NCT03667820

Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC

Phase II Trial of Osimertinib in Combination With Stereotactic Ablative Radiation (SABR) in EGFR Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the combination of two well-tolerated therapies, osimertinib and Stereotactic Ablative Radiation (SABR).

Detailed description

Patients with EGFR mutant non-small cell lung cancer will receive the current optimal therapy with osimertinib. After 8 weeks of targeted therapy, there will likely be some persisting lesions that would not have completely regressed. These persisting lesions would likely consist of cells that are less sensitive to targeted therapy. From the data summarized above \[14\], these persisting lesions are most to subsequently develop resistance and demonstrate progression. To delay the onset of clinical progression, lesions that persist after 8 weeks of osimertinib therapy and are amenable to stereotactic ablative radiation will be radiated. Osimertinib will be held for 3 days before the first dose of radiation and resumed 3 days after the last dose. After radiation, all patients will continue osimertinib therapy. If subsequently there is any evidence of progression, there will be an assessment of whether a repeat course of radiation is feasible. If it is feasible to repeat SABR to sites of progression, this will be performed and osimertinib resumed. If SABR is not possible, then a change in systemic therapy will be required.

Conditions

• Non-small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Osimertinib	Osimertinib 80mg tablet to be taken once daily.
RADIATION	SABR	Stereotactic Ablative Radiation (SABR)

Timeline

• Start date: 2018-09-26
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2018-09-12
• Last updated: 2025-11-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study