Liquid Biopsy to Reduce Time to Treatment for Advanced Nonsquamous NSCLC Diagnosed at Outside Sites

Case Comprehensive Cancer Center26 enrolled

Overview

The purpose of this study is to determine if liquid biopsies will reduce time to begin treatment in participants with non-small cell lung cancer (NSCLC). A liquid biopsy is a test done on a sample of blood to look for cancer cells.

Referred patients with newly diagnosed NSCLC who have not had genetic testing for targetable mutations will be considered for this study. The primary objective of this prospective study is to examine if using liquid biopsy can reduce time to treatment (TTT) in external participants with NSCLC. Secondary objectives examined will include time to actionable genetic testing results (ctDNA or tissue), rate of actionable biomarker discovery, and rate of appropriate guideline-directed therapy based upon testing results. A liquid biopsy is a test done on a sample of blood to look for cancer cells. A traditional biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. A liquid biopsy takes 7 days which significantly shortens the TTT for those diagnosed with NSCLC. By studying this, doctors may be better able to determine if this will be beneficial and result in less time taken to treat cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Cancer

Interventions

Liquid biopsyDIAGNOSTIC_TEST

Liquid biopsy done on a blood draw, taking approximately 7 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants with newly diagnosed, advanced nonsquamous NSCLC referred to the Cleveland Clinic Taussig Cancer Center from outside centers without prior testing results available for targetable genetic alterations * Plan to receive systemic therapy at the Cleveland Clinic, OR plan to receive systemic therapy at an outside site while maintaining either intermittent follow up at Cleveland Clinic or with electronic health record access through Care Everywhere. Exclusion Criteria: * Prior therapy for this diagnosis of NSCLC * Prior adequate molecular testing done for the current diagnosis of NSCLC

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

TTT measured in days

TTT measured in days - TTT will be summarized using mean, SD, and range. One sample t-test will be used to compare observed TTT against the null (30 days).

Time frame: An average of 30 days

Secondary Outcomes

Time to actionable genetic testing results

Time to actionable genetic testing results (ctDNA or tissue). Negative results with ctDNA testing will still require tissue confirmation, while positive results will be considered actionable without further testing.

Time frame: An average of 30 days

Rate of actionable biomarker discovery

Rate of actionable biomarker discovery, defined as the percentage of tested patients who have a detected genetic marker that is associated with either 1) an FDA-approved targeted treatment or 2) a targeted treatment available through a clinical trial.

Time frame: An average of 30 days

Rate of appropriate guideline-directed therapy based upon testing results

Time frame: An average of 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.