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Recruiting NCT04992780

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

Phase II Interventional Non Small Cell Lung Cancer Stage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hypo-Fractionation, Standard-Fractionation.
Who it may be relevant to
Registry conditions: Non Small Cell Lung Cancer Stage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Radiation Hypo-Fractionation
    62.5 Gy in 25 fractions of 2.5 Gy/fraction
  • Radiation Standard-Fractionation
    60 Gy in 30 fractions of 2 Gy/fraction

Primary outcome measures

  • Locoregional control (LRC) [Time frame: From enrollment for up to 7.5 years]
Secondary outcome measures (6)
  • Acute toxicities [Time frame: From enrollment for up to 7.5 years]
  • Late toxicities [Time frame: From enrollment for up to 7.5 years]
  • Progression free survival (PFS) [Time frame: From enrollment for up to 7.5 years]
  • Overall survival (OS) [Time frame: From enrollment for up to 7.5 years]
  • Measuring the Impact of Treatment on the Quality of life (QOL) [Time frame: From enrollment for up to 7.5 years]
  • Measuring the Impact of Treatment on the Quality of life (QOL) [Time frame: From enrollment for up to 7.5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • The University of Kansas Cancer Center, Westwood Campus — Kansas City
  • The University of Kansas Cancer Center, Overland Park Clinic — Overland Park
  • KUCC MCA- TUKHS, Saint Francis Hospital — Topeka
  • The University of Kansas Cancer Center, North Clinic — Kansas City
  • The University of Kansas Cancer Center, Lee's Summit Clinic — Lee's Summit
  • University of Kansas Cancer Center, North Kansas City Hospital — North Kansas City

Identifiers

NCT: NCT04992780 · IIT-2021-LU-HypoIMRT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