Carcinoma, Non-Small-Cell LungPhase 3PACIFIC-4NCT03833154

Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

A Phase 3 study testing Durvalumab and (Osimertinib cohort, single-arm, open-label separate cohort) in people with Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 209 sites in 20 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Carcinoma, Non-Small-Cell Lung
What is being tested?: Durvalumab and (Osimertinib cohort, single-arm, open-label separate cohort)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 724 participants
Where: 209 sitesin 20 countries
Study dates: 6 Mar 2019to 31 Oct 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Main Cohort Key Inclusion Criteria:

Age ≥18 years
Planned SoC SBRT as definitive treatment
World Health Organization (WHO)/ECOG PS of 0, 1 or 2
Life expectancy of at least 12 weeks
Body weight >30 kg
Submission of tumor tissue sample if available
Adequate organ and marrow function required
Patients with central or peripheral lesions are eligible
Staging studies must be done during screening (PET-CT within 10 weeks)
Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions

Main Cohort Key Exclusion Criteria:

Mixed small cell and non-small cell cancer
History of allogeneic organ transplantation
History of another primary malignancy with exceptions
History of active primary immunodeficiency
Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
Prior exposure to immune-mediated therapy with exceptions

Osimertinib Cohort Key Inclusion Criteria

Age ≥18 years
Planned SoC SBRT as definitive treatment
WHO/ECOG PS of 0, 1, or 2
Patients with central or peripheral lesions are eligible
Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
Staging studies must be done during screening (PET-CT within 10 weeks)
Submission of tumor tissue sample if available
Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
Adequate bone marrow reserve or organ function required
Female patients should be using highly effective contraceptive measures
Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation

Osimertinib Cohort Key Exclusion Criteria

Mixed small cell and non-small cell cancer
Patients with known or increased risk factor for QTc prolongation
Treatment with any of the following:

Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
Prior treatment with neoadjuvant or adjuvant EGFR TKI
Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4

Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
Any of the following cardiac criteria

Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD

Trial locations and contacts

209 sites in 20 countries.

