Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing

Non-Small Cell Lung Cancer Clinical Trial

Official title:

Prospective Observational Study to Evaluate the Performance of Inivata Liquid Biopsy Analysis Compared With Standard Tissue Biopsy Analysis for Detection of Genomic Alterations in Patients With Advanced Non-small Cell Lung Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906852
• Other study ID #: INI001
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: May 2019
• Source: Inivata
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer.

Description:

The aim of this study is to evaluate the performance of Inivata liquid biopsy analysis compared with standard tissue biopsy analysis for detection of genomic alterations in patients with advanced lung cancer. Once selected for the study and with full informed consent, patients will have a blood draw to allow the detection of cancer-related genomic alterations that are detectable within the blood sample. These results will be compared to results obtained from genomic profiling via standard tissue biopsy taken as part of routine care to help determine whether such 'liquid biopsies' can be used to guide treatments in future patients. The results of the liquid biopsy will not be used to guide treatment decisions in study participants.

In addition there is data-collection of treatments received for non small cell lung cancer and the response to these treatments during the first 6 months post tissue and blood analysis, though no additional visits or procedures are required for the patient beyond the initial blood draw.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: December 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written, signed and dated informed consent to participate in the study must be given by the patient in accordance with 21 CFR Part 312, the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6, and applicable regulations, before completing any study-related procedures.

• Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC.

• Arms A and B: Patients intended to initiate first-line treatment according to standard guidelines. Note, a patient is eligible to receive sterotactic radiosurgery (no whole-brain radiotherapy). Arm C: Patients who are at a second-line treatment setting or greater may participate. Note, a patient may be included if they have metastatic brain lesions. Arms A, B, C: If enrolled in a treatment clinical trial, patients may also enroll in this study if all eligibility criteria are met.

• Arm A only: Patients intended to initiate first-line treatment according to standard guidelines who plan to have or have had a recent tumor tissue biopsy taken for molecular profiling as part of their standard of care.

• Patient must understand and be able, willing and likely to fully comply with all study procedures and restrictions.

Exclusion Criteria:

• Patients who have received any approved or experimental cancer therapy since their most recent NSCLC tissue biopsy (Arms A and B)

• Patients who have any other prior metastatic or current second primary cancer (Arms A and B)

• Patient who has a severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	Swedish Covenant Hospital	Chicago	Illinois
United States	Boone Hospital Center	Columbia	Missouri
United States	Thomas Spann Clinic Oncology	Corpus Christi	Texas
United States	Northshore Hematology Oncology	East Setauket	New York
United States	Providence Regional Medical Center	Everett	Washington
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	The West Clinic	Germantown	Tennessee
United States	Gettysburg Cancer Center	Gettysburg	Pennsylvania
United States	East Carolina University	Greenville	North Carolina
United States	Henry Ford Allegiance Health	Jackson	Michigan
United States	Jackson Oncology Associates, PLLC	Jackson	Mississippi
United States	Tennessee Cancer Specialists	Knoxville	Tennessee
United States	Norton Healthcare Inc	Louisville	Kentucky
United States	Trinity Cancer Center	Minot	North Dakota
United States	Levine Cancer Center	Mint Hill	North Carolina
United States	Facey Medical Foundation	Mission Hills	California
United States	Northern Westchester Hospital Association	Mount Kisco	New York
United States	Christiana Care Health Services Inc	Newark	Delaware
United States	Eastern CT Hematology Oncology	Norwich	Connecticut
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Mid-Florida Hematology and Oncology Centers	Orange City	Florida
United States	Pinehurst Medical Clinic	Pinehurst	North Carolina
United States	Berkshire Hematology Oncology Services	Pittsfield	Massachusetts
United States	Providence Health and Services	Portland	Oregon
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Carolina Blood and Cancer Care	Rock Hill	South Carolina
United States	Washington University (St. Louis)	Saint Louis	Missouri
United States	Park Nicolett	Saint Louis Park	Minnesota
United States	University of Washington (Swedish General)	Seattle	Washington
United States	Christus Cancer Treatment Center	Shreveport	Louisiana
United States	Edward M Kaplan, MD & Associates	Skokie	Illinois
United States	Northwest Medical Specialties	Tacoma	Washington
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	Hope Cancer Center of East Texas (Tyler Hem Onc)	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Inivata	Vector Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship of clinical response to therapy with mutation allele frequency (MAF) cutoff in Inivata liquid biopsy assay		1 year
Primary	Concordance in the detection of molecular abnormalities using Inivata's liquid biopsy panel with detection using standard of care tissue biopsy analysis		1 year
Secondary	Detection: sensitivity and specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis		1 year
Secondary	Proportion of NSCLC patients eligible for targeted therapy based on liquid biopsy analysis as an evaluation of feasibility molecular stratification, compared to standard of care alone		1 year
Secondary	Progression free survival (PFS) rate over 6 months		1 year
Secondary	Overall survival (OS) rate over 6 months		1 year