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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03535363
Other study ID # CASE3517
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 26, 2018
Est. completion date April 1, 2022

Study information

Verified date March 2024
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigating potential of controlling brain metastases in patients with EGFR positive NSCLC.


Description:

In patients with EGFR positive NSCLC with 1-10 brain metastases, we are investigating whether we can control the macro brain metastases with Stereotactic Radiosurgery (SRS) and control the micro metastases with targeted agent Osimertinib and avoid whole brain radiation that could potentially lead to significant cognitive decline.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Confirmed pathology of EGFR mutation positive NSCLC with new brain metastases. - Ability to care for self and ability to walk 50% of waking hours (ECOG Performance Status of 0-2) - 1-10 brain metastases with intra-cranial brain metastasis must measure 3cm or less in the greatest dimension. - Hemoglobin =9 g/dL, White Blood Count Absolute =3.0 x 10^9/L, Granulocyte count =1.5 x 10^9/L, and platelet count =100 x 10^9/L - Serum Bilirubin = 1.5 x upper limit of normal (ULN) - AST and/or ALT = 2 ULN (= 5 x ULN when clearly attributable to liver metastases) - Serum creatinine = 1.5 ULN or calculated creatinine clearance > 60ml/min - For women of childbearing potential-Negative pregnancy test within one week prior to start of therapy. - For all sexually active male and female patients of reproductive potential, employ two methods of highly effective and acceptable forms of contraception throughout the study and for 120 days following the final dose of osimertinib. Exclusion Criteria: - Patients with leptomeningeal metastases documented by MRI or cerebrospinal fluid (CSF). - Significant intratumoral or peritumoral hemorrhage - Brain metastases within 5 mm of the optic chiasm or optic nerve - Brainstem metastases - Gastrointestinal disorders with diarrhea as a major symptom - Clinically significant or uncontrolled cardiac disease (NYHA functional classification of 3 or 4) - Pre-existing interstitial lung disease or pneumonitis - Unable to undergo brain MRI - HIV or Hepatitis B or C - Prior treatments must be resolved to an asymptomatic state at time of enrollment - Medical conditions that could cause safety risks - Currently receiving investigational cancer therapy. - Mean QT interval corrected heart rate (QTc)=470ms calculated from 3 EKGs - Left Ventricular Ejection Fraction (LVEF) = 50% - Use of strong CYP3A inhibitors - Use of strong CYP3A4 inducers - Use of potent CYP2C8 inhibitors - Hypersensitivity to osimertinib or any of its ingredients - corneal ulceration - pregnant or breast-feeding

Study Design


Intervention

Drug:
Osimertinib
Drug: Osimertinib 80mg or 40mg

Locations

Country Name City State
United States Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center Cleveland Ohio
United States Maimi Cancer Institute - Baptist Health South Florida Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) of Osimertinib with (SRS) To determine the safety, tolerability and maximum tolerated dose of Osimertinib, when administered in combination with SRS in patients with EGFR positive NSCLC with brain metastases. 4 weeks
Secondary Number of patients with progression free survival To assess the six-month intra-cranial and extra-cranial progression-free survival (PFS-6) in patients with EGFR positive NSCLC brain metastases treated with Osimertinib and SRS (PFS is defined as the time from clinical registration to intra-or extra-cranial tumor progression or death) 6 months
Secondary Length of overall survival To assess the overall survival (OS) in patients with EGFR positive NSCLC Brain Metastases treated with Osimertinib and SRS 2 years
Secondary Difference in outcome vs. standard of care To compare results of our clinical trial to patients with EGFR positive NSCLC with brain metastases treated with SRS alone (1-10 brain Metastases) 2 years
Secondary Intra-cranial and Extra-cranial Overall Response Rate (ORR) To assess Overall response rate (ORR) both intracranial and extracranial, defined as the proportion of patients with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by the investigator. 6 months
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