Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC (NCT04786093) | Clinical Trial Compass
TerminatedPhase 2
Durvalumab and Stereotactic Radiotherapy for Advanced NSCLC
Stopped: Sponsor decision to halt funding.
United States1 participantsStarted 2021-07-27
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have biopsy-proven metastatic non-small cell lung cancer and eligible for receipt of immunotherapy, based on standard of care
✓. Patients can present with either de novo metastatic disease or recurrent disease
✓. Patients must have at least one (1) symptomatic or progressive metastatic sites with no more than 10 metastatic sites, based on standard imaging studies
✓. Patients cannot have received any prior radiation therapy or surgery to the intended radiation treatment area (index lesion)
✓. Patients with brain metastases may be enrolled if all lesions are treated with radiation therapy or surgery prior to start of protocol therapy
✓. Metastases in major lower extremity weight-bearing bones or spine should undergo surgical stabilization if indicated
✓. Age greater than or equal to 18 years.
✓. Both men and women and members of all races and ethnic groups will be included
Exclusion criteria
What they're measuring
1
Quality of Life Scores
Timeframe: 2 years post-treatment
Trial details
NCT IDNCT04786093
SponsorUniversity of Texas Southwestern Medical Center
. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
✕. Administration of two or more lines of systemic therapy for the diagnosis of metastatic non-small cell lung cancer
✕. Subjects may not be receiving any other investigational agents for the treatment of the cancer under study.
✕. Patients with untreated brain metastases
✕. Patients with progressive metastatic disease involving the skin or subcutaneous tissues, esophagus, stomach, intestines, or mesenteric lymph nodes that are felt to be too high risk to treat with radiation therapy to protocol dose.
✕. Patients cannot have pathologic fracture at the evaluated site
✕. Patients cannot have untreated spinal cord compression
✕. History of allergic reactions attributed to compounds of similar chemical or biologic composition to durvalumab or other agents used in study