Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06305715

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here