SCION: SABR and Checkpoint Inhibition of NSCLC (NCT04944173) | Clinical Trial Compass
WithdrawnPhase 2
SCION: SABR and Checkpoint Inhibition of NSCLC
Stopped: Overestimated pool of eligible patients and the potential participants either declined participation or did not meet eligibility criteria.
Canada0Started 2023-08-11
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must be competent, \>18yo at time of study entry, and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union \[EU\] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
✓. Patients with histological diagnosis of NSCLC, all histological sub-types are eligible
✓. Body weight \>30kg
✓. ECOG Performance status (PS) 0-2.
✓. Tumor stage T1-2 (≤5cm) N0 M0 (8th Edition of the TNM Classification for Lung Cancer) based on CT chest/abdomen, FDG-PET within 12 weeks of enrolment, and, where performed, EBUS-guided biopsy of hilar or mediastinal nodes within 8 weeks of enrolment.
✓. Subject deemed medically inoperable, or subject deemed operable but declines surgery following surgical assessment.
✓. Peripheral (outside a 2cm radius proximal bronchial tree) and central (within 2cm, but neither abuts nor invades proximal bronchial tree) tumors permitted.
. Screening laboratory values for organ function must meet the following criteria within 14 days prior to cycle 1 day 1:
Exclusion criteria
✕. Any patient with malignancy which cannot be reliably defined on the treatment planning CT scan due to adjacent opacification from effusion, consolidation, or atelectasis.
✕. History of allogenic organ transplantation.
✕. History of active primary immunodeficiency
✕. 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:
✕. Patients with vitiligo or alopecia
✕. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
✕. Any chronic skin condition that does not require systemic therapy
✕. Patients without active disease in the last 5 years may be included but only after consultation with the study physician