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

NCT04992780 | Recruiting Phase 2 DMC FDA Device

• 1 other identifier: IIT-2021-LU-HypoIMRT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Locoregional control (LRC)

  RECIST 1.1

  From enrollment for up to 7.5 years

Secondary Outcomes (6)

• Acute toxicities

  From enrollment for up to 7.5 years

• Late toxicities

  From enrollment for up to 7.5 years

• Progression free survival (PFS)

  From enrollment for up to 7.5 years

• Overall survival (OS)

  From enrollment for up to 7.5 years

• Measuring the Impact of Treatment on the Quality of life (QOL)

  From enrollment for up to 7.5 years

Study Arms (2)

Hypo-Fractionation

EXPERIMENTAL

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.

Radiation: Hypo-Fractionation

Standard-Fractionation

ACTIVE COMPARATOR

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.

Radiation: Standard-Fractionation

Interventions

Hypo-Fractionation RADIATION

62.5 Gy in 25 fractions of 2.5 Gy/fraction

Hypo-Fractionation

Standard-Fractionation RADIATION

60 Gy in 30 fractions of 2 Gy/fraction

Standard-Fractionation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (6)

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, 66205, United States

RECRUITING

The University of Kansas Cancer Center, Overland Park Clinic

Overland Park, Kansas, 66210, United States

RECRUITING

KUCC MCA- TUKHS, Saint Francis Hospital

Topeka, Kansas, 66606, United States

NOT YET RECRUITING

The University of Kansas Cancer Center, North Clinic

Kansas City, Missouri, 64154, United States

RECRUITING

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

Lee's Summit, Missouri, 64064, United States

RECRUITING

University of Kansas Cancer Center, North Kansas City Hospital

North Kansas City, Missouri, 64116, United States

RECRUITING

Study Officials

• Krishna Reddy, MD, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KUCC Navigation

CONTACT

913-588-3671; kucc_navigation@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: August 5, 2021
• Study Start: February 25, 2022
• Primary Completion: October 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

US (6)