Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer

Recruiting now · Phase 2

Conditions studied: Non Small Cell Lung Cancer Stage

In brief

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

Key facts

Study ID: NCT04992780
Run by: University of Kansas Medical Center
People needed: 50
Starts: 2022-02-25
Expected to finish: 2026-11-01
Last updated by the study team: 2023-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
If a pleural effusion is present, it must be tapped and confirmed to be cytologically negative. If an effusion is deemed too small to safely tap, the subject will be eligible
Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 90 days following completion of therapy
Adequate organ function per laboratory results

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
Prior thoracic radiotherapy

Where it is running

The University of Kansas Cancer Center, Westwood Campus — Kansas City, Kansas, United States (enrolling)
The University of Kansas Cancer Center, Overland Park Clinic — Overland Park, Kansas, United States (enrolling)
The University of Kansas Cancer Center, North Clinic — Kansas City, Missouri, United States (enrolling)
The University of Kansas Cancer Center, Lee's Summit Clinic — Lee's Summit, Missouri, United States (enrolling)
University of Kansas Cancer Center, North Kansas City Hospital — North Kansas City, Missouri, United States (enrolling)
KUCC MCA- TUKHS, Saint Francis Hospital — Topeka, Kansas, United States

Full record on ClinicalTrials.gov

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