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

NCT06305715 | Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: PRO00051658
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Non Small Cell Lung Cancer

Keywords

non-small cell lung cancer; radiation therapy; tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The number of subjects without tumor progression based on RECIST v1.1 or death, whichever comes first. This will be measured from the start of TKI treatment until 18 months.

  Start of TKI treatment to 18 months

Study Arms (1)

Radiation therapy followed by mutation-matched TKI treatment

EXPERIMENTAL

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.

Device: Radiation Therapy; Drug: Targeted TKI therapy

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.

Radiation therapy followed by mutation-matched TKI treatment

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.

Radiation therapy followed by mutation-matched TKI treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC).
• An identifiable primary lung lesion must be present based on the consensus opinion of the medical oncology and radiation oncology investigators.
• 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.
• Patient must have advanced disease, either stage IV or stage IIIB/C that is not amenable to definitive multi-modality therapy.
• Patient must not have received prior targeted therapy for NSCLC. A subject may receive up to 2 cycles of standard cytotoxic chemotherapy for NSCLC prior to trial enrollment. For example, a cycle of carboplatin and pemetrexed is given once every 3 weeks.
• Patient must have measurable disease as defined by RECIST v1.1.
• Patient must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.
• Ability to understand a written informed consent document, and the willingness to sign it.
• \. Must have an actionable driver mutation for which an Food and Drug Administration (FDA) -approved and/or National Comprehensive Cancer Network (NCCN) -recommended front-line TKI is available.

You may not qualify if:

• Anticipated prognosis \< 3 months.
• Inability to swallow oral medications or history of GI abnormality that would impair absorption of oral medications.
• Patients with prior or concurrent malignancy are eligible provided the investigator assesses this malignancy does not have potential to interfere with evaluation of the safety or efficacy of the study treatments.
• Patient must not have any unresolved toxicities from prior cancer therapy greater than CTCAE grade 2 at time of study enrollment. Any grade alopecia is allowable.
• Patient must not have medical contraindications, as determined by treating radiation oncologist, that would preclude safe delivery of radiation therapy.
• Women must not be pregnant or breast-feeding. All females of childbearing potential must have negative blood or urine pregnancy testing within 14 days of study enrollment.
• Women of childbearing potential and sexually active males must use effective methods of contraception for 14 days prior to study enrollment, while on study treatment, and for 4 months after the last targeted therapy treatment.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jonathan Thompson, MD, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: September 18, 2024
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 15, 2028
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)