Non-Small Cell Lung CancerPhase 3AEGEANNCT03800134

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

A Phase 3 study testing Durvalumab, Carboplatin and Cisplatin in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 231 sites in 28 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, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response. Read more about this study

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: Durvalumab, Carboplatin and Cisplatin
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 825 participants
Where: 231 sitesin 28 countries
Study dates: 6 Dec 2018to 11 Sep 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 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18 years
Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines
Adequate organ and marrow function

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Confirmation of a patient's tumour PD-L1 status
Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy

Who cannot join

History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
History of another primary malignancy
History of active primary immunodeficiency
Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
Deemed unresectable NSCLC by multidisciplinary evaluation

Show all 13Show fewer

Patients who have pre-operative radiotherapy treatment as part of their care plan
Patients who have brain metastases or spinal cord compression
Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
Known allergy or hypersensitivity to any of the study drugs or excipients
Existence of more than one primary tumour such as mixed small cell and NSCLC histology
Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections
Patients with a documented test result confirming the presence of EGFRm or ALK translocation

Trial locations and contacts

231 sites in 28 countries.

Country

City, postcode or hospital

231 sites in 28 countries

China34 sites

Research Site
Beijing, 100021
Research Site
Beijing, 100029
Research Site
Beijing, 100191
Research Site
Beijing, 101149
Research Site
Changsha, 410008
Research Site
Changsha, 410013
Research Site
Changzhou, 213000
Research Site
Chengdu, 610041
Research Site
Guangzhou, 510095
Research Site
Guangzhou, 510515
Research Site
Guiyang, 550002
Research Site
Hangzhou, 310003
Research Site
Hangzhou, 310022
Research Site
Hangzhou, 310030
Research Site
Hangzhou, 310052
Research Site
Hefei, 230001
Research Site
Kunming, 650118
Research Site
Linhai, 317000
Research Site
Nanchang, 330006
Research Site
Ningbo, 315000
Research Site
Shanghai, 200052
Research Site
Shanghai, 200433
Research Site
Shenyang, 110042
Research Site
Shenyang, 110044
Research Site
Shenzhen, 518035
Research Site
Shenzhen, 518036
Research Site
Tianjin, 300060
Research Site
Ürümqi, 830000
Research Site
Wuhan, 430060
Research Site
Wuhan, 430079
Research Site
Xiamen, 361004
Research Site
Xintai, 54031
Research Site
Yangzhou, 225001
Research Site
Zhengzhou, 450008

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United States31 sites

Research Site
Ashland, Kentucky, 41101
Research Site
Aurora, Colorado, 80012
Research Site
Austin, Texas, 78745
Research Site
Bend, Oregon, 97701
Research Site
Boca Raton, Florida, 33486
Research Site
Charleston, South Carolina, 29414
Research Site
Charleston, South Carolina, 29424
Research Site
Chicago, Illinois, 60612
Research Site
Duarte, California, 91010
Research Site
Duluth, Minnesota, 55805
Research Site
Durham, North Carolina, 27710
Research Site
Fairfax, Virginia, 22031
Research Site
Fort Worth, Texas, 76104
Research Site
Houston, Texas, 77030
Research Site
Houston, Texas, 77090
Research Site
Jacksonville, Florida, 32256
Research Site
Kirkland, Washington, 98034
Research Site
Lexington, Kentucky, 40513
Research Site
Medford, Oregon, 97504
Research Site
Minneapolis, Minnesota, 55404
Research Site
Morristown, New Jersey, 07962
Research Site
New York, New York, 10028
Research Site
New York, New York, 10065
Research Site
Orange, California, 92868
Research Site
Phoenix, Arizona, 85054
Research Site
Pittsburgh, Pennsylvania, 15212
Research Site
Seattle, Washington, 98109
Research Site
Shirley, New York, 11967
Research Site
Silver Spring, Maryland, 20910
Research Site
Towson, Maryland, 21204
Research Site
Wichita, Kansas, 67214

