40705
    • Taichung Veterans General Hospital
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital
  • Bangkok, Thailand, 10400
    • National Cancer Institute
  • Dusit, Thailand, 10300
    • Oncology Unit, Faculty of Medicine, Vajira Hospital
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital
  • Nonthaburi, Thailand, 11000
    • Central Chest Institute of Thailand
  • Songkhla, Thailand, 90110
    • Songklanagarind Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06500
    • Gazi Uni Medical Faculty Hospital
  • Ankara, Turkey (Türkiye), 06680
    • Liv Hospital Ankara
  • Ankara, Turkey (Türkiye), 06280
    • Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
  • Bakirkoy / Istanbul, Turkey (Türkiye), 34147
    • Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
  • Diyarbakır, Turkey (Türkiye), 21280
    • Dicle University Faculty of Medicine
  • Erzurum, Turkey (Türkiye), 25240
    • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
  • Istanbul, Turkey (Türkiye), 34214
    • Medipol University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34890
    • Marmara Uni Faculty of Medicine
  • Samsun, Turkey (Türkiye), 55200
    • Medikal Park Samsun
  • Seyhan, Turkey (Türkiye), 01140
    • Medical Park Seyhan Hospital
• United Kingdom
  • London, United Kingdom, EC1A 7BE
    • Barts & London School of Med
• United States
  • Tennessee
    • Knoxville, Tennessee, United States, 37916-2305
      • Thompson Cancer Survival Center
  • Texas
    • Austin, Texas, United States, 78745
      • Texas Oncology, P.A.
    • Tyler, Texas, United States, 75702
      • Texas Oncology- Northeast Texas
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Oncology & Hematology Associates of Southwest Virginia, Inc
  • Washington
    • Vancouver, Washington, United States, 98686
      • Northwest Cancer Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Non-Small Cell Lung Cancer (NSCLC); Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study.	Other: Screening platform; The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2022
• Primary Completion (Actual): September 3, 2025
• Study Completion (Actual): September 3, 2025

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BX43361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No