Smart radiation planning may ease lung cancer treatment side effects
NCT ID NCT04751747
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether updating radiation treatment plans at set times (adaptive planning) can lower side effects like lung inflammation in people with stage II-IV non-small cell lung cancer. About 34 participants will receive standard radiation and immunotherapy, but their treatment plan will be adjusted periodically to account for tumor shrinkage. The goal is to see if this approach reduces damage to healthy tissue compared to historical data.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- 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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Feb 2021
- Expected to finish
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Dec 2027
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: * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information * Histologically or cytological evidence of locally advanced, biopsy-proven, stage II (inoperable), III-or oligometastatic stage IV NSCLC planned to be treated with chemoradiation with concurrent or adjuvant immunotherapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ and marrow laboratory values for radiation therapy deemed by appropriate the investigator obtained within 14 days prior to registration for protocol therapy * Women of childbearing potential (WOCBP) must obtain a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) at day -30 to day 0 * Women of childbearing potential must be willing to abstain from heterosexual activity or use an effective method of contraception during the time of the study period * Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year Exclusion Criteria: * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the site investigator * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial * Active central nervous system (CNS) metastases (if symptomatic or without prior brain imaging, subjects must undergo a head computed tomography \[CT\] scan or brain magnetic resonance imaging \[MRI\] within 28 days prior to registration for protocol therapy to exclude brain metastases) * Treatment with any investigational agent within 28 days prior to registration for protocol therapy * Prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer other than standard concurrent chemoradiation or up to 2 cycles of consolidation therapy * Active second cancers * History of psychiatric illness or social situations that would limit compliance with study requirements
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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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RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903, United States
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Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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