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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04474613
• Other study ID #: CASE1520
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 27, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: August 1, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Diagnostic Test:
• Liquid biopsy
Liquid biopsy done on a blood draw, taking approximately 7 days

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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