RecruitingPhase 2NCT04992780

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

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


Sponsor

University of Kansas Medical Center

Enrollment

50 participants

Start Date

Feb 25, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches to radiation therapy — a shorter, higher-dose schedule (hypofractionated IMRT) versus the traditional longer schedule (standard IMRT) — both given alongside chemotherapy and immunotherapy for patients with stage III non-small cell lung cancer that cannot be surgically removed. **You may be eligible if...** - You are 18 or older with confirmed stage IIIA or IIIB non-small cell lung cancer - Your cancer has not spread to other parts of the body (no metastases on PET/CT or brain MRI) - You are in reasonably good health (ECOG 0–2) - You have adequate organ function - Women of childbearing age must have a negative pregnancy test **You may NOT be eligible if...** - You have had prior chest (thoracic) radiation - You have HIV/AIDS - You have active autoimmune connective tissue disease (e.g., lupus, scleroderma) - You have a serious active infection - You are pregnant or breastfeeding - You are currently on other anti-cancer treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHypo-Fractionation

62.5 Gy in 25 fractions of 2.5 Gy/fraction

RADIATIONStandard-Fractionation

60 Gy in 30 fractions of 2 Gy/fraction


Locations(6)

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

View Full Details on ClinicalTrials.gov

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NCT04992780