N/A
N=35
Hypofractionated Radiation Therapy to Improve Immunotherapy Response in Non-Small Cell Lung Cancer
Non Small Cell Lung Cancer Metastatic
Bottom Line
View on ClinicalTrials.gov: NCT03035890 ↗Enrolled (actual)
35
Serious AEs
71.4%
Results posted
Apr 2025
Primary outcome: Primary: Time to Best Overall Response — 14 months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Radiation (Radiation); Immuno-Therapeutic Agent (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- West Virginia University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Best Overall Response |
14 | — |
| SECONDARY Time to Progression Free Survival |
6.9 | — |
| SECONDARY Overall Survival |
15 | — |
Summary
This study includes the additional use of radiation therapy in combination immunotherapy in order to determine whether the radiation may improve the response of non-small cell lung cancer to immunotherapy and to monitor any side effects.
Eligibility Criteria
Inclusion Criteria
- Stage IV metastatic Non Small Cell Lung Cancer
- Measurable disease of at least 1.5 cm in greatest dimension at least 2 non-irradiated sites (except for lymph nodes, in which the short-axis dimension must be at least 1.5cm). There must be at least 1 visceral organ metastasis outside of the brain.
- History of prior cytotoxic chemotherapy (with or without concomitant radiation therapy) with subsequent distant (metastatic) disease relapse, or progression of disease while on chemotherapy.
- Participant must be planned to receive (or actively receiving) standard of care checkpoint inhibitor immune therapy. For those patients actively receiving checkpoint inhibitor immune therapy the duration of immune therapy at the time of enrollment must be 4 months or less.
- Life expectancy greater than 3 months
Exclusion Criteria
- Active autoimmune disease, primary immunodeficiency syndrome, HIV/AIDS, or hepatitis B or C
- Oral corticosteroid dependency
- Uncontrolled or untreated active brain metastases/CNS disease
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia
Data sourced from ClinicalTrials.gov (NCT03035890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.