Non Small Cell Lung CancerPhase 2NCT06305715
Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X)
A Phase 2 study testing Radiation Therapy and Targeted TKI therapy in people with Non Small Cell Lung Cancer, run by Medical College of Wisconsin at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Radiation Therapy and Targeted TKI therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2024to 15 Jun 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 1. 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Medical College of Wisconsin Cancer Center Clinical Trials Office contact
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Jonathan Thompson, MD, MS, 414-805-4600, jrthomps@mcw.edu
About this study
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).
Read the 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
- Being tested
- Radiation Therapy, Targeted TKI therapy
- Keywords
- non-small cell lung cancer, radiation therapy, tyrosine kinase inhibitor
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyDevice
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 therapyDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Radiation Therapy; Drug: Targeted TKI therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Start of TKI treatment to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start18 Sep 2024
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Thompson, MD, MS, Medical College of Wisconsin
- Investigators
- Jonathan Thompson, MD, MS, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305715
- Sponsor's protocol ID
- PRO00051658
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2024
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No