RecruitingNon Small Cell Lung Cancer Stage
Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
The hypothesis for this study is that hypofractionated IMRT to 62.5 Gy in 25 fractions (2.5 Gy/fraction) with concurrent carboplatin and paclitaxel, followed by maintenance durvalumab will improve locoregional control at 18 months by 10% compared to standard-fractionated chemo-IMRT/durvalumab. A modest improvement in locoregional control (LRC) was selected as a target which could merit further study of this hypofractionated IMRT regimen in a Phase III trial
Sponsor: University of Kansas Medical Center
You may qualify if…
- ✓ Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- ✓ Males and females age ≥ 18 years
- ✓ Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2
- ✓ Measurable disease by RECIST 1.1
- ✓ Women of childbearing potential must have a negative serum pregnancy test within one month prior to initiating treatment
- ✓ Pathologically proven diagnosis of Stage IIIA or IIIB non-small cell lung cancer (NSCLC)
- ✓ No Positron Emission Tomography (PET)/CT evidence of metastatic disease
- ✓ An MRI of the brain with contrast excluding intracranial metastatic disease (or CT with contrast if MRI is medically contraindicated). An MRI without contrast is only permitted if the subject cannot have contrast for medical reasons
You may not qualify if…
- ✕ Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
- ✕ Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- ✕ Evidence of severe or systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) that would interfere with study protocol as judged by the investigator
- ✕ Is pregnant or breastfeeding
- ✕ Active connective tissue disorders, such as active lupus or scleroderma
- ✕ Known Acquired Immune Deficiency (HIV (+)/AIDS)
- ✕ Has a known allergic reaction to any excipient contained in the study drug formulations
- ✕ Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
Where it's recruiting
Source: ClinicalTrials.gov · NCT04992780 · last updated 2023-12-07