Safety & Efficacy of Consolidative Hypofractionated Radiation Therapy for Boosting Residual Lung Cancer With Durvalumab

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT04748419
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • consolidative hypofractionated radiation therapy (hfRT) — RADIATION
    Consolidative hfRT will start from 6.5Gy x 2 fractions and dose escalate to 10Gy x 2 fractions in a 3+3 design
  • Durvalumab 50 MG/ML — DRUG
    Durvalumab 10 mg/kg via a 60-minute iv infusion every two weeks ± 3 days for up to 12 months

Study Details

This study is designed to determine if combining consolidative radiation therapy (RT) using a hypofractionated regimen (hfRT) (2 fractions) for boosting the residual primary lung cancer with adjuvant anti-PD-L1 therapy concurrently is safe and will provide better tumor control locoregionally and distantly than either modality alone.

Key Dates

Start date
Jul 15, 2021
Status verified
Nov 2025
Primary completion
Sep 26, 2025
Completion
Sep 26, 2025

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hypofractionated radiation therapy (hfRT) with Durvalumab
    Combining consolidative radiation therapy (RT) using a hypofractionated regimen (hfRT) of 10Gy x 2 fractions for boosting the residual primary lung cancer with adjuvant anti-PD-L1 therapy (durvalumab), dose of 10 mg/kg infusion every two weeks concurrently for up to 12 months or disease progression.

Primary Outcome Measure

Evaluate the safety of combining hfRT and durvalumab by Adverse event assessed [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198-

Find similar trials in Omaha, NE

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Nebraska Medical Center· Omaha, NE

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