Status:

RECRUITING

Machine Learning Approaches to Personalized Therapy for Advanced Non-small Cell Lung Cancer With Real-World Data

Lead Sponsor:

University of Utah

Collaborating Sponsors:

Patient-Centered Outcomes Research Institute

Conditions:

Non-small Cell Lung Cancer

Eligibility:

All Genders

Brief Summary

This research will leverage machine learning (ML) and causal inference techniques applied to real-world data (RWD) to generate evidence that personalizes treatment strategies for patients with advance...

Detailed Description

The proposed research will enhance patient-centered outcomes research (PCOR) and comparative effectiveness research (CER) methodologies by addressing two key challenges: (1) appropriate handling of mi...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Subjects must meet all of the following eligibility criteria:
  • Diagnosed with advanced NSCLC between January 1, 2011, and June 30, 2024.
  • Follow-up available until December 31, 2024, with a minimum potential follow-up period of at least six months.
  • Exclusion Criteria
  • Subjects meeting any of the following criteria at baseline will be excluded:
  • Fewer than one day of follow-up post-initiation of first-line (1L) therapy.
  • Presence of a targetable mutation, including ALK, BRAF, EGFR, KRAS, or ROS1.
  • PD-L1 expression \<50% at baseline (restricted to patients with PD-L1 ≥50%).
  • First-line treatment limited to immunotherapy or chemoimmunotherapy (excluding other treatment regimens).
  • Patients receiving second-line (2L) treatment, including those enrolled in a clinical study.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    March 1 2026

    Estimated Enrollment :

    144400 Patients enrolled

    Trial Details

    Trial ID

    NCT06934343

    Start Date

    September 1 2024

    End Date

    March 1 2026

    Last Update

    April 18 2025

    Active Locations (1)

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    1

    Huntsman Cancer Institute at the University of Utah

    Salt Lake City, Utah, United States, 84112