Actively Recruiting
Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)
Led by Medical College of Wisconsin · Updated on 2025-10-07
34
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- Presence of an identifiable primary lung lesion confirmed by oncology investigators
- No prior radiation therapy to the primary lung lesion (palliative radiation to other metastatic sites or CNS is allowed)
- Advanced disease at stage IV or stage IIIB/C not suitable for definitive multi-modality therapy
- No prior targeted therapy for NSCLC; up to 2 cycles of standard chemotherapy allowed before enrollment
- Measurable disease based on RECIST v1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Ability and willingness to provide written informed consent
- Presence of an actionable driver mutation eligible for FDA-approved or NCCN-recommended front-line TKI therapy
You will not qualify if you...
- Expected prognosis less than 3 months
- Inability to swallow oral medications or gastrointestinal conditions impairing oral absorption
- Unresolved toxicities from prior cancer treatments greater than CTCAE grade 2 (except alopecia)
- Medical contraindications preventing safe delivery of radiation therapy
- Pregnancy or breastfeeding; females of childbearing potential must have negative pregnancy test within 14 days of enrollment
- Requirement for effective contraception for women of childbearing potential and sexually active males before enrollment, during treatment, and for 4 months after last targeted therapy
- Presence of prior or concurrent malignancies unless not interfering with study treatment evaluation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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