Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05116618
Other study ID # 20-1193.cc
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 6, 2022
Est. completion date September 15, 2022

Study information

Verified date September 2022
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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)


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 15, 2022
Est. primary completion date September 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: 1. Provision to sign and date the consent form 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Be aged 18 or older. 4. 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 5. Stage IV NSCLC disease according to AJCC 8th edition 6. 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: - CT/MRI for brain metastases - characteristic signs and/or symptoms indicating progression, - cytology, - imaging findings for leptomeningeal disease 7. 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 8. Prior CNS radiation therapy is allowed Exclusion Criteria: 1. 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 2. 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 3. Women who are documented as pregnant or breastfeeding

Study Design


Intervention

Diagnostic Test:
InVisionFirst-Lung ctDNA assay
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%.

Locations

Country Name City State
United States Colorado Research Center Aurora Colorado
United States USC Norris Comprehensive Cancer Center Los Angeles California
United States Georgetown University Washington District of Columbia

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver Inivata

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Determine the clinical outcomes of subsequent lines of therapy base on CNS data from this study ORR in CNS 3 years
Other Determine the clinical outcomes of subsequent lines of therapy base on CNS data from this study PFS in CNS 3 years
Other Determine the clinical outcomes of subsequent lines of therapy base on eCNS data from this study ORR in eCNS 3 years
Other Determine the clinical outcomes of subsequent lines of therapy base on eCNS data from this study PFS in eCNS 3 years
Other Determine the safety of CSF sampling for detection of resistance mechanisms in the context of CNS progression AEs associated with procedure 3 years
Primary 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)
3 years
Secondary 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
3 years
See also
  Status Clinical Trial Phase
Terminated NCT03087448 - Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Phase 1
Recruiting NCT05042375 - A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 3
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Terminated NCT05414123 - A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Recruiting NCT05009836 - Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03219970 - Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
Recruiting NCT05949619 - A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors Phase 1/Phase 2
Recruiting NCT04054531 - Study of KN046 With Chemotherapy in First Line Advanced NSCLC Phase 2
Withdrawn NCT03519958 - Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Terminated NCT02580708 - Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer Phase 1/Phase 2
Completed NCT01871805 - A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Terminated NCT04042480 - A Study of SGN-CD228A in Advanced Solid Tumors Phase 1
Recruiting NCT05919641 - LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
Completed NCT03656705 - CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma Phase 1