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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 7, 2023 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Oct 2023 to Oct 2025 Completion date: Nov 2024 to Nov 2026 · Study sites revised (6)v5 Show 2 more changesShow less
    • Completion date: Nov 2024 to Nov 2026
    • Study sites revised (6)

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Oct 2022 to Oct 2023 · Completion date: Nov 2023 to Nov 2024 · Start date changed from estimate of Aug 2022 to Feb 25, 2022 · 1 morev4 Show 4 more changesShow less
    • Primary completion date: Oct 2022 to Oct 2023
    • Completion date: Nov 2023 to Nov 2024
    • Start date changed from estimate of Aug 2022 to Feb 25, 2022
    • Site details revised at 6 of 6 sites
  3. Start date: Aug 2021 to Aug 2022v3
  4. Secondary endpoints revised (6)v2 See this version in full on ClinicalTrials.gov ↗
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04992780
Lead Sponsor University of Kansas Medical Center
Conditions Non Small Cell Lung Cancer Stage
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov