Clinical trial NCT02906852: Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Inivata
Sponsor class: INDUSTRY
Collaborators: name: Vector Oncology
First posted: 2016-09-20
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients aged 18 years and over diagnosed with stage IIIb/IV non-squamous NSCLC, who are intended to initiate first-line treatment according to standard guidelines, or having recently progressed on first-line EGFR or ALK directed therapy and being considered for further therapy.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Concordance in the detection of molecular abnormalities using Inivata's liquid biopsy panel with detection using standard of care tissue biopsy analysis
timeFrame: 1 year
Secondary outcomes:
measure: Detection: sensitivity and specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Progression free survival (PFS) rate over 6 months
timeFrame: 1 year
measure: Overall survival (OS) rate over 6 months
timeFrame: 1 year
Other outcomes:
measure: Relationship of clinical response to therapy with mutation allele frequency (MAF) cutoff in Inivata liquid biopsy assay
timeFrame: 1 year
Locations:
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Norwich
country: United States
facility: Eastern CT Hematology Oncology
state: Connecticut
city: Newark
country: United States
facility: Christiana Care Health Services Inc
state: Delaware
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Orange City
country: United States
facility: Mid-Florida Hematology and Oncology Centers
state: Florida
city: Chicago
country: United States
facility: Swedish Covenant Hospital
state: Illinois
city: Skokie
country: United States
facility: Edward M Kaplan, MD & Associates
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Louisville
country: United States
facility: Norton Healthcare Inc
state: Kentucky
city: Shreveport
country: United States
facility: Christus Cancer Treatment Center
state: Louisiana
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology Services
state: Massachusetts
city: Jackson
country: United States
facility: Henry Ford Allegiance Health
state: Michigan
city: Saint Louis Park
country: United States
facility: Park Nicolett
state: Minnesota
city: Jackson
country: United States
facility: Jackson Oncology Associates, PLLC
state: Mississippi
city: Columbia
country: United States
facility: Boone Hospital Center
state: Missouri
city: Saint Louis
country: United States
facility: Washington University (St. Louis)
state: Missouri
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: East Setauket
country: United States
facility: Northshore Hematology Oncology
state: New York
city: Mount Kisco
country: United States
facility: Northern Westchester Hospital Association
state: New York
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
city: Mint Hill
country: United States
facility: Levine Cancer Center
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic
state: North Carolina
city: Minot
country: United States
facility: Trinity Cancer Center
state: North Dakota
city: Portland
country: United States
facility: Providence Health and Services
state: Oregon
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care
state: South Carolina
city: Germantown
country: United States
facility: The West Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Tennessee Cancer Specialists
state: Tennessee
city: Corpus Christi
country: United States
facility: Thomas Spann Clinic Oncology
state: Texas
city: Tyler
country: United States
facility: Hope Cancer Center of East Texas (Tyler Hem Onc)
state: Texas
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington (Swedish General)
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
Study officials:
affiliation: Washington University School of Medicine
name: Ramaswamy Govindan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atrium Health Levine Cancer Institute
name: Edward Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inivata
name: Clive Morris, MD
role: STUDY_DIRECTOR
References: