SCION: SABR and Checkpoint Inhibition of NSCLC

Sponsor
University of British Columbia
Study ID
NCT04944173
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Subjects will receive durvalumab 1500mg IV every four weeks for four cycles, undergo assessment for residual disease, then a subset of subjects will receive an additional eight cycles of durvalumab.
  • Stereotactic Body Radiotherapy — RADIATION
    Subjects will receive stereotactic radiation therapy concurrent with cycle 2 of durvalumab to a dose of 48Gy in four fractions. Fractionation may be modified for central tumors.
  • Circulating Tumor DNA assay — DIAGNOSTIC_TEST
    After four cycles of durvalumab, subjects will be evaluated at the MRD Landmark for residual ctDNA to determine subsequent treatment assignment.

Study Details

The SCION Trial is a clinical trial in patients with early stage non-small cell lung cancer. The purpose of the trial is to investigate whether it is safe and effective to combine standard radiation treatment with a drug called durvalumab, a type of immunotherapy. In addition, the study will use a blood test to look for cancer cell DNA to determine how long treatment with durvalumab should last. Both the use of durvalumab and the use of the blood test are new strategies for managing early stage non-small cell lung cancer.

Key Dates

Start date
Aug 11, 2023
Status verified
Aug 2024
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: MRD Negative
    All subjects will receive four cycles of durvalumab with SABR concurrent at cycle 2, then will be evaluated for MRD. Subjects in this arm have no detectable ctDNA at MRD landmark and will receive no further therapy.
  • Experimental: MRD Positive, no further therapy
    All subjects will receive four cycles of durvalumab with SABR concurrent at cycle 2, then will be evaluated for MRD. Subjects in this arm have detectable ctDNA at MRD landmark and are randomized to no further therapy.
  • Experimental: MRD Positive, consolidation durvalumab
    All subjects will receive four cycles of durvalumab with SABR concurrent at cycle 2, then will be evaluated for MRD. Subjects in this arm have detectable ctDNA at MRD landmark and are randomized to eight additional cycles of durvalumab

Primary Outcome Measure

Overall Risk of Relapse [ Time Frame: 18 months ]

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