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India14 sites

Research Site
Ahmedabad, 380060
Research Site
Gūrgaon, 122001
Research Site
Gūrgaon, 122002
Research Site
Kolkata, 700160
Research Site
Manipal, 576104
Research Site
Mumbai, 400012
Research Site
Mumbai, 400053
Research Site
Mysuru, 570017
Research Site
Namakkal, 637001
Research Site
Nashik, 422002
Research Site
New Delhi, 110076
Research Site
New Delhi, 110085
Research Site
Thane, 401107
Research Site
Visakhapatnam, 530017

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Japan14 sites

Research Site
Habikino-shi, 583-8588
Research Site
Himeji-shi, 670-8520
Research Site
Hiroshima, 730-8518
Research Site
Hiroshima, 734-8551
Research Site
Iwakuni-shi, 740-8510
Research Site
Kitaadachi-gun, 362-0806
Research Site
Kitakyushu-shi, 807-8555
Research Site
Kurashiki Shi, 701 0192
Research Site
Nagoya, 464-8681
Research Site
Niigata, 951-8566
Research Site
Okayama, 700-8558
Research Site
Osakasayama-shi, 589-8511
Research Site
Toyoake-shi, 470-1192
Research Site
Wakayama, 641-8510

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Brazil13 sites

Research Site
Barretos, 14784-400
Research Site
Belo Horizonte, 30380-090
Research Site
Campinas, 13060-904
Research Site
Curitiba, 81520-060
Research Site
Florianópolis, 88034-000
Research Site
Natal, 59075-740
Research Site
Porto Alegre, 90610-000
Research Site
Santa Maria, 97015-450
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 01246-000
Research Site
São Paulo, 01323-903
Research Site
Teresina, 64049-200
Research Site
Vitória, 29043-260

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Russia12 sites

Research Site
Kazan', 420029
Research Site
Krasnoyarsk, 660133
Research Site
Moscow, 105229
Research Site
Moscow, 115008
Research Site
Moscow, 115280
Research Site
Moscow, 121205
Research Site
Nizhny Novgorod, 603081
Research Site
Obninsk, 249036
Research Site
Rostov-on-Don, 344037
Research Site
Saint Petersburg, 197022
Research Site
Tomsk, 634063
Research Site
Yaroslavl, 150054

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Italy9 sites

Research Site
Ancona, 60126
Research Site
Bari, 70124
Research Site
Bergamo, 24127
Research Site
Florence, 50134
Research Site
Milan, 20132
Research Site
Monza, 20900
Research Site
Padova, 35128
Research Site
Roma, 00100
Research Site
Verona, 37126

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Argentina8 sites

Research Site
Buenos Aires, C1118AAT
Research Site
CABA, C1012AAR
Research Site
CABA, C1280AEB
Research Site
La Plata, 1900
Research Site
Pergamino, B2700CPM
Research Site
Rosario, S2000DEJ
Research Site
San Salvador de Jujuy, 4600
Research Site
Viedma, R8500ACE

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Mexico8 sites

Research Site
Aguascalientes, 20230
Research Site
Chihuahua City, 31000
Research Site
Guadalajara, 44680
Research Site
México, 1400
Research Site
México, 14050
Research Site
Monterrey, 64000
Research Site
Monterrey, 64710
Research Site
Pachuca, 42090

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Spain8 sites

Research Site
Alicante, 03010
Research Site
Barcelona, 08036
Research Site
Donostia / San Sebastian, 20014
Research Site
Madrid, 28040
Research Site
Málaga, 29010
Research Site
Oviedo, 33011
Research Site
Pamplona, 31008
Research Site
Santiago de Compostela (A Coruña), 15706

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Taiwan8 sites

Research Site
Changhua, 500
Research Site
Taichung, 402
Research Site
Taichung, 40705
Research Site
Tainan, 70403
Research Site
Tainan, 73657
Research Site
Taipei, 10002
Research Site
Taipei, 110
Research Site
Taipei, 235

