Tailoring radiation by tumor genes: a tiny step toward smarter lung cancer treatment
NCT ID NCT05873439
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This small, completed study tested whether it is possible to personalize radiation doses for people with stage II or III non-small cell lung cancer based on the genetic profile of their tumor. Three participants received either standard or higher radiation doses depending on a radiosensitivity index from their biopsy. The goal was to see if this approach is feasible and safe, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy
- What this could lead to
- If successful, this approach could lead to more effective radiation dosing for lung cancer, potentially improving tumor control while managing side effects.
- What could go wrong
- This is a very early feasibility study with only 3 participants, so results may not apply broadly. Higher radiation doses also carry a risk of serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
3 people
The number who actually took part.
- Started
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May 2023
- Finished
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Aug 2024
- Lead sponsor
-
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
-
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: * Diagnosis of AJCC Stage 2 or Stage 3 unresectable NSCLC as determined by a multidisciplinary oncology team * Confirmation of NSCLC with availability of fresh tumor biopsy by tissue biopsy which can include adenocarcinoma, squamous cell, large cell carcinoma, or NSCLC not otherwise specified * Life expectancy \>12 weeks * Normal renal (creatinine \<1.5 × upper limit of normal \[ULN\]), liver (bilirubin \< 1.5 × ULN, transaminases \<3.0 × ULN, except in known hepatic disease, wherein may be \<5 × ULN) and blood counts (white blood cells ≥2.5, neutrophils ≥1000, platelets ≥50, 000, hemoglobin ≥8) * ECOG 0-1 * Age ≥ 18 years * Participants with surgery within 14 days should have recovered from all effects of the surgery and be cleared by their surgeon * There is no limit on prior systemic or therapies * Women of childbearing potential and sexually active males must commit to the use of effective contraception while on study * Ability to sign an informed consent form, which can be signed by a family member or health care proxy. Informed consent must be given before any study related procedures occur. Exclusion Criteria: * Current or prior participation in a study of an investigational agent or investigational device within 2 weeks of the first dose of study treatment * Major surgery or significant traumatic injury that has not been recovered from 14 days before the initiation of study drug * Women who are pregnant or breastfeeding * History of allergy or hypersensitivity to any of the study drugs or study drug components * Concurrent brain metastases or leptomeningeal disease * History of prior malignancy within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS of \> 90%), such as but not limited to, non-melanoma skin carcinoma, ductal carcinoma in situ, or stage I endometriod uterine cancer, and others at the discretion of the PI * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion: * • Patients with vitiligo or alopecia * • Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement * • Any chronic skin condition that does not require systemic therapy * • Patients without active disease in the last 5 years may be included but only after consultation with the Principal Investigator * • Patients with celiac disease controlled by diet alone * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: * • Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection) * • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent * • Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
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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.
Contacts and locations
Locations
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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