Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing

NCT02906852 | Completed

• 1 other identifier: INI001
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 35

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.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Detection: sensitivity and specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis

  1 year

• 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

• Progression free survival (PFS) rate over 6 months

  1 year

• Overall survival (OS) rate over 6 months

  1 year

Other Outcomes (1)

• Relationship of clinical response to therapy with mutation allele frequency (MAF) cutoff in Inivata liquid biopsy assay

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inivata: lead
• Vector Oncology: collaborator

Study Sites (35)

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Eastern CT Hematology Oncology

Norwich, Connecticut, 06360, United States

Location

Christiana Care Health Services Inc

Newark, Delaware, 19713, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

Mid-Florida Hematology and Oncology Centers

Orange City, Florida, 32763, United States

Location

Swedish Covenant Hospital

Chicago, Illinois, 60625, United States

Location

Edward M Kaplan, MD & Associates

Skokie, Illinois, 60076, United States

Location

Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Norton Healthcare Inc

Louisville, Kentucky, 40202, United States

Location

Christus Cancer Treatment Center

Shreveport, Louisiana, 71105, United States

Location

Berkshire Hematology Oncology Services

Pittsfield, Massachusetts, 01201, United States

Location

Henry Ford Allegiance Health

Jackson, Michigan, 49201, United States

Location

Park Nicolett

Saint Louis Park, Minnesota, 55426, United States

Location

Jackson Oncology Associates, PLLC

Jackson, Mississippi, 39202, United States

Location

Boone Hospital Center

Columbia, Missouri, 65201, United States

Location

Washington University (St. Louis)

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Northshore Hematology Oncology

East Setauket, New York, 11733, United States

Location

Northern Westchester Hospital Association

Mount Kisco, New York, 10549, United States

Location

East Carolina University

Greenville, North Carolina, 27834, United States

Location

Levine Cancer Center

Mint Hill, North Carolina, 28227, United States

Location

Pinehurst Medical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Trinity Cancer Center

Minot, North Dakota, 58701, United States

Location

Providence Health and Services

Portland, Oregon, 97213, United States

Location

Gettysburg Cancer Center

Gettysburg, Pennsylvania, 17325, United States

Location

Carolina Blood and Cancer Care

Rock Hill, South Carolina, 29732, United States

Location

The West Clinic

Germantown, Tennessee, 38138, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37909, United States

Location

Thomas Spann Clinic Oncology

Corpus Christi, Texas, 78412, United States

Location

Hope Cancer Center of East Texas (Tyler Hem Onc)

Tyler, Texas, 75701, United States

Location

Virginia Cancer Institute

Richmond, Virginia, 23226, United States

Location

Providence Regional Medical Center

Everett, Washington, 98201, United States

Location

University of Washington (Swedish General)

Seattle, Washington, 98104, United States

Location

Northwest Medical Specialties

Tacoma, Washington, 98405, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A 40ml blood sample will be taken, from which Plasma and ultimately DNA will be prepared.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ramaswamy Govindan, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Edward Kim, MD

  Atrium Health Levine Cancer Institute

  PRINCIPAL INVESTIGATOR

• Clive Morris, MD

  Inivata

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 20, 2016
• Study Start: August 1, 2016
• Primary Completion: May 31, 2018
• Study Completion: December 31, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)