Clinical trial NCT04992780: Comparing Hypo-fractionated Intensity- Modulated Radiation Therapy to Standard- Fractionated IMRT Along With Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer Stage
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Locoregional control (LRC)
timeFrame: From enrollment for up to 7.5 years
Secondary outcomes:
measure: Acute toxicities
timeFrame: From enrollment for up to 7.5 years
measure: Late toxicities
timeFrame: From enrollment for up to 7.5 years
measure: Progression free survival (PFS)
timeFrame: From enrollment for up to 7.5 years
measure: Overall survival (OS)
timeFrame: From enrollment for up to 7.5 years
measure: Measuring the Impact of Treatment on the Quality of life (QOL)
timeFrame: From enrollment for up to 7.5 years
measure: Measuring the Impact of Treatment on the Quality of life (QOL)
timeFrame: From enrollment for up to 7.5 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, Westwood Campus
state: Kansas
city: Overland Park
country: United States
facility: The University of Kansas Cancer Center, Overland Park Clinic
state: Kansas
city: Topeka
country: United States
facility: KUCC MCA- TUKHS, Saint Francis Hospital
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, North Clinic
state: Missouri
city: Lee's Summit
country: United States
facility: The University of Kansas Cancer Center, Lee's Summit Clinic
state: Missouri
city: North Kansas City
country: United States
facility: University of Kansas Cancer Center, North Kansas City Hospital
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Krishna Reddy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: