RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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

Official Title

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

Quick Facts

Study Start:2022-02-25

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04992780

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

KUCC Navigation

CONTACT

913-588-3671

kucc_navigation@kumc.edu

Principal Investigator

Krishna Reddy, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Study Locations (Sites)

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205

United States

The University of Kansas Cancer Center, Overland Park Clinic

Overland Park, Kansas, 66210

United States

KUCC MCA- TUKHS, Saint Francis Hospital

Topeka, Kansas, 66606

United States

The University of Kansas Cancer Center, North Clinic

Kansas City, Missouri, 64154

United States

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

Lee's Summit, Missouri, 64064

United States

University of Kansas Cancer Center, North Kansas City Hospital

North Kansas City, Missouri, 64116

United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-25

Study Completion Date2026-11

Study Record Updates

Study Start Date2022-02-25

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

Non Small Cell Lung Cancer Stage