Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
NCT ID: NCT04992780
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
50 participants
INTERVENTIONAL
2022-02-25
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Hypo-Fractionation
Participants will receive one fraction of radiation therapy a day for 5 days each week for 5 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin area under the curve (AUC) 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.
Hypo-Fractionation
62.5 Gy in 25 fractions of 2.5 Gy/fraction
Standard-Fractionation
Participants will receive one fraction of radiation therapy a day for 5 days each week for 6 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin AUC 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.
Standard-Fractionation
60 Gy in 30 fractions of 2 Gy/fraction
Interventions
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Hypo-Fractionation
62.5 Gy in 25 fractions of 2.5 Gy/fraction
Standard-Fractionation
60 Gy in 30 fractions of 2 Gy/fraction
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Krishna Reddy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, United States
KUCC MCA- TUKHS, Saint Francis Hospital
Topeka, Kansas, United States
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, United States
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, United States
University of Kansas Cancer Center, North Kansas City Hospital
North Kansas City, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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KUCC Navigation
Role: primary
Clinical Trials Nurse Navigator
Role: primary
KUCC Navigation
Role: primary
Clinical Trials Nurse Navigator
Role: primary
Clinical Trials Nurse Navigator
Role: primary
Nurse Navigator
Role: primary
Other Identifiers
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IIT-2021-LU-HypoIMRT
Identifier Type: -
Identifier Source: org_study_id