Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC
Investigating potential of controlling brain metastases in patients with EGFR positive NSCLC.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 13, 2024 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Case Comprehensive Cancer Center
- Interventions being studied
- Drug: Osimertinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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.
- 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Maimi Cancer Institute - Baptist Health South FloridaMiami, Florida
- Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 13, 2024. Always confirm current availability with the study team.