Country

City, postcode or hospital

209 sites in 20 countries

United States80 sites

Research Site
Akron, Ohio, 44304
Research Site
Albany, New York, 12206
Research Site
Ann Arbor, Michigan, 48197
Research Site
Annapolis, Maryland, 21401
Research Site
Atlanta, Georgia, 30322
Research Site
Atlanta, Georgia, 30342
Research Site
Austin, Texas, 78745
Research Site
Baltimore, Maryland, 21201
Research Site
Bay Pines, Florida, 33744
Research Site
Bellingham, Washington, 98225
Research Site
Blue Ash, Ohio, 45242
Research Site
Boston, Massachusetts, 02215
Research Site
Burlington, Vermont, 05401
Research Site
Camden, New Jersey, 08103
Research Site
Cedar Rapids, Iowa, 52403
Research Site
Chandler, Arizona, 85224
Research Site
Charleston, South Carolina, 29425
Research Site
Chicago, Illinois, 60611
Research Site
Chicago, Illinois, 60612
Research Site
Chicago, Illinois, 60637
Research Site
Cincinnati, Ohio, 45219
Research Site
Cleveland, Ohio, 44106
Research Site
Dallas, Texas, 75235
Research Site
Decatur, Illinois, 62526
Research Site
Detroit, Michigan, 48201
Research Site
Duarte, California, 91010
Research Site
Duluth, Minnesota, 55805
Research Site
East Syracuse, New York, 13057
Research Site
Elizabethtown, Kentucky, 42701
Research Site
Elmhurst, Illinois, 60126
Research Site
Fort Wayne, Indiana, 46845
Research Site
Grand Forks, North Dakota, 58201
Research Site
Houston, Texas, 77030
Research Site
Iowa City, Iowa, 52242
Research Site
Jacksonville, Florida, 32256
Research Site
Las Vegas, Nevada, 89169
Research Site
Lebanon, New Hampshire, 03756
Research Site
Lexington, Kentucky, 40503
Research Site
Long Beach, California, 90806
Research Site
Los Angeles, California, 90095
Research Site
Louisville, Kentucky, 40202
Research Site
Metairie, Louisiana, 70006
Research Site
Miami Beach, Florida, 33140
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Naperville, Illinois, 60540
Research Site
New Hyde Park, New York, 11042
Research Site
New Orleans, Louisiana, 70121
Research Site
New York, New York, 10016
Research Site
Newark, Delaware, 10709
Research Site
Omaha, Nebraska, 68105
Research Site
Orlando, Florida, 32804
Research Site
Paramus, New Jersey, 07652
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Phoenix, Arizona, 85004
Research Site
Pittsburgh, Pennsylvania, 15212
Research Site
Portland, Oregon, 97210
Research Site
Portland, Oregon, 97213
Research Site
Richmond, Virginia, 23249
Research Site
Rochester, Minnesota, 55905
Research Site
Rochester, New York, 14642
Research Site
Rosedale, Maryland, 21237
Research Site
Royal Oak, Michigan, 48073
Research Site
San Diego, California, 92123
Research Site
Seattle, Washington, 98195
Research Site
Sherman, Texas, 75090
Research Site
Silver Spring, Maryland, 20910
Research Site
Sioux Falls, South Dakota, 57105
Research Site
South Portland, Maine, 04106
Research Site
Spokane Valley, Washington, 99216
Research Site
St Louis, Missouri, 63110
Research Site
Stony Brook, New York, 11794
Research Site
Syracuse, New York, 13210
Research Site
The Bronx, New York, 10461
Research Site
The Bronx, New York, 10467
Research Site
Towson, Maryland, 21204
Research Site
Tucson, Arizona, 85719
Research Site
Tuscaloosa, Alabama, 35401
Research Site
Washington D.C., District of Columbia, 20010
Research Site
Watertown, South Dakota, 57201
Research Site
Winston-Salem, North Carolina, 27157

Other trials in United States

China21 sites

Research Site
Beijing, 100021
Research Site
Beijing, 100142
Research Site
Changchun, 130021
Research Site
Changsha, 410013
Research Site
Chengdu, 610042
Research Site
Fuzhou, 350005
Research Site
Hangzhou, 310002
Research Site
Hangzhou, 310022
Research Site
Hefei, 230031
Research Site
Jinan, 250117
Research Site
Nanjing, 210009
Research Site
Shanghai, 200002
Research Site
Shanghai, 200030
Research Site
Shanghai, 200032
Research Site
Shanghai, 200433
Research Site
Shenyang, 100003
Research Site
Suzhou, 215006
Research Site
Wenzhou, 325000
Research Site
Wuhan, 430022
Research Site
Wuhan, 430030
Research Site
Zhengzhou, 450008

Other trials in China

Japan14 sites

Research Site
Akashi-shi, 673-8558
Research Site
Bunkyō City, 113-8677
Research Site
Chūōku, 104-0045
Research Site
Fukuoka, 812-8582
Research Site
Hirosaki-shi, 036-8563
Research Site
Hiroshima, 734-8551
Research Site
Kobe, 650-0047
Research Site
Niigata, 951-8566
Research Site
Osaka, 541-8567
Research Site
Sakaishi, 591-8555
Research Site
Sapporo, 060-8648
Research Site
Sunto-gun, 411-8777
Research Site
Toyoake-shi, 470-1192
Research Site
Yokohama, 241-8515

Other trials in Japan

Spain13 sites

Research Site
Badajoz, 6006
Research Site
Barcelona, 08041
Research Site
L'Hospitalet de Llobregat, 08907
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Málaga, 29010
Research Site
San Sebastián, 20014
Research Site
Santiago de Compostela, 15706
Research Site
Seville, 41013
Research Site
Valencia, 46010
Research Site
Zaragoza, 50009

