Comparing two radiation therapy methods for lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare hypofractionated intensity-modulated radiation therapy (IMRT) with standard-fractionated IMRT, both combined with chemotherapy and immunotherapy, for patients with non-small cell lung cancer (NSCLC) at stages IIIA or IIIB. The hypothesis is that the hypofractionated approach will improve locoregional control at 18 months by 10% compared to the standard method. Participants will receive either treatment regimen and will be monitored for disease progression and response to therapy. The study is designed as a Phase 2 interventional trial to assess the efficacy of the new treatment approach.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion 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

Where it's running

• The University of Kansas Cancer Center, Westwood Campus
  Kansas City, Kansas, United States Recruiting
• The University of Kansas Cancer Center, Overland Park Clinic
  Overland Park, Kansas, United States Recruiting
• The University of Kansas Cancer Center, North Clinic
  Kansas City, Missouri, United States Recruiting
• The University of Kansas Cancer Center, Lee's Summit Clinic
  Lee's Summit, Missouri, United States Recruiting
• University of Kansas Cancer Center, North Kansas City Hospital
  North Kansas City, Missouri, United States Recruiting
• KUCC MCA- TUKHS, Saint Francis Hospital
  Topeka, Kansas, United States Not yet recruiting

Study contacts

• Principal investigator: Krishna Reddy, MD, PhD — University of Kansas Medical Center
• Study coordinator: KUCC Navigation
• Email: kucc_navigation@kumc.edu
• Phone: 913-588-3671

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.