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

Use of Liquid Biopsy to Reduce Time to Treatment for Patients With Advanced Nonsquamous Non-small Cell Lung Cancer Diagnosed at Outside Sites

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Diagnostic test: Liquid biopsy

Detailed Description

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
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44915
      • Cleveland Clinic, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liquid biopsy; A liquid biopsy is a test will be done on a sample of blood to look for cancer cells	Diagnostic test: Liquid biopsy; Liquid biopsy done on a blood draw, taking approximately 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	An average of 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	An average of 30 days
Rate of appropriate guideline-directed therapy based upon testing results	Rate of appropriate guideline-directed therapy based upon testing results	An average of 30 days

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Nathan Pennell, MD, PhD, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: CASE1520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlies the publication
• IPD Sharing Time Frame: Shortly after completion of the study which is to take approximately one year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No