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

NCT06934343 | Recruiting

• 2 other identifiers: HCI183476ME-2023C2-33957
• Study Type: observational
• Target: 144,400
• Locations: 1 country
• Sites: 1

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 advanced non-small cell lung cancer (aNSCLC). Rather than influencing regulatory decisions or clinical guidelines, the goal of this trial is to refine treatment selection among existing therapeutic options, ensuring that care is tailored to individual patient characteristics. Additionally, by generating real-world evidence, these findings will inform the design and implementation of future clinical trials. Importantly, the methodological advancements will establish a pipeline that extends beyond aNSCLC, facilitating the identification of optimal dynamic treatment regimes (DTRs) for other complex diseases.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Mortality is the primary concern in aNSCLC care. This study will track survival from the initiation of first-line therapy to death or the last follow-up, whichever occurs first. OS will be censored at the last recorded date in the electronic health records.

  From the initiation of first-line therapy to death or the last follow-up, whichever occurs first, up to 10 years.

Secondary Outcomes (4)

• Quality-Adjusted Life Years (QALYs)

  From the initiation of first-line therapy to death or the last follow-up, whichever occurs first, up to 2 years.

• Time to second progression or death (PFS2)

  From the initiation of first-line therapy to second disease progression, death, or the last follow-up, whichever occurs first, up to 10 years.

• National Cancer Institute (NCI) Patient-Reported Outcomes Measurement Information System-Cancer (PROMIS-Ca)

  From the initiation of first-line therapy to worsening or the last follow-up, whichever occurs first, up to 10 years.

• Edmonton Symptom Assessment System (ESAS) Outcomes

  From the initiation of first-line therapy to worsening or the last follow-up, whichever occurs first, up to 10 years.

Study Arms (4)

Flatiron database

The current study will utilize data from national EHR databases (Flatiron and CancerLinQ) and existing cohort data (HCI and MCC). Only de-identified data will be used, and no patients will be contacted during the study.

CancerLinQ database

The current study will utilize data from national EHR databases (Flatiron and CancerLinQ) and existing cohort data (HCI and MCC). Only de-identified data will be used, and no patients will be contacted during the study.

Huntsman Cancer Institute (HCI) Cohort

The current study will utilize data from national EHR databases (Flatiron and CancerLinQ) and existing cohort data (HCI and MCC). Only de-identified data will be used, and no patients will be contacted during the study.

Moffitt Cancer Center (MCC) Cohort

The current study will utilize data from national EHR databases (Flatiron and CancerLinQ) and existing cohort data (HCI and MCC). Only de-identified data will be used, and no patients will be contacted during the study.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The primary research focus is on non-small cell lung cancer (NSCLC), which accounts for 85% of all lung cancer cases and remains a leading cause of cancer mortality in the United States. This study will use de-identified EHR data from two large nationwide databases - Flatiron and CancerLinQ - as well as de-identified data from Huntsman Cancer Institute (HCI) and Moffitt Cancer Center (MCC) to gain insights into personalized aNSCLC care.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: April 18, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)