Other trials in Spain

Germany8 sites

Research Site
Dresden, 01307
Research Site
Göttingen, 37075
Research Site
Halle, 06120
Research Site
Hanover, 30459
Research Site
Heidelberg, 69126
Research Site
Homburg, 66424
Research Site
Regensburg, 93053
Research Site
Trier, 54292

Other trials in Germany

Italy8 sites

Research Site
Florence, 50134
Research Site
Genova, 16132
Research Site
Milan, 20132
Research Site
Orbassano, 10043
Research Site
Padova, 35128
Research Site
Pavia, 27100
Research Site
Roma, 00128
Research Site
Rozzano, 20089

Other trials in Italy

France7 sites

Research Site
Bron, 69677
Research Site
Dijon, 21079
Research Site
Lyon, 69317
Research Site
Nantes, 44202
Research Site
Pierre-Bénite, 69310
Research Site
Toulouse, 31000
Research Site
Villejuif, 94805

Other trials in France

Russia7 sites

Research Site
Kazan, Tatarstan, 420029
Research Site
Moscow, 105229
Research Site
Moscow, 115478
Research Site
Moscow, 119421
Research Site
Saint Petersburg, 197758
Research Site
Ufa, 450054
Research Site
Yekaterinburg, 620905

Other trials in Russia

Brazil6 sites

Research Site
Barretos, 14784-400
Research Site
Porto Alegre, 90110-270
Research Site
Recife, 52010-075
Research Site
Rio de Janeiro, 22271-110
Research Site
São Paulo, 01327-001
Research Site
Volta Redonda, 27258-000

Other trials in Brazil

Israel6 sites

Research Site
Haifa, 31096
Research Site
Jerusalem, 91120
Research Site
Kfar Saba, 95847
Research Site
Petah Tikva, 49100
Research Site
Ramat Gan, 52621
Research Site
Tel Aviv, 64239

Other trials in Israel

Poland6 sites

Research Site
Bydgoszcz, 85-796
Research Site
Elblag, 02-300
Research Site
Gdansk, 80-952
Research Site
Katowice, 40-514
Research Site
Lodz, 93-513
Research Site
Warsaw, 02-781

Other trials in Poland

South Korea6 sites

Research Site
Cheongju-si, 28644
Research Site
Goyang-si, 10408
Research Site
Gyeonggi-do, 13620
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351

Other trials in South Korea

Belgium5 sites

Research Site
Aalst, 9300
Research Site
Charleroi, 6060
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Leuven, 3000

Other trials in Belgium

Canada5 sites

Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
London, Ontario, N6A 5W9
Research Site
Montreal, Quebec, H2X 3E4
Research Site
Toronto, Ontario, M4N 3M5
Research Site
Toronto, Ontario, M5G 2M9

Other trials in Canada

Turkey (Türkiye)5 sites

Research Site
Ankara, 06010
Research Site
Ankara, 06520
Research Site
Istanbul, 34214
Research Site
Izmir, 35340
Research Site
Kocaeli, 41400

Other trials in Turkey (Türkiye)

United Kingdom4 sites

Research Site
Birmingham, B9 5SS
Research Site
Leeds, LS9 7TF
Research Site
London, EC1A 7BE
Research Site
Manchester, M20 4BX

Other trials in United Kingdom

Greece3 sites

Research Site
Athens, 11526
Research Site
Athens, 11527
Research Site
Thessaloniki, 55236

Other trials in Greece

Netherlands3 sites

Research Site
Amsterdam, 1081 HV
Research Site
Groningen, 9713 GZ
Research Site
Utrecht, 3584 CX

Other trials in Netherlands

Australia1 site

Research Site
Clayton, 3168

Other trials in Australia

Puerto Rico1 site

Research Site
Hato Rey, 00917

Other trials in Puerto Rico

About this study

Official title: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

Read the detailed description

Patients with Stage I/II lymph node negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to receive either Durvalumab + SoC SBRT or placebo + SoC SBRT.

The primary objective of main cohort is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS. Key secondary is to assess the efficacy of Durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of Overall Survival (OS).

