Non-Small Cell Lung CancerNCT05116618
Detection of Resistance Mechanisms in Cerebrospinal Fluid for EGFR-mutant, ALK- and ROS1-rearranged
An observational study of Non-Small Cell Lung Cancer, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
To determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid (CSF) for patients with CNS progression (with or without extra-CNS (eCNS) progression) and concordance with plasma/tissue Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- InVisionFirst-Lung ctDNA assay
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 6 Jan 2022to 15 Sep 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with stage IV EGFR, ALK, or ROS1-mutant NSCLC who had CNS progression after at least 6 months of stable CNS disease on a relevant TKI are screened. Patients must meet all Inclusion/Exclusion Criteria to participate in the study.
Who may be able to join
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be aged 18 or older.
- Pathologically confirmed NSCLC with EGFR-mutation, or ALK- or ROS1-rearrangement and currently on an EGFR, or ALK or ROS1 tyrosine-kinase inhibitor (TKI) as applicable
- Stage IV NSCLC disease according to AJCC 8th edition
- Known CNS metastasis prior to current line of therapy with CR/PR/SD for at least 6 months (not purely attributable to prior local therapy such as radiation) on current EGFR, or ALK or ROS1 TKI, confirmed by at least one of the following modalities:
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- CT/MRI for brain metastases
- characteristic signs and/or symptoms indicating progression,
- cytology,
- imaging findings for leptomeningeal disease
- Confirmed current CNS progression, with or without eCNS progression, on the same TKI based on at least one of the following modalities:
- CT/MRI for brain metastases
- characteristic signs and/or symptoms indicating progression,
- cytology,
- imaging findings for leptomeningeal disease
- Prior CNS radiation therapy is allowed
Who cannot join
- Has contraindications to receive a lumbar puncture which may include, but are not limited to the following, at the discretion of the patient's oncologist or physician performing the LP:
- Clinical and/or radiographic evidence of mass effect of raised intracranial pressure (ICP) with risk for cerebral herniation
- Thrombocytopenia (defined as platelet count ≤ 50 or per local guidelines) or other bleeding diathesis
- Currently on antiplatelet or anticoagulant therapy at time of consent, for which the thrombosis risk of holding for LP is deemed unacceptable
- Suspected spinal epidural abscess
- Any other condition determined by the clinician to be a contraindication
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- History of a second primary malignancy (including a second primary lung cancer) with the exceptions for:
- Malignancy treated with curative intent and with no known active disease ≥5 years, and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Women who are documented as pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Colorado Research Center
Aurora, Colorado, 80045
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Detection of Resistance Mechanisms in Cerebrospinal Fluid for EGFR-mutant, ALK- and ROS1-rearranged Non-small Cell Lung Cancer Patients With Central Nervous System (CNS) Progression After Evidence of Prior CNS Benefit on Relevant Tyrosine Kinase Inhibitors
To determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid (CSF) for patients with CNS progression (with or without extra-CNS (eCNS) progression) and concordance with plasma/tissue
Read the detailed description
To determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid (CSF) for patients with CNS progression (with or without extra-CNS (eCNS) progression) and concordance with plasma/tissue
- For each individual patient with CNS progression (with or without eCNS progression), compare the molecular status (primary oncogene detection and any mechanisms of identifiable resistance including EGFR-, ALK- and ROS1-mutations, ALK-amplification and bypass-tracks activating mutations) of CSF, plasma and CNS tissue (if data from pathology report is available)
- Molecular status will also be compared with previously obtained and stored plasma/tissue prior to the initiation of current next-generation tyrosine-kinase inhibitor (TKI)
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- InVisionFirst-Lung ctDNA assay
- Keywords
- Progression, Central Nervous System
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InVisionFirst-Lung ctDNA assayDiagnostic test
An enhanced tagged/targeted-amplicon sequencing technology for detection of genomic alterations in 36 commonly mutated genes in plasma ctDNA with a sensitivity of 73.9% and specificity of 99.8%.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | 10 evaluable enrollments to Cohort 1 with EGFR-mutant NSCLC Receives: Diagnostic Test: InVisionFirst-Lung ctDNA assay | |
| Cohort 2 | 10 evaluable enrollments to Cohort 2 with ALK-rearranged NSCLC Receives: Diagnostic Test: InVisionFirst-Lung ctDNA assay | |
| Cohort 3 | 10 evaluable enrollments to Cohort 3 with ROS1-rearranged NSCLC Receives: Diagnostic Test: InVisionFirst-Lung ctDNA assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid (CSF) for patients with CNS progression (with or without extra-CNS (eCNS) progression) and concordance with plasma/tissue
- For each individual patient with CNS progression (with or without eCNS progression), compare the molecular status (primary oncogene detection and any mechanisms of identifiable resistance including EGFR-, ALK- and ROS1-mutations, ALK-amplification and bypass-tracks activating mutations) of CSF, plasma and CNS tissue (if data from pathology report is available)
- Molecular status will also be compared with previously obtained and stored plasma/tissue prior to the initiation of current next-generation tyrosine-kinase inhibitor (TKI)
Measured: 3 years
Secondary outcomes (1)
Compare and contrast mechanisms of resistance in CNS progression versus eCNS progression
- For patients with both CNS and eCNS progression, compare distribution of resistance mechanisms between CSF, plasma, CNS tissue (if data from pathology report is available) and tissue from site of eCNS progression (if data from pathology report is available)
- Compare distribution of resistance mechanisms in CSF for all patients with CNS progression (with or without eCNS progression) to historical data of distribution of resistance mechanisms to next-generation TKI from ctDNA/tumor tissue samples
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start6 Jan 2022
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Why it stopped: Cancelled by Sponsor
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.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Inivata
- Responsible party
- Sponsor
- Investigators
- Ross Camidge, Principal investigator, Colorado Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116618
- Sponsor's protocol ID
- 20-1193.cc
- Status last verified
- Sep 2022
- First submitted
- 1 Nov 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No: whole study will be presented
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Resistance Mechanisms in Cerebrospinal Fluid for EGFR-mutant, ALK- and ROS1-rearranged Non-small Cell Lung Cancer Patients With Central Nervous System (CNS) Progression After Evidence of Prior CNS Benefit on Relevant Tyrosine Kinase Inhibitors
- ClinicalTrials.gov ID
- NCT05116618
- Acronym / sponsor ID
- 20-1193.cc
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Progression, Central Nervous System
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Cancelled by Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Inivata
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 11 Nov 2021 (actual)
- 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.
To determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid (CSF) for patients with CNS progression (with or without extra-CNS (eCNS) progression) and concordance with plasma/tissue
Detailed description
To determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid (CSF) for patients with CNS progression (with or without extra-CNS (eCNS) progression) and concordance with plasma/tissue
- For each individual patient with CNS progression (with or without eCNS progression), compare the molecular status (primary oncogene detection and any mechanisms of identifiable resistance including EGFR-, ALK- and ROS1-mutations, ALK-amplification and bypass-tracks activating mutations) of CSF, plasma and CNS tissue (if data from pathology report is available)
- Molecular status will also be compared with previously obtained and stored plasma/tissue prior to the initiation of current next-generation tyrosine-kinase inhibitor (TKI)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: InVisionFirst-Lung ctDNA assay10 evaluable enrollments to Cohort 1 with EGFR-mutant NSCLC |
| Cohort 2 | – | Diagnostic Test: InVisionFirst-Lung ctDNA assay10 evaluable enrollments to Cohort 2 with ALK-rearranged NSCLC |
| Cohort 3 | – | Diagnostic Test: InVisionFirst-Lung ctDNA assay10 evaluable enrollments to Cohort 3 with ROS1-rearranged NSCLC |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with stage IV EGFR, ALK, or ROS1-mutant NSCLC who had CNS progression after at least 6 months of stable CNS disease on a relevant TKI are screened. Patients must meet all Inclusion/Exclusion Criteria to participate in the study.
Key inclusion criteria (16 listed)
- Provision to sign and date the consent form
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be aged 18 or older.
- Pathologically confirmed NSCLC with EGFR-mutation, or ALK- or ROS1-rearrangement and currently on an EGFR, or ALK or ROS1 tyrosine-kinase inhibitor (TKI) as applicable
- Stage IV NSCLC disease according to AJCC 8th edition
Key exclusion criteria (11 listed)
- Has contraindications to receive a lumbar puncture which may include, but are not limited to the following, at the discretion of the patient's oncologist or physician performing the LP:
- History of a second primary malignancy (including a second primary lung cancer) with the exceptions for:
- Women who are documented as pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InVisionFirst-Lung ctDNA assayAn enhanced tagged/targeted-amplicon sequencing technology for detection of genomic alterations in 36 commonly mutated genes in plasma ctDNA with a sensitivity of 73.9% and specificity of 99.8%. | Diagnostic test | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid (CSF) for patients with CNS progression (with or without extra-CNS (eCNS) progression) and concordance with plasma/tissue
Time frame: 3 years
* For each individual patient with CNS progression (with or without eCNS progression), compare the molecular status (primary oncogene detection and any mechanisms of identifiable resistance including EGFR-, ALK- and ROS1-mutations, ALK-amplification and bypass-tracks activating mutations) of CSF, plasma and CNS tissue (if data from pathology report is available) * Molecular status will also be compared with previously obtained and stored plasma/tissue prior to the initiation of current next-generation tyrosine-kinase inhibitor (TKI)
1 secondary outcome
Compare and contrast mechanisms of resistance in CNS progression versus eCNS progression
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No. whole study will be presented
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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.
Ross Camidge principal investigator
Colorado Research Center
3 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 University of Colorado, Denver at 3 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 16 inclusion and 11 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: withdrawn, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 was withdrawn before enrolling participants, so there are no results.
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?
Determine the detection rate of driver oncogenes and resistance mechanisms in cerebrospinal fluid (CSF) for patients with CNS progression (with or without extra-CNS (eCNS) progression) and concordance with plasma/tissue (time frame: 3 years). 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 21 Sep 2022.