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

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06305715
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation Therapy — DEVICE
    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.
  • Targeted TKI therapy — DRUG
    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.

Study Details

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).

Key Dates

Start date
Sep 18, 2024
Status verified
Oct 2025
Primary completion
Jun 15, 2027
Completion
Jun 15, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Radiation therapy followed by mutation-matched TKI treatment
    Part 1 will enroll subjects who will be given radiation doses at the discretion of the treating physicians. Subjects with actionable driver mutation will continue to Part 2 and receive a standard-of-care TKI at the discretion of the treating oncologist.

Primary Outcome Measure

Progression Free Survival [ Time Frame: Start of TKI treatment to 18 months ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Jonathan Thompson, MD, MS
[email protected]
414-805-4600

Find similar trials in Milwaukee, WI

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Froedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

Related Studies