In addition, a study cohort with a sufficient number of patients harboring an EGFR-TKI sensitizing mutation, will receive Osimertinib treatment after completion of SoC SBRT as definitive treatment of Stage I/II lymph node-negative NSCLC. The primary objective of Osimertinib cohort is to assess efficacy of Osimertinib following SoC SBRT in terms of 4-year PFS. Key secondary objectives include safety, OS and efficacy of Osimertininb treatment with SBRT.

Conditions: Carcinoma, Non-Small-Cell Lung
Being tested: Durvalumab, Placebo, (Osimertinib cohort, single-arm, open-label separate cohort)
Keywords: NSCLC, Early-Stage NSCLC, Lung cancer, Double- Blind, PD-L1, MEDI4736, Durvalumab, Osimertinib, PFS, OS, Unresected lung cancer, Medically Inoperable, Operable with Patient refusal, SBRT, SABR, EGFR
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DurvalumabDrug
Also called MEDI4736
Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.
PlaceboOther
Matching placebo for infusion every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
(Osimertinib cohort, single-arm, open-label separate cohort)Drug
Osimertinib 80 mg every day [qd] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT

Study groups in NCT03833154
Study group	Role	What they receive
SoC SBRT + Durvalumab Therapy (Main Cohort)	Experimental	SBRT Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met. Receives: Drug: Durvalumab
SoC SBRT + Placebo Therapy (Main Cohort)	Placebo comparator	SBRT Placebo (matching placebo for infusion) every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met. Receives: Other: Placebo
SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort)	Experimental	SBRT Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT Receives: Drug: (Osimertinib cohort, single-arm, open-label separate cohort)

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
Main Cohort
Measured: from randomization up to 6 years
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
Osimertinib Cohort
Measured: from treatment start up to 5 years

Secondary outcomes (19)

Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC
Main Cohort
Measured: from randomization up to 6 years
Overall Survival (OS)
Main Cohort
Measured: from randomization up to 7 years
Concentration of durvalumab in serum such as peak concentration and trough
Main Cohort
Measured: 12 weeks after last dose
Detection of ADA neutralising antibodies titers
Main Cohort
Measured: up to 6 months after last dose
Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30
Main Cohort
Measured: from randomization up to 7 years
Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1
Main Cohort
Measured: at 24 months following randomization
Time to progression (TTP) assessed by BICR according to RECIST 1.1
Main Cohort
Measured: from randomization up to 6 years
Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1
Main Cohort
Measured: from randomization up to 6 years
Time from randomisation to second progression (PFS2) as defined by local standard clinical practice
Main Cohort
Measured: from randomization up to 7 years
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT
Main Cohort
Measured: up to 3 months after last dose
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy
Osimertinib Cohort
Measured: Up to 35 days after last dose
WHO performance status
Osimertinib Cohort
Measured: from treatment start up to 5 years
ECG QT interval
Osimertinib Cohort
Measured: Up to 156 weeks of treatment or treatment discontinuation
Overall Survival
Osimertinib Cohort
Measured: from treatment start up to 5 years
Time To Progression (TTP)
Osimertinib Cohort
Measured: from treatment start up to 5 years
Time to CNS progression
Osimertinib Cohort
Measured: from treatment start up to 5 years
PFS2
Osimertinib Cohort
Measured: from treatment start up to 5 years
Site(s) of disease progression
Osimertinib Cohort
Measured: from treatment start up to 5 years
PFS by ICR using RECIST 1.1
Osimertinib Cohort
Measured: from treatment start up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 201931 Oct 2028

First posted6 Feb 2019
Study start6 Mar 2019
Primary completion31 Oct 2028 (estimated)
Study completion31 Oct 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 724 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03833154
Sponsor's protocol ID: D9103C00001
Other IDs: 2018-002572-41, 2018
Acronym: PACIFIC-4
Status last verified: Jul 2026
First submitted: 25 Jan 2019
Last updated: 20 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation
ClinicalTrials.gov ID: NCT03833154
Acronym / sponsor ID: PACIFIC-4 / D9103C00001
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: NSCLC, Early-Stage NSCLC, Lung cancer, Double- Blind, PD-L1, MEDI4736, Durvalumab, Osimertinib
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 724 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 6 Mar 2019 (actual)
Primary completion: 31 Oct 2028 (estimated)
Study completion: 31 Oct 2028 (estimated)
First posted: 6 Feb 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.

