Non Small Cell Lung CarcinomaNCT02762877
Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma in Non Small Cell Lung Cancer
An observational study of Non Small Cell Lung Carcinoma, run by Genomic Health®, Inc. at 22 sites in 7 countries.
Trial summary
A study to determine the concordance of key actionable genomic alterations as assessed in tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Carcinoma
- How many people
- 140 participants
- Where
- 22 sitesin 7 countries
- Study dates
- Apr 2016to 19 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Non small cell lung cancer patients
Who may be able to join
- Subjects must be 18 years or older.
- Patients with stage IV non squamous NSCLC who are either newly diagnosed or progressing on any treatment (progression defined as increasing tumor size or new metastatic lesions on clinical or imaging assessment).
- Patients with available tissue sample from a metastatic site or, if the patient presents with stage IV disease at diagnosis, from the primary tumor or a metastatic site. If a patient is progressing on EGFR targeted therapy (erlotinib, gefitinib, afatinib), tumor tissue sample is required only if available.
- No new systemic anti-tumor therapy administered in the interval between the tissue biopsy and collection of the blood sample. (interval not to exceed eight weeks). Local radiation therapy is permitted.
- Able and willing to read, understand and sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, or equivalent privacy law, where this is applicable.
Who cannot join
- Patients who are currently receiving therapy (targeted, immune- or chemotherapy) without sign of progression.
- Patients with squamous NSCLC.
- Patients with more than 8 weeks between collection of tumor specimen and collection of blood sample for analysis. (Not applicable for patients progressing on EGFR targeted therapy with no biopsy at progression)
- Patients changing EGFR therapy due to toxicity or preference without documented disease progression.
- Patients progressing on Osimertinib treatment.
- Patients with brain metastases only.
- Inability to comply with study and/or follow-up procedures.
- Unable or unwilling to provide written informed consent.
Trial locations and contacts
22 sites in 7 countries.
22 sites in 7 countries
United States9 sites
Essex Oncology of North Jersey
Belleville, New Jersey, 07109
Gabrail Cancer Center
Canton, Ohio, 44718
West Clinic
Germantown, Tennessee, 38138
Central Georgia Cancer Care
Macon, Georgia, 31201
Bon Secours Cancer Institute
Midlothian, Virginia, 23114
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Meridian Hospitals
Neptune City, New Jersey, 07753
MultiCare Health System
Tacoma, Washington, 98405
Cancer Care Associates d/b/a Torrance Memorial Physician Network
Torrance, California, 90277
Chile3 sites
Instituto Nacional del Torax
Santiago, 7500691
Fundación Arturo López Perez
Santiago, 7500836
Clinica Alemana de Santiago
Santiago, 7650551
France3 sites
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33000
Centre Jean Perrin
Clermont-Ferrand, Cedex 1, 63011
Hôpital Nord
Marseille, Cedex 20, 13915
Spain3 sites
Hospital Universitario Central Asturias
Oviedo, 33011
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital Clinico Universitario Lozano Blesa
Zaragoza, 50009
Japan2 sites
Tokyo Medical University Hospital
Tokyo, Shinjuku-ku, 160-0023
National Cancer Center
Tokyo, Tsukiji, Chuo-ku, 104-0045
United Kingdom1 site
Clatterbridge Cancer Center NHS Foundation Trust
Bebington, Wirral, CH63 4JK
About this study
Official title: A Study to Determine the Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma From Patients With Non Small Cell Lung Carcinoma (NSCLC)
A study to determine the concordance of key actionable genomic alterations as assessed in tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)
Read the detailed description
This is a prospective clinical study to characterize the concordance of key clinically relevant genomic alterations in tumor tissue (biopsy/excision/cytology) and liquid biopsy (blood) using the Genomic Health LBMP in patients with stage IV non squamous NSCLC, that are either newly diagnosed with metastatic disease or progressing on therapy (any line). Tissue biopsy and blood collection (liquid biopsy) should be less than eight weeks apart and with no new systemic antitumoral treatment given in the interval between the tissue biopsy and blood collection. Local assessment of tumor tissue samples will be performed at each participating institution as per their clinical standard of care practices and results from the local assessment of genomic alteration status will be used.
- Conditions
- Non Small Cell Lung Carcinoma
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Patients with non-squamous NSCLC either newly diagnosed or progressing on any therapy (except erlotinib, gefitinib, or afatinib) | |
| B | Patients with non-squamous NSCLC who are progressing on erlotinib, gefitinib, or afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance of Genomic Alterations in EGFR Detected in Plasma Versus Tumor Tissue in Stage IV Non Squamous NSCLC Patients Who Are Newly Diagnosed or Progressing on Treatment
Assess concordance of genomic alterations in EGFR detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne, or locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.
Measured: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
Secondary outcomes (2)
Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue.
Assess concordance of genomic alterations in ALK (EML4-ALK fusions) detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne OR locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.
