NCT03446547

Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736)

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• NSCLC, Stage I

Interventions

Type	Name	Description
DRUG	Durvalumab	durvalumab 1500 mg i.v. every fourth week for 12 months

Timeline

• Start date: 2017-12-04
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2018-02-27
• Last updated: 2026-04-14

Locations

15 sites across 3 countries: Finland, Norway, Sweden

Regulatory

• FDA-regulated drug study