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

Who is this study for? Patients with stage 2A/B non-small cell lung cancer
What treatments are being studied? Hypo-Fractionation
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Kansas
The University of Kansas Cancer Center, Westwood Campus
RECRUITING
Kansas City
The University of Kansas Cancer Center, Overland Park Clinic
RECRUITING
Overland Park
KUCC MCA- TUKHS, Saint Francis Hospital
NOT_YET_RECRUITING
Topeka
Missouri
The University of Kansas Cancer Center, North Clinic
RECRUITING
Kansas City
The University of Kansas Cancer Center, Lee's Summit Clinic
RECRUITING
Lee's Summit
University of Kansas Cancer Center, North Kansas City Hospital
RECRUITING
North Kansas City
Contact Information
Primary
KUCC Navigation
kucc_navigation@kumc.edu
913-588-3671
Time Frame
Start Date: 2022-02-25
Estimated Completion Date: 2026-11
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov