Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736)

Sponsor
Vastra Gotaland Region
Study ID
NCT03446547
Phase
PHASE2
Status
Completed

Conditions

  • NSCLC, Stage I

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    durvalumab 1500 mg i.v. every fourth week for 12 months

Study Details

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

Key Dates

Start date
Dec 4, 2017
Status verified
Apr 2026
Primary completion
Oct 1, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
106 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Arm A
    SBRT and follow-up
  • Experimental: Arm B
    SBRT followed by Durvalumab

Primary Outcome Measure

TTP [ Time Frame: From date of randomization until the date of first documented progression, assessed up to 60 months ]

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