Screening Study for Participants With Malignant Tumors

  • Solid Tumors
Trial Status:

Recruiting

This trial runs in
Countries
  • Australia
  • Costa Rica
  • Hong Kong
  • Japan
  • South Korea
  • Thailand
  • United States
Trial Identifier:

NCT05419375 BX43361

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      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.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT05419375 , BX43361 Trial Identifier
      Screening platform Treatments
      Solid Tumors Condition
      Official Title

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

      Eligibility Criteria

      All Gender
      ≥18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      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
      Exclusion Criteria

      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

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