NCT06741085

A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain

ICON-RT: Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.

Detailed description

Patients in both arms of this study will receive standard of care (SOC) systemic therapy which includes a backbone of an FDA-approved CNS-active TKI targeting mutant EGFR, specifically osimertinib.

Conditions

• Non Small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	osimertinib	oral EGFR-TKI
RADIATION	stereotactic radiosurgery (SRS)	0-20mm-18Gy x 1, 21Gy x 1 ,9Gy x 3 20mm or larger- 9Gy x 3, 6Gy x 5, 5Gy x 5

Timeline

• Start date: 2024-12-13
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-12-18
• Last updated: 2026-04-13

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study