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Trial record 1 of 1 for:    BX43361
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Screening Study for Participants With Malignant Tumors

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ClinicalTrials.gov Identifier: NCT05419375
Recruitment Status : Recruiting
First Posted : June 15, 2022
Last Update Posted : March 30, 2023
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Other: Screening platform Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Master Screening Study to Determine Biomarker Status and Potential Trial Eligibility for Patients With Malignant Tumors
Actual Study Start Date : July 22, 2022
Estimated Primary Completion Date : August 21, 2032
Estimated Study Completion Date : December 22, 2032

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Proportion of participants with evaluable biomarker results [ Time Frame: Up to 10 years ]
  2. Proportion of participants eligible for a linked Roche clinical trial [ Time Frame: Up to 10 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05419375

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Contact: Reference Study ID Number: BX43361 https://forpatients.roche.com 1-888-662-6728 global-roche-genentech-trials@gene.com

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Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT05419375    
Other Study ID Numbers: BX43361
First Posted: June 15, 2022    Key Record Dates
Last Update Posted: March 30, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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