Recruiting
Phase 2

Hypo-fractionated IMRT vs. Standard-fractionated IMRT

Sponsor:

University of Kansas Medical Center

Code:

NCT04992780

Conditions

Non Small Cell Lung Cancer Stage

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypo-Fractionation

Standard-Fractionation

Study Details

Brief 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

Conditions

Non Small Cell Lung Cancer Stage

Study ID

NCT04992780

Start date

Feb 25, 2022

Status verified date

Dec, 2023

Completion date

Nov, 2026

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hypo-Fractionation

Participants will receive one fraction of radiation therapy a day for 5 days each week for 5 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin area under the curve (AUC) 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.

active comparator: Standard-Fractionation

Participants will receive one fraction of radiation therapy a day for 5 days each week for 6 weeks along with weekly chemotherapy with Paclitaxel 45 milligram per meter squared (mg/m2) through intravenous (IV)infusion for 1 hour followed by Carboplatin AUC 2 IV for 30 minutes for approximately 5 or 6 weeks. Once complete, participant will receive Durvalumab, 1500 mg, IV every 4 weeks for 12 months.

Interventions

Hypo-Fractionation

62.5 Gy in 25 fractions of 2.5 Gy/fraction

Standard-Fractionation

60 Gy in 30 fractions of 2 Gy/fraction

Primary outcome measure

  • Locoregional control (LRC) [ Time Frame: From enrollment for up to 7.5 years ]

Central Contacts and Locations

Central contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

Locations

The University of Kansas Cancer Center, Westwood Campus

Recruiting

Kansas City, Kansas, United States, 66205

Contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

The University of Kansas Cancer Center, Overland Park Clinic

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Clinical Trials Nurse Navigator

913-945-7552ctnursenav@kumc.edu

The University of Kansas Cancer Center, North Clinic

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Clinical Trials Nurse Navigator

913-945-7552ctnursenav@kumc.edu

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

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Clinical Trials Nurse Navigator

913-945-7552ctnursenav@kumc.edu

University of Kansas Cancer Center, North Kansas City Hospital

Recruiting

North Kansas City, Missouri, United States, 64116

Contacts

Nurse Navigator

913-945-7552ctnursenav@kumc.edu

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Dec 7, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2023-12-07.