Screening Study for Participants With Malignant Tumors

February 2, 2026 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
470

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of participants with evaluable biomarker results
Time Frame: Up to 10 years
Up to 10 years
Proportion of participants eligible for a linked Roche clinical trial
Time Frame: Up to 10 years
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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