Solid TumorsPhase 2NCT05419375
Screening Study for Participants With Malignant Tumors
A Phase 2 study testing Screening platform in people with Solid Tumors, run by Hoffmann-La Roche at 79 sites in 26 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Screening platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 79 sitesin 26 countries
- Study dates
- 22 Jul 2022to 3 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
None listed.
Trial locations and contacts
79 sites in 26 countries.
79 sites in 26 countries
Turkey (Türkiye)10 sites
Ataturk Sanatoryum Egitim Ve Arastirma Hastanesi
Ankara, 06280
Gazi Uni Medical Faculty Hospital
Ankara, 06500
Liv Hospital Ankara
Ankara, 06680
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, 34147
Dicle University Faculty of Medicine
Diyarbakır, 21280
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department
Erzurum, 25240
Medipol University Medical Faculty
Istanbul, 34214
Marmara Uni Faculty of Medicine
Istanbul, 34890
Medikal Park Samsun
Samsun, 55200
Medical Park Seyhan Hospital
Seyhan, 01140
Japan9 sites
Aichi Cancer Center Hospital
Aichi, 464-8681
Kobe City Medical Center General Hospital
Hyōgo, 650-0047
National Hospital Organization Himeji Medical Center
Hyōgo, 670-8520
Kagoshima University Hospital
Kagoshima, 890-8520
Kindai University Hospital
Ōsaka-sayama, 589-8511
Shizuoka Cancer Center
Shizuoka, 411-8777
Komagome Hospital
Tokyo, 113-8677
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550
Tottori University Hospital
Tottori, 683-8504
Taiwan7 sites
National Cheng Kung Univ Hosp
Tainan, 00704
National Taiwan Uni Hospital
Taipei, 10041
Taipei Medical University Hospital
Taipei, 110
Taipei Veterans General Hospital
Taipei, 11217
Taipei Municipal Wan Fang Hospital
Taipei, 119
Chang Gung Memorial Hospital - Linkou
Taoyuan, 333
Taichung Veterans General Hospital
Xitun Dist., 40705
Thailand7 sites
National Cancer Institute
Bangkok, 10400
Rajavithi Hospital
Bangkok, 10400
Siriraj Hospital
Bangkok, 10700
Oncology Unit, Faculty of Medicine, Vajira Hospital
Dusit, 10300
Srinagarind Hospital
Khon Kaen, 40002
Central Chest Institute of Thailand
Nonthaburi, 11000
Songklanagarind Hospital
Songkhla, 90110
Brazil6 sites
Clínica de Oncologia Reichow
Blumenau, Santa Catarina, 89010-340
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
Hospital de Clínicas de Porto Alegre X
Porto Alegre, Rio Grande do Sul
Oncoclinicas Rio de Janeiro S.A.
Rio de Janeiro, 22250-905
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
COT - Centro Oncologico do Triangulo
Uberlândia, Minas Gerais, 38408-150
South Korea6 sites
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Seoul National University Bundang Hospital
Seongnam-si, 13605
Kangbuk Samsung Hospital
Seoul, 03181
Asan Medical Center
Seoul, 05505
Korea University Guro Hospital
Seoul, 08308
United States5 sites
Texas Oncology, P.A.
Austin, Texas, 78745
Oncology & Hematology Associates of Southwest Virginia, Inc
Blacksburg, Virginia, 24060
Thompson Cancer Survival Center
Knoxville, Tennessee, 37916-2305
Texas Oncology- Northeast Texas
Tyler, Texas, 75702
Northwest Cancer Specialists
Vancouver, Washington, 98686
Serbia4 sites
University Clinical Centre of Serbia
Belgrade, 11030
Hospital Medical Center Bezanijska kosa
Belgrade, 11080
Institute for pulmonary diseases of Vojvodina
Kamenitz, 21204
Univ Clinical Center Kragujevac
Kragujevac, 552302
Colombia3 sites
Clinica De La Costa
Barranquilla, 080020
Hospital Universitario San Ignacio
Bogotá, 000472
Instituto Cancerología Medellin
Medellín, 050024
Chile2 sites
Centro de Estudios Clínicos SAGA
Santiago
RedSalud Vitacura
Santiago
Costa Rica2 sites
Clinica CIMCA
San José, 10103
ICIMED Instituto de Investigación en Ciencias Médicas
San José, 10108
Germany2 sites
Klinikum rechts der Isar der TU Muenchen
München, 81675
Asklepios Klinik Gauting
München-Gauting, 82131
Mexico2 sites
Centro de Investigación Oncologica Galerias
Aguascalientes, 20124
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), 06700
Netherlands1 site
Maastricht University Medical Center
Maastricht, 6229 HX
New Zealand1 site
Auckland City Hospital, Cancer and Blood Research
Auckland, 1023
About this study
Official title: 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.
- Conditions
- Solid Tumors
- Being tested
- Screening platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening platformOther
The screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing.
| Study group | Role | What they receive |
|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Other | Participants with NSCLC will be screened for biomarker eligibility for a linked Roche study. Receives: Other: Screening platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with evaluable biomarker results
Measured: Up to 10 years
Proportion of participants eligible for a linked Roche clinical trial
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start22 Jul 2022
- Primary completion3 Sep 2025
- Study completion3 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 470 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419375
- Sponsor's protocol ID
- BX43361
- Status last verified
- Feb 2026
- First submitted
- 13 Jun 2022
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors
- ClinicalTrials.gov ID
- NCT05419375
- Acronym / sponsor ID
- BX43361
- Conditions
- Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 3 Sep 2025 (actual)
- Study completion
- 3 Sep 2025 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Small Cell Lung Cancer (NSCLC) | Other | Other: Screening platformParticipants with NSCLC will be screened for biomarker eligibility for a linked Roche study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening platformThe screening platform will be used to determine biomarker eligibility for a linked Roche study based on tissue-based testing. | Other | Non-Small Cell Lung Cancer (NSCLC) |
Primary outcome
Proportion of participants with evaluable biomarker results
Time frame: Up to 10 years
Proportion of participants eligible for a linked Roche clinical trial
Time frame: Up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. 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
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RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
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SW-682 in Advanced Solid Tumors
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RecruitingPhase 1
Study to Evaluate CD8 PET Imaging as a Marker of Immune Response to Stereotactic Body Radiation Therapy (ELIXR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
79 sites in 26 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Screening platform in people with Solid Tumors, run by Hoffmann-La Roche at 79 sites in 26 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in Turkey (Türkiye), Japan, Taiwan, Thailand, Brazil and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with evaluable biomarker results (time frame: Up to 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.