Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)
Medical College of Wisconsin
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).
Description
This is a prospective, two-part, single-arm, phase II trial that will evaluate whether the use of definitive radiation to the primary lung lesion prolongs PFS in treatment-naïve, metastatic, driver-mutated NSCLC patients who are subsequently put on a TKI. Part 1 will enroll up to 34 patients who are are treatment-naïve and have metastatic NSCLC. 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 (BED10) of 58 Gy. Immediately following the completion of radiation th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria Part 1 1. Age ≥18 years. 2. Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC). 3. An identifiable primary lung lesion must be present based on the consensus opinion of the medical oncology and radiation oncology investigators. 4. Patient did not previously receive radiation therapy to the primary lung lesion. Previous or concurrent palliative radiation to symptomatic metastatic lesions and definitive radiation to central nervous system metastases are allowable. 5. Patient must have advanced disease, either stage IV or stage IIIB/C…
Interventions
- DeviceRadiation 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.
- DrugTargeted 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.
Location
- Froedtert Hospital & the Medical College of WisconsinMilwaukee, Wisconsin