Screening Study for Participants With Malignant Tumors

  • Cancer
  • Solid Tumors
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:

Recruiting

This study runs in
Countries
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Colombia
  • Costa Rica
  • France
  • Germany
  • Hong Kong
  • India
  • Israel
  • Italy
  • Japan
  • Korea, Republic of
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Serbia
  • Singapore
  • Spain
  • Taiwan
  • Thailand
  • Turkey
  • United Kingdom
  • United States
Study Identifier:

NCT05419375 BX43361

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Study 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 Study 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

      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
      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

      For the latest version of this information please go to www.forpatients.roche.com

       

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