Astra Zeneca (Immuno Stereotactic Ablative Body Radiotherapy) ISABR Study: Randomized Phase I/II Study of Stereotactic Body Radiotherapy

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT03148327
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Durvalumab (MEDI 4736) — DRUG
    Early studies has shown to possibly reduce the growth of certain types of lung cancer
  • Radiotherapy — RADIATION
    Stereotactic Body Radiation Therapy (SABR)

Study Details

This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105 subjects into the study. After an initial safety sample of 15 individuals receiving durvalumab (MEDI 4736) and Stereotactic Ablative Body Radiotherapy (SABR), if it is shown to be safe to administer this combination of therapies, the next enrolled subjects will be randomized in a 1:1 fashion (each subject with a "50-50 chance" like the flip of a coin) to receive either SABR and durvalumab (MEDI 4736), or SABR alone. Once treatment is completed, all subjects will return to the University of California at Los Angeles (UCLA) for regular follow-up visits to check on their health and outcomes. At visits both prior to and after treatment special blood samples will be drawn to be studied by UCLA scientists to look into the basic science aspects of how durvalumab (MEDI 4736) and radiation work in the body. It is hoped that we will learn more about the basic safety and science of durvalumab (MEDI 4736) combined with Stereotactic Ablative Body Radiotherapy (SABR) vs. SABR alone, while extending the life and quality of life of these subjects.

Key Dates

Start date
Oct 11, 2017
Status verified
Jul 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Regimen A: Phase I
    The intervention will be looking at radiotherapy + drug Durvalumab (MEDI 4736)
  • Experimental: Regimen A: Phase II
    The intervention will be looking at radiotherapy + drug Durvalumab (MEDI 4736)
  • Active Comparator: Regimen B: Phase II
    Radiotherapy alone

Primary Outcome Measure

Phase I: The number and severity of study participants' treatment-related adverse events as assessed by CTCAE v4.0. [ Time Frame: 4 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Jonsson Comprehensieve Cancer CenterLos AngelesCalifornia90095-
University of ColoradoDenverColorado80217-3364-
New York Weill Cornell Cancer Center at Cornell UniversityNew YorkNew York10021-

Find similar trials in Los Angeles, CA

By research site
Jonsson Comprehensieve Cancer Center· Los Angeles, CAUniversity of Colorado· Denver, CONew York Weill Cornell Cancer Center at Cornell University· New York, NY

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