Detailed description

Patients with Stage I/II lymph node negative NSCLC and confirmed to meet all eligibility criteria will be randomized 1:1 to receive either Durvalumab + SoC SBRT or placebo + SoC SBRT.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
SoC SBRT + Durvalumab Therapy (Main Cohort)	Experimental	Drug: DurvalumabSBRT Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.
SoC SBRT + Placebo Therapy (Main Cohort)	Placebo comparator	Other: PlaceboSBRT Placebo (matching placebo for infusion) every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort)	Experimental	Drug: (Osimertinib cohort, single-arm, open-label separate cohort)SBRT Osimertinib 80mg every day [qd] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DurvalumabAlso: MEDI4736Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 26 cycles or until progression or other discontinuation criteria are met.	Drug	SoC SBRT + Durvalumab Therapy (Main Cohort)
PlaceboMatching placebo for infusion every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.	Other	SoC SBRT + Placebo Therapy (Main Cohort)
(Osimertinib cohort, single-arm, open-label separate cohort)Osimertinib 80 mg every day [qd] orally for up to 36 months or until progression or other discontinuation criteria are met. Osimertinib treatment should start from 7 to 14 days after completion of SBRT	Drug	SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort)

Primary outcome

Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
Time frame: from randomization up to 6 years
Main Cohort
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
Time frame: from treatment start up to 5 years
Osimertinib Cohort

19 secondary outcomes

Progression-Free Survival (PFS) assessed by BICR per RECIST 1.1 in all randomised patients with Stage I/II NSCLC
Time frame: from randomization up to 6 years
Overall Survival (OS)
Time frame: from randomization up to 7 years
Concentration of durvalumab in serum such as peak concentration and trough
Time frame: 12 weeks after last dose
Detection of ADA neutralising antibodies titers
Time frame: up to 6 months after last dose
Health-related quality of life in patients treated with durvalumab with SoC SBRT compared to placebo with SoC SBRT using the EORTC QLQ-C30
Time frame: from randomization up to 7 years
Proportion of patients alive and progression free at 24 months from randomisation (PFS24) assessed by BICR according to RECIST 1.1
Time frame: at 24 months following randomization
Time to progression (TTP) assessed by BICR according to RECIST 1.1
Time frame: from randomization up to 6 years
Time to death or distant metastasis (TTDM) assessed by BICR according to RECIST 1.1
Time frame: from randomization up to 6 years
Time from randomisation to second progression (PFS2) as defined by local standard clinical practice
Time frame: from randomization up to 7 years
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT
Time frame: up to 3 months after last dose
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy
Time frame: Up to 35 days after last dose
WHO performance status
Time frame: from treatment start up to 5 years
ECG QT interval
Time frame: Up to 156 weeks of treatment or treatment discontinuation
Overall Survival
Time frame: from treatment start up to 5 years
Time To Progression (TTP)
Time frame: from treatment start up to 5 years
Time to CNS progression
Time frame: from treatment start up to 5 years
PFS2
Time frame: from treatment start up to 5 years
Site(s) of disease progression
Time frame: from treatment start up to 5 years
PFS by ICR using RECIST 1.1
Time frame: from treatment start up to 5 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
Lung Cancer Study Locator details (for US)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

209 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab and (Osimertinib cohort, single-arm, open-label separate cohort) in people with Carcinoma, Non-Small-Cell Lung, run by AstraZeneca at 209 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 209 sites in United States, China, Japan, Spain, Germany and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC (time frame: from randomization up to 6 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03833154.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.