ClinicalTrials.gg
CompletedNCT03446547ASTEROIDUpdated Apr 14, 2026

Ablative STEreotactic RadiOtherapy wIth Durvalumab (MEDI4736)

A Phase 2 interventional study of Durvalumab in NSCLC, Stage I, sponsored by Vastra Gotaland Region. Completed at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Vastra Gotaland Region · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2025, 1 year 1 month ago, and no results have been posted to the registry.

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Phase
Phase 2
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung — 16 open to participants now, 37 under way, 11 of them phase 3. durvalumab · Carcinoma, Non-Small-Cell Lung.

Enrollment
32nd of 94
106 · median 74
Started
2017
with 9 others
Phase 2
58 of 94
11 open now
Registered
29th of 94
by date

Among the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, this one is the 32nd largest by enrollment, is one of 10 that started in 2017, is one of 58 in phase 2, and was the 29th registered.

Carcinoma, Non-Small-Cell Lung

7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Open to participants now

16 of the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung are open now, in 12 countries. Recruiting first, the newest first:

11 more — sign in →

By country, each count listing its studies:

All 16 open studies →

About durvalumab

durvalumab: first FDA approval 2017 (IMFINZI), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, or all of them as a file.
02

Study 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

Read the 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.

03

Conditions studied

  • NSCLC, Stage I

Keywords

  • SBRT
  • Immunotherapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Written 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
  • 0-2
  • Adequate normal organ and marrow function as defined below:
  • ≥ 9.0 g/dL
  • (ANC) ≥ 1.5 x 109/L (> 1500 per mm3)
  • count ≥ 100 x 109/L (>100,000 per mm3)
  • Serum ≤ 1.5 x institutional (ULN)
  • /ALT ≤ 2.5 x institutional upper limit of normal
  • Serum creatinine CL>40 mL/min by the formula (Cockcroft and Gault 1976) or by chrome-EDTA or Iohexol clearance
  • Evidence of status or negative urinary or serum pregnancy test for female pre-menopausal subjects
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclusion criteria

Exclusion Criteria:

  • Centrally located tumours
  • No regional or distant are allowed (i.e. no stage II-IV disease)
  • Oxygen usage or a \< 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 product during the last 4 weeks
  • Any previous treatment with a PD1 or inhibitor, including durvalumab
  • Second primary residual . 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 corrected for heart rate (QTc) ≥470 ms calculated from 3 (ECGs) using Frediricia's Correction
  • Current or prior use of medication within 14 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
  • Active or prior documented 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
    • Subjects with celiac disease controlled by diet alone
  • History of primary immunodeficiency
  • History of allogeneic organ transplant
  • History of to durvalumab or any
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure ( III-IV), uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, cardiac arrhythmia, active peptic ulcer disease, active bleeding diatheses
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), (known positive HBV surface antigen (HBsAg) result), , or (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • Receipt of within 30 days prior to study entry or within 30 days of receiving durvalumab
  • Female subjects who are pregnant or breastfeeding or male or female subjects of who are not willing to employ effective from screening to 90 days after the last dose of durvalumab monotherapy.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results
Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (actual)

Study arms

  • No intervention
    Arm A

    SBRT and follow-up

  • Experimental
    Arm B

    SBRT followed by Durvalumab

    Drug: Durvalumab

Interventions

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

    Also known as: Medi4736

06

What researchers measure

Primary outcomes

  1. TTP

    Time to progression

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

Secondary outcomes

  1. OS

    Overall survival

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

  2. LC

    Local control

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

  3. QoL

    QoL by LCSS

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

  4. TTP by PDL1 expression

    Time to progression related to level of PDL1expression

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

07

Study locations

15 sites
  • Helsinki
    Helsinki, Finland
  • Dept of Oncology
    Tampere, Finland
  • Turku
    Turku, Finland
  • Dept of Oncology
    Vaasa, Finland
  • Ålesund
    Ålesund, Norway
  • Dept of Oncology
    Oslo, Norway
  • Dept of pulmonary medicine
    Tromsø, Norway
  • Dept of Oncology
    Trondheim, Norway
  • Dept of pulmonary medicine
    Gävle, Sweden
  • Dept. of Oncology
    Gothenburg, Sweden
  • Dept of pulmonary medicine
    Linköping, Sweden
  • Sunderbyn
    Luleå, Sweden
  • Dept of pulmonary medicine
    Lund, Sweden
  • Dept of Oncology
    Stockholm, Sweden
  • Dept. of Oncology
    Umeå, Sweden
08

References and documents

Individual participant data

Plan to share: No — Will be available later on

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Oct 2025, 93 months.

Of 730 non-industry phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 84. This study's 93 months is above that.

Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2018
First posted
Feb 27, 2018
StartActual
Dec 4, 2017
Primary completionActual
Oct 1, 2025
CompletionActual
Oct 1, 2025
Last update
Apr 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03446547
Collaborators
AstraZeneca
Responsible party
Andreas Hallqvist (Principal Investigator, Vastra Gotaland Region) — Principal investigator
First posted
Feb 27, 2018
Start date
Dec 4, 2017
Primary completion
Oct 1, 2025
Completion
Oct 1, 2025
Last update
Apr 14, 2026

Study contacts

Andreas Hallqvist, PhD
principal investigator · Göteborg University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Durvalumab

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