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SCION: SABR and Checkpoint Inhibition of NSCLC

NCT04944173 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-09-03

No results posted yet for this study

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.

Conditions

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Non-small Cell Lung Cancer Stage I
  • Lung Cancer
  • Lung Cancer Stage I
  • Lung Adenocarcinoma, Stage I
  • Lung Squamous Cell Carcinoma Stage I

Interventions

DRUG

Durvalumab

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.

RADIATION

Stereotactic Body Radiotherapy

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.

DIAGNOSTIC_TEST

Circulating Tumor DNA assay

After four cycles of durvalumab, subjects will be evaluated at the MRD Landmark for residual ctDNA to determine subsequent treatment assignment.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Ozmosis Research Inc.

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Islam Mohamed, MD · BC Cancer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-11
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04944173 on ClinicalTrials.gov