Status:

RECRUITING

PROGRESS: Precision Oncology Using Genomic Reflexive Evaluations for Study Selection and Survival

Lead Sponsor:

UNC Lineberger Comprehensive Cancer Center

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Solid Tumor Malignancies

Metastatic Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This is a hybrid decentralized, single-arm, interventional study designed to evaluate the impact of precision medicine navigation and reflexive expert review of next-generation sequencing (NGS) for pa...

Detailed Description

Despite data supporting a survival benefit in many cancers, rates of NGS testing and subsequent GIT are reported to be low in real-world data sets. Rates of multigene panel-based testing and targeted ...

Eligibility Criteria

Inclusion

  • In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
  • Inclusion Criteria
  • Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information.
  • Subjects are willing and able to comply with study procedures based on the judgment of the investigator.
  • Age ≥ 18 years at the time of consent.
  • ECOG or Karnofsky Performance Status of 0-2.
  • Documented Stage IV solid tumor malignancy: NSCLC, CRC, Breast or Bladder Cancer
  • The treating provider deems Next Generation Sequencing (NGS) testing appropriate and plans to consider results in either first- or second-line therapy in the metastatic setting
  • A genomic tumor test has not been ordered or has been ordered but not resulted.
  • Exclusion Criteria:
  • • Subjects with an active concurrent malignancy.

Exclusion

    Key Trial Info

    Start Date :

    June 27 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    June 1 2028

    Estimated Enrollment :

    500 Patients enrolled

    Trial Details

    Trial ID

    NCT06896162

    Start Date

    June 27 2025

    End Date

    June 1 2028

    Last Update

    July 11 2025

    Active Locations (1)

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    Lineberger Comprehensive Cancer Center, University of North Carolina

    Chapel Hill, North Carolina, United States, 27599