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Tailoring radiation by tumor genes: a tiny step toward smarter lung cancer treatment

NCT ID NCT05873439

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

May 2023

Finished

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

18 years and older

Sex

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

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

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.