2022 World Conference on Lung Cancer (Posters)-P1.05-01. Phase II Study of ctDNA Directed Consolidation Durvalumab After Induction and Concurrent Durvalumab with SABR for Stage I NSCLC

P1.05-01. Phase II Study of ctDNA Directed Consolidation Durvalumab After Induction and Concurrent Durvalumab with SABR for Stage I NSCLC

Back to course

Pdf Summary

This document describes a phase II clinical trial called SCION, which aims to investigate the effectiveness of combining stereotactic ablative radiation (SABR) and durvalumab, a checkpoint inhibitor, in patients with stage I non-small cell lung cancer (NSCLC). The trial focuses on patients with T1-2 N0 M0 NSCLC who are medically inoperable or decline surgery. The primary objective of the study is to determine the overall relapse rate at 18 months.<br /><br />The rationale behind the trial is based on the fact that SABR alone provides limited control of NSCLC, with high rates of relapse. Additionally, SABR has been found to induce mixed immunologic effects, potentially priming anti-tumor immunity. Checkpoint inhibitors alone have shown activity in early NSCLC, and their combination with SABR has shown an abscopal response in some cases. Furthermore, checkpoint inhibitors have been shown to reduce distant relapse after curative therapy.<br /><br />The trial design involves administering durvalumab in four cycles concurrently with SABR at cycle 2. Following initial therapy, patients undergo a circulating tumor DNA (ctDNA) assay. If the assay is negative for minimal residual disease (MRD), no further therapy is given. If MRD is detected, patients are randomized to receive either no further therapy or an additional 8 cycles of durvalumab.<br /><br />The trial will assess various secondary objectives, including rates of local relapse, regional nodal relapse, distant relapse, and second primary lung cancer, as well as overall survival, cause-specific survival, and relapse-free survival. Adverse events and toxicity will also be monitored. The AVENIO ctDNA assay, which is highly sensitive, will be used to detect MRD in patients.<br /><br />The trial is currently in the preparing for activation phase, with funding and study drug provided by AstraZeneca. Roche Sequencing will provide ctDNA assay services, and Ozmosis Research will facilitate the clinical research. Participating centers include BC Cancer and Juravinski Cancer Centre, and the trial is expected to begin in Q3 2022.<br /><br />Overall, this trial aims to assess the potential benefits of combining SABR and durvalumab in patients with stage I NSCLC and explore the use of ctDNA as a biomarker for treatment response.

Asset Subtitle

Islam Mohamed, Canada

Meta Tag

Speaker Islam Mohamed, Canada

Topic Early Stage Non-small Cell - Biomarkers

Keywords

SCION

SABR

durvalumab

NSCLC

relapse rate

ctDNA assay

MRD

secondary objectives

adverse events

biomarker