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

Description

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

Conditions

Non Small Cell Lung Cancer Stage

Talk to us

Study Overview

On this page

Study Details

Study overview

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

A Randomized Phase II Trial of Hypo-fractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction Versus (VS) Standard-Fractionated IMRT, Concurrent With Carboplatin/Paclitaxel and Followed by Consolidation Durvalumab, for Subjects With Stage 2A/B Non-Small Cell Lung Cancer

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

Condition
Non Small Cell Lung Cancer Stage
Intervention / Treatment

-

Contacts and Locations

Kansas City

The University of Kansas Cancer Center, Westwood Campus, Kansas City, Kansas, United States, 66205

Overland Park

The University of Kansas Cancer Center, Overland Park Clinic, Overland Park, Kansas, United States, 66210

Topeka

KUCC MCA- TUKHS, Saint Francis Hospital, Topeka, Kansas, United States, 66606

Kansas City

The University of Kansas Cancer Center, North Clinic, Kansas City, Missouri, United States, 64154

Lee's Summit

The University of Kansas Cancer Center, Lee's Summit Clinic, Lee's Summit, Missouri, United States, 64064

North Kansas City

University of Kansas Cancer Center, North Kansas City Hospital, North Kansas City, Missouri, United States, 64116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Kansas Medical Center,

Krishna Reddy, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

2026-11