Detection of Resistance Mechanisms in Cerebrospinal Fluid for EGFR-mutant, ALK- and ROS1-rearranged

Withdrawn before enrolling

Conditions studied: Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT05116618

Run by

University of Colorado, Denver

People needed

0

Starts

2022-01-06

Expected to finish

2022-09-15

Last updated by the study team

2022-09-21

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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

You may not qualify if…

• 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
• 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

Where it is running

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Colorado Research Center — Aurora, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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