Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736) — ASTEROID  

NSCLC, Stage I Clinical Trial

Official title: Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736). An Open Label Randomized Phase II Trial With Durvalumab Following Stereotactic Body Radiotherapy (SBRT) in Patients With Stage I Non-small Cell Lung Cancer (NSCLC)

Status Recruiting

Clinical Trial Summary

This is a randomized multicentre open label phase II study of Durvalumab following Stereotactic Body Radiotherapy (SBRT) in patients with T1-2N0M0 NSCLC.

Patients will be randomized 1:1 to follow up or receiving Durvalumab every 4th week for 12 months

Clinical Trial Description

This is a randomized multicentre open label phase II study of the PDL1 inhibitor Durvalumab following SBRT in patients with T1-2N0M0 NSCLC. It will enroll 106 patients aiming at a minimum of 5 subjects per site. The subjects will be randomized in a 1:1 fashion with performance status, gender and T-stage as stratification factors. Patients with peripheral lung tumors will receive SBRT usually between 3 and 4 fractions. The group randomized to immunotherapy will then receive Durvalumab, given with a fixed dose of 1500 mg i.v. every fourth week during 12 months. Both arms will be assessed according to the same follow-up schedule with radiology every third month. ;

Related Conditions & MeSH terms

• NSCLC, Stage I

• NCT number: NCT03446547
• Study type: Interventional
• Source: Vastra Gotaland Region
• Contact: Andreas Hallqvist, PhD
• Phone: +46-31342
• Email: andreas.hallqvist@vgregion.se
• Status: Recruiting
• Phase: Phase 2
• Start date: December 4, 2017
• Completion date: July 2024