Non-Small Cell Lung CancerNCT02906852
Concordance of Inivata Liquid Biopsy With Standard of Care Tissue Testing
An observational study of Non-Small Cell Lung Cancer, run by Inivata at 35 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 264 participants
- Where
- 35 sitesUnited States
- Study dates
- 1 Aug 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Swedish Covenant Hospital
Chicago, Illinois, 60625
Boone Hospital Center
Columbia, Missouri, 65201
Thomas Spann Clinic Oncology
Corpus Christi, Texas, 78412
Northshore Hematology Oncology
East Setauket, New York, 11733
Providence Regional Medical Center
Everett, Washington, 98201
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
The West Clinic
Germantown, Tennessee, 38138
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
East Carolina University
Greenville, North Carolina, 27834
Henry Ford Allegiance Health
Jackson, Michigan, 49201
Jackson Oncology Associates, PLLC
Jackson, Mississippi, 39202
Tennessee Cancer Specialists
Knoxville, Tennessee, 37909
Norton Healthcare Inc
Louisville, Kentucky, 40202
Trinity Cancer Center
Minot, North Dakota, 58701
Levine Cancer Center
Mint Hill, North Carolina, 28227
Facey Medical Foundation
Mission Hills, California, 91345
Northern Westchester Hospital Association
Mount Kisco, New York, 10549
Christiana Care Health Services Inc
Newark, Delaware, 19713
Eastern CT Hematology Oncology
Norwich, Connecticut, 06360
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Mid-Florida Hematology and Oncology Centers
Orange City, Florida, 32763
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28374
Berkshire Hematology Oncology Services
Pittsfield, Massachusetts, 01201
Providence Health and Services
Portland, Oregon, 97213
Virginia Cancer Institute
Richmond, Virginia, 23226
Carolina Blood and Cancer Care
Rock Hill, South Carolina, 29732
Park Nicolett
Saint Louis Park, Minnesota, 55426
University of Washington (Swedish General)
Seattle, Washington, 98104
Christus Cancer Treatment Center
Shreveport, Louisiana, 71105
Edward M Kaplan, MD & Associates
Skokie, Illinois, 60076
Washington University (St. Louis)
St Louis, Missouri, 63110
Northwest Medical Specialties
Tacoma, Washington, 98405
Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
Hope Cancer Center of East Texas (Tyler Hem Onc)
Tyler, Texas, 75701
About this study
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.
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.
Read the 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.
- Conditions
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance in the detection of molecular abnormalities using Inivata's liquid biopsy panel with detection using standard of care tissue biopsy analysis
Measured: 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
Measured: 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
Measured: 1 year
Progression free survival (PFS) rate over 6 months
Measured: 1 year
Overall survival (OS) rate over 6 months
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 May 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inivata
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vector Oncology
- Responsible party
- Sponsor
- Investigators
- Ramaswamy Govindan, MD, Principal investigator, Washington University School of MedicineEdward Kim, MD, Principal investigator, Atrium Health Levine Cancer InstituteClive Morris, MD, Study director, Inivata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906852
- Sponsor's protocol ID
- INI001
- Status last verified
- May 2019
- First submitted
- 2 Sep 2016
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02906852
- Acronym / sponsor ID
- INI001
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- InivataIndustry (pharma, biotech, devices)
- Collaborators
- Vector Oncology
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concordance in the detection of molecular abnormalities using Inivata's liquid biopsy panel with detection using standard of care tissue biopsy analysis
Time frame: 1 year
4 secondary outcomes
Detection: sensitivity and specificity of molecular abnormalities using Inivata liquid biopsy panel relative to standard of care tissue biopsy analysis
Time frame: 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
Time frame: 1 year
Progression free survival (PFS) rate over 6 months
Time frame: 1 year
Overall survival (OS) rate over 6 months
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramaswamy Govindan, MD principal investigator
Washington University School of Medicine
Edward Kim, MD principal investigator
Atrium Health Levine Cancer Institute
Clive Morris, MD study director
Inivata
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Inivata at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance in the detection of molecular abnormalities using Inivata's liquid biopsy panel with detection using standard of care tissue biopsy analysis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.