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RecruitingPhase 2NCT04992780
Official study title

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

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedHypo-Fractionation and Standard-Fractionation

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 7, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?University of Kansas Medical Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Kansas Medical Center
Interventions being studied
Radiation: Hypo-Fractionation; Radiation: Standard-Fractionation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Immunotherapy→Chemotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • The University of Kansas Cancer Center, Westwood CampusKansas City, Kansas
  • The University of Kansas Cancer Center, Overland Park ClinicOverland Park, Kansas
  • KUCC MCA- TUKHS, Saint Francis HospitalTopeka, Kansas
  • The University of Kansas Cancer Center, North ClinicKansas City, Missouri
  • The University of Kansas Cancer Center, Lee's Summit ClinicLee's Summit, Missouri
  • University of Kansas Cancer Center, North Kansas City HospitalNorth Kansas City, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 7, 2023. Always confirm current availability with the study team.

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