SCION: SABR and Checkpoint Inhibition Of NSCLC — SCION  

Lung Cancer Clinical Trial

Official title: A Phase II Study of Circulating Tumor DNA Directed Consolidation Durvalumab (MEDI4736) Following Induction and Concurrent Durvalumab With SABR for Stage I NSCLC. SCION: SABR and Checkpoint Inhibition Of NSCLC

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

PURPOSE The intent of the study is to determine whether disease control in early non-small cell lung cancer (NSCLC) achieved by stereotactic ablative body radiotherapy (SABR) can be augmented locally, regionally, and distantly by safely combining it with durvalumab. Moreover, the study will assess whether patients who are likeliest to benefit from extended treatment with durvalumab can be predicted by assaying for molecular residual disease (MRD) after initial treatment using the AVENIO assay for circulating tumor DNA (ctDNA).

HYPOTHESIS Combining SABR and Durvalumab in patients with T1-2 N0 M0 NSCLC reduces the overall relapse rate at 18 months by 50% compared with historical controls treated with SABR alone, from 19.3% to 9.7%.

OBJECTIVES Primary

• To determine the overall relapse rate at 18 months in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab.

Secondary

• To determine rates of Local Relapse, Regional Nodal Relapse, Distant Relapse, and Second Primary Lung Cancer in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab.

• To determine rates of Overall Survival, Cause-Specific Survival, and Relapse Free Survival in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab

• To determine rates of pneumonitis, immune-related toxicity, adverse events, serious adverse events in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab.

• To determine the rate of MRD detection using the AVENIO ctDNA assay in patients with T1-2 N0 M0 NSCLC treated with SABR and Durvalumab.

• To compare clinical outcomes between patients with detectable versus undetectable MRD using the AVENIO ctDNA assay following treatment with SABR and Durvalumab.

• To compare clinical outcomes between patients with detectable MRD using the AVENIO ctDNA assay following treatment with SABR and Durvalumab who receive extended Durvalumab versus no further therapy.

STUDY DESIGN Subjects who meet the eligibility criteria will be candidates for enrolment. All subjects will receive one infusion of Durvalumab every 4 weeks for four cycles (4 weeks = 1 cycle), with SABR delivered concurrently with cycle 2. Subjects will be assessed at baseline using the AVENIO assay initially on tumor tissue. This will allow the subsequent evaluation for molecular residual disease (MRD) following cycle 4 to be tumor-informed, and ultrasensitive. Subjects with no detectable ctDNA at the MRD assessment will receive no further therapy. Subjects with detectable ctDNA at the MRD assessment will be randomized to receive either no further therapy or 8 additional cycles of q4w Durvalumab. Safety will be evaluated by recording the occurrence of adverse events, serious adverse events, and laboratory abnormalities, with special attention to pneumonitis and immune-related toxicity.

Future research will be enabled through the collection of biospecimens. Subjects will separately consent to the optional collection of these biospecimens. Blood samples collected for this purpose at multiple timepoints (0, 4, 12, 24 months) will be archived in a biorepository created for this study operated by the BC Cancer Tumour Tissue Repository (Victoria, BC). Stool samples collected for this purpose at multiple timepoints (0, 4, and 12 months) will be archived in the Oncomicrobiome Repository (Montreal, QC). ;

Related Conditions & MeSH terms

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

• NCT number: NCT04944173
• Study type: Interventional
• Source: University of British Columbia
• Contact: Layla Mahmud
• Phone: 416-634-8300
• Email: Layla.Mahmud@ozmosisresearch.ca
• Status: Recruiting
• Phase: Phase 2
• Start date: August 11, 2023
• Completion date: June 2027