Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT04786093
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Stereotactic radiation therapy — RADIATION
    Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
  • Durvalumab — DRUG
    Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.

Study Details

This is a randomized Phase II study which is designed to determine the impact of stereotactic radiotherapy and durvalumab on quality-of-life and oncologic outcomes in patients with advanced non-small cell lung cancer. Durvalumab (Imfinzi) and stereotactic radiotherapy, with each fraction of radiotherapy is given every other day on a standard stereotactic ablative radiotherapy (SAbR) schedule or every four weeks on the personalized ultra-fractionated stereotactic adaptive radiotherapy (PULSAR) schedule. Subjects will be followed for a period of 2 years after completion of treatment or until death, whichever occurs first. Specifically, subjects will be followed at 1, 3, 6, 9, 12, 15, 18, 21, and 24 months following treatment. After the 2 year follow up, the patient can continue routine follow up with their physicians, per standard of care. Subjects removed from therapy for unacceptable adverse events will be followed until resolution or stabilization of the adverse event.

Key Dates

Start date
Jul 27, 2021
Status verified
Feb 2026
Primary completion
Jun 9, 2022
Completion
Jun 9, 2022

Study Design

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

Arms

  • Active Comparator: Stereotactic Ablative Radiotherapy (SAbR) Arm plus Durvalumab arm
    SAbR with each radiation treatment fraction delivered every other day
  • Experimental: Personalized Ultra-fractionated Stereotactic Radiotherapy (PULSAR) plus Durvalumab arm
    PULSAR with each radiation treatment fraction delivered every 4 weeks

Primary Outcome Measure

Quality of Life Scores [ Time Frame: 2 years post-treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Dallas, TX

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Texas Southwestern Medical Center· Dallas, TX

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