Measured: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
Percentage of Participants With EGFR T790M Alterations in Plasma in Patients Progressing on EGFR Targeting Therapy (Erlotinib, Gefitinib, Afatinib).
Detection of EGFR T790M alterations in plasma using the OncotypeSEQ Liquid Select assay. Progression on EGFR targeting therapy (erlotinib, gefitinib, afatinib) assessed clinically or radiologically
Measured: Time between patient tumor tissue biopsy and and blood collection (blood collected after the patient progressed on EGFR targeted therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startApr 2016
- Primary completion1 Jul 2018
- Study completion19 Jun 2019
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CarcinomaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genomic Health®, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02762877
- Sponsor's protocol ID
- 14-009
- Status last verified
- Nov 2020
- First submitted
- 29 Apr 2016
- Last updated
- 17 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Concordance of Key Actionable Genomic Alterations as Assessed in Tumor Tissue and Plasma From Patients With Non Small Cell Lung Carcinoma (NSCLC)
- ClinicalTrials.gov ID
- NCT02762877
- Acronym / sponsor ID
- 14-009
- Conditions
- Non Small Cell Lung Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Genomic Health®, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 25 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to determine the concordance of key actionable genomic alterations as assessed in tumor tissue and plasma from patients with non small cell lung carcinoma (NSCLC)
Detailed description
This is a prospective clinical study to characterize the concordance of key clinically relevant genomic alterations in tumor tissue (biopsy/excision/cytology) and liquid biopsy (blood) using the Genomic Health LBMP in patients with stage IV non squamous NSCLC, that are either newly diagnosed with metastatic disease or progressing on therapy (any line). Tissue biopsy and blood collection (liquid biopsy) should be less than eight weeks apart and with no new systemic antitumoral treatment given in the interval between the tissue biopsy and blood collection. Local assessment of tumor tissue samples will be performed at each participating institution as per their clinical standard of care practices and results from the local assessment of genomic alteration status will be used.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Patients with non-squamous NSCLC either newly diagnosed or progressing on any therapy (except erlotinib, gefitinib, or afatinib) |
| B | – | –Patients with non-squamous NSCLC who are progressing on erlotinib, gefitinib, or afatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non small cell lung cancer patients
Key inclusion criteria (5 listed)
- Subjects must be 18 years or older.
- Patients with stage IV non squamous NSCLC who are either newly diagnosed or progressing on any treatment (progression defined as increasing tumor size or new metastatic lesions on clinical or imaging assessment).
- Patients with available tissue sample from a metastatic site or, if the patient presents with stage IV disease at diagnosis, from the primary tumor or a metastatic site. If a patient is progressing on EGFR targeted therapy (erlotinib, gefitinib, afatinib), tumor tissue sample is required only if available.
- No new systemic anti-tumor therapy administered in the interval between the tissue biopsy and collection of the blood sample. (interval not to exceed eight weeks). Local radiation therapy is permitted.
- Able and willing to read, understand and sign an informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, or equivalent privacy law, where this is applicable.
Key exclusion criteria (8 listed)
- Patients who are currently receiving therapy (targeted, immune- or chemotherapy) without sign of progression.
- Patients with squamous NSCLC.
- Patients with more than 8 weeks between collection of tumor specimen and collection of blood sample for analysis. (Not applicable for patients progressing on EGFR targeted therapy with no biopsy at progression)
- Patients changing EGFR therapy due to toxicity or preference without documented disease progression.
- Patients progressing on Osimertinib treatment.
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 of Genomic Alterations in EGFR Detected in Plasma Versus Tumor Tissue in Stage IV Non Squamous NSCLC Patients Who Are Newly Diagnosed or Progressing on Treatment
Time frame: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
Assess concordance of genomic alterations in EGFR detected in plasma (using the OncotypeSEQ Liquid Select assay) versus tumor tissue (assessed centrally using FoundationOne, or locally based on the patient's clinic) in stage IV non squamous NSCLC patients who are newly diagnosed or progressing on treatment.
2 secondary outcomes
Concordance of Genomic Alterations in ALK (EML4-ALK Fusions) Detected in Plasma Versus Tumor Tissue.
Time frame: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks
Percentage of Participants With EGFR T790M Alterations in Plasma in Patients Progressing on EGFR Targeting Therapy (Erlotinib, Gefitinib, Afatinib).
Time frame: Time between patient tumor tissue biopsy and and blood collection (blood collected after the patient progressed on EGFR targeted therapy)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Carcinoma, run by Genomic Health®, Inc. at 22 sites in 7 countries.
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 8 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: stopped early, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Chile, France, Spain, Japan and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 25 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 of Genomic Alterations in EGFR Detected in Plasma Versus Tumor Tissue in Stage IV Non Squamous NSCLC Patients Who Are Newly Diagnosed or Progressing on Treatment (time frame: Time between patient tumor tissue biopsy and and blood collection, up to 8 weeks). 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 17 Nov 2020.