Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736)

NCT03446547 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2016-005225-37
• Study Type: interventional
• Target: 106
• Locations: 3 countries
• Sites: 15

Brief 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

Conditions

NSCLC, Stage I

Keywords

SBRT; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• TTP

  Time to progression

  From date of randomization until the date of first documented progression, assessed up to 60 months

Secondary Outcomes (4)

• OS

  From date of randomization until the date of death from any cause, assessed up to 60 months

• LC

  Assessed at scheduled timepoints every 3-6 months through study completion (60 months)

• QoL

  Measured at baseline and at three timepoints (6, 12 and 20 months)

• TTP by PDL1 expression

  From date of randomization until the date of first documented progression, assessed up to 60 months

Study Arms (2)

Arm A

NO INTERVENTION

SBRT and follow-up

Arm B

EXPERIMENTAL

SBRT followed by Durvalumab

Drug: Durvalumab

Interventions

Durvalumab DRUG

durvalumab 1500 mg i.v. every fourth week for 12 months

Also known as: Medi4736

Arm B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained from the subject prior to performing any protocol- related procedures, including screening evaluations
• Histological or cytological diagnosis of NSCLC
• Stage I-IIA tumours ≤ 5 cm
• Peripheral tumours
• Medically inoperable patients or patients refusing surgery
• Received no prior chemotherapy or radiation therapy for NSCLC
• Age \> 18 years at time of study entry, no upper age limit
• WHO performance status 0-2
• Adequate normal organ and marrow function as defined below:
• Haemoglobin ≥ 9.0 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (\> 1500 per mm3)
• Platelet count ≥ 100 x 109/L (\>100,000 per mm3)
• Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
• AST/ALT ≤ 2.5 x institutional upper limit of normal
• Serum creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by chrome-EDTA or Iohexol clearance

You may not qualify if:

• Centrally located tumours
• No regional or distant metastases are allowed (i.e. no stage II-IV disease)
• Oxygen usage or a FEV1 \< 0.7 L and CO diffusion capacity \< 30%
• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). Previous enrollment in the present study
• Participation in another clinical study with an investigational product during the last 4 weeks
• Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
• Second primary residual malignancy. Other malignancy diagnosed and treated \> 5 years ago without relapse is allowed. (Carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin \< 5 years are allowed)
• Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug
• Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated from 3 electrocardiograms (ECGs) using Frediricia's Correction
• Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
• Active or prior documented autoimmune or inflammatory disorders . The following are exceptions to this criterion:
• Subjects with vitiligo or alopecia
• Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
• Any chronic skin condition that does not require systemic therapy
• Subjects without active disease in the last 5 years may be included but only after consultation with the study physician

Sponsors & Collaborators

• Vastra Gotaland Region: lead
• AstraZeneca: collaborator

Study Sites (15)

Helsinki

Helsinki, Finland

Location

Dept of Oncology

Tampere, Finland

Location

Turku

Turku, Finland

Location

Dept of Oncology

Vaasa, Finland

Location

Ålesund

Ålesund, Norway

Location

Dept of Oncology

Oslo, Norway

Location

Dept of pulmonary medicine

Tromsø, Norway

Location

Dept of Oncology

Trondheim, Norway

Location

Dept of pulmonary medicine

Gävle, Sweden

Location

Dept. of Oncology

Gothenburg, Sweden

Location

Dept of pulmonary medicine

Linköping, Sweden

Location

Sunderbyn

Luleå, Sweden

Location

Dept of pulmonary medicine

Lund, Sweden

Location

Dept of Oncology

Stockholm, Sweden

Location

Dept. of Oncology

Umeå, Sweden

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Andreas Hallqvist, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: February 27, 2018
• Study Start: December 4, 2017
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (4); NO (4); SE (7)