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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment34 people
  • Recruiting US sites1
  • SponsorMedical College of Wisconsin
  • RegistryNCT06305715

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Radiation Prior to TKI to Delay Progression in Advanced Driver-Mutated Non-small Cell Lung Cancers (RadiaNCe Lung X): a one-minute explainerNCT063057151 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • Inclusion Criteria Part 1
  • 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.
  • Inclusion Criteria Part 2
  • 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 cannot join 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • 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.

The study

Treatment groups

Na · Single Group · masking: None

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.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • radiation: Part of the study plan

Goals

What the study measures

Main goals

  • Progression Free Survival (Start of TKI treatment to 18 months)

Planned enrollment: 34 (estimated).

Where

Recruiting US sites

  • Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 18, 2026. Public record; not medical advice.

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