Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC

Part of paid clinical trials in Miami, Florida.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT03535363
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Oct 26, 2018
Status verified
Mar 2024
Primary completion
Apr 1, 2022
Completion
Apr 1, 2022

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Maximum Tolerated Dose of Osimertinib with standard of care
    For patients with 1-10 brain metastases, begin daily Osimeritinib 0-7 days prior to stereotactic radiosurgery (SRS), provide daily Osimeritinib concurrently with radiotherapy, followed by maintenance Osimeritinib until disease progression, withdrawal, or unacceptable toxicity. Dose Level 1: 80mg daily. Dose Level -1: 40mg daily

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Osimertinib with (SRS) [ Time Frame: 4 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Maimi Cancer Institute - Baptist Health South FloridaMiamiFlorida33176-
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-

Find similar trials in Miami, FL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Maimi Cancer Institute - Baptist Health South Florida· Miami, FLCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OH

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