Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)
NCT06305715 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34
Last updated 2025-10-07
Summary
This prospective, two-part, single-arm, phase II trial is designed to evaluate whether the use of definitive radiation to the primary lung lesion prolongs progression-free survival (PFS) in treatment-naïve, metastatic, driver-mutated non-small cell lung cancers (NSCLC) patients who are subsequently placed on a tyrosine kinase inhibitor (TKI).
Conditions
- Non Small Cell Lung Cancer
Interventions
- DEVICE
-
Radiation Therapy
Enrolled subjects will be given radiation doses, at the discretion of the treating physicians, that range from 24-60 Gy in 1-15 fractions with a minimum biologically effective dose (BED\^10) of 58 Gy.
- DRUG
-
Targeted TKI therapy
Immediately following radiation therapy, subjects with an actionable driver mutation will receive a standard-of-care TKI. The choice of TKI will be at the discretion of the treating oncologist.
Sponsors & Collaborators
-
Medical College of Wisconsin
lead OTHER
Principal Investigators
-
Jonathan Thompson, MD, MS · Medical College of Wisconsin
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-18
- Primary Completion
- 2027-06-15
- Completion
- 2028-06-15
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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