Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT06934343

Conditions

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06934343

Start date

Sep 1, 2024

Status verified date

Apr, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

144400 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: From the initiation of first-line therapy to death or the last follow-up, whichever occurs first, up to 10 years. ]

Central Contacts and Locations

Locations

Huntsman Cancer Institute at the University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Principal Investigator:

Jincheng Shen, Ph.D.

More Information

Sponsor

University of Utah

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-05-04.