Clinical trial · Interventional
Osimertinib With Stereotactic Radiosurgery (SRS) in Brain Metastases From EGFR Positive NSCLC
Phase 1 Trial of Osimertinib With Stereotactic Radiosurgery (SRS) in Patients With Brain Metastases From EGFR Positive Non-Small-Cell Lung Cancer (NSCLC)
NCT03535363CI-TRIAL-00075027completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Investigating potential of controlling brain metastases in patients with EGFR positive NSCLC.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Maximum Tolerated Dose of Osimertinib with standard of care
- description
- 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
- interventionNames
- Drug: Osimertinib
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Osimertinib with (SRS)
- timeFrame
- 4 weeks
- description
- 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.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.