--SuPERIOR Trial--

Sponsor
University Health Network, Toronto
Study ID
NCT06191250
Phase
PHASE2
Status
Terminated

Conditions

  • Clinical Staging T2b-3 N0-1 M0
  • Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    one dose of durvalumab (750 mg IV)
  • Non-ablative oligofractionated radiation (NORT) — RADIATION
    12 Gy of Radiation in 3 fractions

Study Details

The Window-of-Opportunity (WOO) Network is a collaboration among Ontario's doctors and scientists to conduct clinical trials in newly-diagnosed cancer patients before they have surgery with an initial focus on understanding how cancer drugs can impact the immune system. There is often a waiting period of two to six weeks between when a patient first receives a cancer diagnosis and their scheduled surgery. This period provides a unique opportunity to study tumours before they are treated, allowing scientists to explore new ways to identify cancer, measure how cancer cells respond to treatment, and understand how therapies work. WOO Network trials include drugs or treatments that already have been tested in other clinical trials or are already approved by Health Canada. The SuPERIOR trial is a WOO trial and it is designed for cohort of patients patients diagnosed with newly-diagnosed cancer patients with stage two or three non-small cell lung cancer. The patients who are enrolled in this trial will received combination of Non-ablative oligofractionated radiation (NORT) which is a low dose of radiation and one dose of Durvalumab, an immunotherapy drug before their surgery.

Key Dates

Start date
Sep 28, 2024
Status verified
Jan 2025
Primary completion
Dec 30, 2024
Completion
Dec 30, 2024

Study Design

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

Arms

  • Experimental: Neoadjuvant NORT-durvalumab
    administration of non-ablative oligofractionated radiation therapy using 12 Gy in 3 fractions in combination with one dose of durvalumab (750 mg IV) prior to surgery.

Primary Outcome Measure

Measuring CD8 TILs density post NORT-durvalumab [ Time Frame: 17 days ]

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