NCT06305715

Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 therapy, patients who have an actionable driver mutation will be eligible to continue on to Part 2 of the study; those who do not meet the eligibility criteria for Part 2 will discontinue trial participation. Twenty-nine subjects will receive a standard-of-care targeted TKI therapy. The choice of TKI will be at the discretion of the treating oncologist, provided that their decision aligns with preferred TKIs per National Comprehensive Cancer Network (NCCN) guidelines. While on TKI therapy, patients will be assessed every three months for disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and survival.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-18
• Primary completion: 2027-06-15
• Completion: 2028-06-15
• First posted: 2024-03-12
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study