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

Conditions

• Non Small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Dec 13, 2024

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

56 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: osimertinib and stereotactic radiosurgery (SRS)
• Active Comparator: osimertinib alone (standard systemic therapy)

Primary Outcome Measure

intracranial progression-free survival (iPFS) [ Time Frame: 3 months ]

Central Contacts

• Luke Pike, MD
  212-639-8157
  [email protected]
• Helena Yu, MD
  646-608-3912

Locations (8)

Find similar trials in Miami, FL

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