Radiation before pills may slow lung cancer progression
NCT ID NCT06305715
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving radiation to the main lung tumor before starting targeted therapy pills can delay cancer growth in people with advanced, gene-mutated non-small cell lung cancer. About 34 adults who have not yet had treatment will receive radiation to the primary lung lesion, then take a tyrosine kinase inhibitor (TKI). The goal is to see if this combination keeps the cancer from progressing longer than TKI alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria Part 1 1. Age ≥18 years. 2. Patient must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC). 3. An identifiable primary lung lesion must be present based on the consensus opinion of the medical oncology and radiation oncology investigators. 4. 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. 5. Patient must have advanced disease, either stage IV or stage IIIB/C that is not amenable to definitive multi-modality therapy. 6. 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. 7. Patient must have measurable disease as defined by RECIST v1.1. 8. Patient must have Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2. 9. Ability to understand a written informed consent document, and the willingness to sign it. Inclusion Criteria Part 2 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. Exclusion Criteria: 1. Anticipated prognosis \< 3 months. 2. Inability to swallow oral medications or history of GI abnormality that would impair absorption of oral medications. 3. 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. 4. 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. 5. Patient must not have medical contraindications, as determined by treating radiation oncologist, that would preclude safe delivery of radiation therapy. 6. 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. 7. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Froedtert Hospital & the Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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