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

Last updated: December 5, 2023
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Standard-Fractionation

Hypo-Fractionation

Clinical Study ID

NCT04992780
IIT-2021-LU-HypoIMRT
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability of participant OR Legally Authorized Representative (LAR) to understand thisstudy, 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 onemonth 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 CTwith contrast if MRI is medically contraindicated). An MRI without contrast is onlypermitted if the subject cannot have contrast for medical reasons
  • If a pleural effusion is present, it must be tapped and confirmed to be cytologicallynegative. If an effusion is deemed too small to safely tap, the subject will beeligible
  • Women of child-bearing potential and men with partners of child-bearing potential mustagree to practice sexual abstinence or to use the forms of contraception listed inChild-Bearing Potential/Pregnancy section for the duration of study participation andfor 90 days following completion of therapy
  • Adequate organ function per laboratory results

Exclusion

Exclusion Criteria:

  • Current or anticipating use of other anti-neoplastic or investigational agents whileparticipating in this study
  • Diagnosed with a psychiatric illness or is in a social situation that would limitcompliance 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 judgedby 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 drugformulations
  • Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungalinfection within 2 weeks prior to the first dose of study treatment
  • Prior thoracic radiotherapy

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Standard-Fractionation
Phase: 2
Study Start date:
February 25, 2022
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • The University of Kansas Cancer Center, Westwood Campus

    Kansas City, Kansas 66205
    United States

    Active - Recruiting

  • The University of Kansas Cancer Center, Overland Park Clinic

    Overland Park, Kansas 66210
    United States

    Active - Recruiting

  • KUCC MCA- TUKHS, Saint Francis Hospital

    Topeka, Kansas 66606
    United States

    Site Not Available

  • The University of Kansas Cancer Center, North Clinic

    Kansas City, Missouri 64154
    United States

    Active - Recruiting

  • The University of Kansas Cancer Center, Lee's Summit Clinic

    Lee's Summit, Missouri 64064
    United States

    Active - Recruiting

  • The University of Kansas Medical Center

    North Kansas City, Missouri 64116
    United States

    Active - Recruiting

  • University of Kansas Cancer Center, North Kansas City Hospital

    North Kansas City, Missouri 64116
    United States

    Active - Recruiting

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