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Canada7 sites

Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
Kitchener, Ontario, N2G 1G3
Research Site
Lévis, Quebec, G6V 3Z1
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Montreal, Quebec, H4J 1C5
Research Site
Québec, Quebec, G1V 4G5
Research Site
Saskatoon, Saskatchewan, S7N 4H4

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South Korea7 sites

Research Site
Busan, 48108
Research Site
Cheongju-si, 28644
Research Site
Seongnam-si, 13620
Research Site
Seoul, 05505
Research Site
Seoul, 06591
Research Site
Suwon, 16499
Research Site
Suwon, 442-723

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Thailand6 sites

Research Site
Bangkok, 10300
Research Site
Bangkok, 10330
Research Site
Chiang Mai, 50200
Research Site
Chiang Rai, 57000
Research Site
Khon Kaen, 40002
Research Site
Lampang, 52000

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Austria5 sites

Research Site
Graz, 8036
Research Site
Innsbruck, 6020
Research Site
Rankweil, 6830
Research Site
Vienna, 1090
Research Site
Vienna, 1210

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France5 sites

Research Site
Avignon, 84902
Research Site
Lyon, 69373
Research Site
Nice, 06100
Research Site
Toulon, 83800
Research Site
Vantoux, 57070

Other trials in France

Hungary5 sites

Research Site
Budapest, 1121
Research Site
Gyöngyös - Mátraháza, 3200
Research Site
Győr, 9024
Research Site
Székesfehérvár, 8000
Research Site
Törökbálint, 2045

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Peru5 sites

Research Site
Bellavista, CALLAO 2
Research Site
Lima, LIMA 11
Research Site
Lima, LIMA 31
Research Site
Lima, Lima 32
Research Site
Lima, LIMA 34

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Bulgaria4 sites

Research Site
Plovdiv, 4004
Research Site
Sofia, 1330
Research Site
Sofia, 1407
Research Site
Sofia, 1797

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Chile4 sites

Research Site
Santiago, 7500713
Research Site
Santiago, 7500921
Research Site
Temuco, 4810469
Research Site
Viña del Mar, 2540488

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Germany4 sites

Research Site
Bielefeld, 33611
Research Site
Cologne, 51109
Research Site
Frankfurt am Main, 60431
Research Site
Immenstadt im Allgäu, 87509

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Philippines4 sites

Research Site
Davao City, 8000
Research Site
Iloilo City, 5000
Research Site
Makati, 1229
Research Site
Quezon City, 1100

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Poland4 sites

Research Site
Bialystok, 15-276
Research Site
Olsztyn, 10-357
Research Site
Warsaw, 02-781
Research Site
Warsaw, 04-141

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Vietnam4 sites

Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 10000
Research Site
Ho Chi Minh City, 700000
Research Site
Ho Chi Minh City, 70000

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Belgium3 sites

Research Site
Ghent, 9000
Research Site
Liège, 4000
Research Site
Mons, 7000

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Costa Rica2 sites

Research Site
San José, 1000
Research Site
San José, 10108

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Netherlands2 sites

Research Site
Arnhem, 6815 AD
Research Site
Nijmegen, 6525 GA

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Romania1 site

Research Site
Suceava, 720237

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About this study

Official title: A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

Conditions: Non-Small Cell Lung Cancer
Being tested: Durvalumab, Placebo, Carboplatin, Cisplatin, Pemetrexed
Keywords: Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer
Medical subject headings: Carcinoma, Non-Small-Cell Lung, Carcinoma

What participants receive

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

DurvalumabDrug
Also called MEDI4736
1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
PlaceboOther
Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
CarboplatinDrug
Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles
CisplatinDrug
75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles
PemetrexedDrug
500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
PaclitaxelDrug
200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
GemcitabineDrug
1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.
SurgeryProcedure or surgery
Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.

Study groups in NCT03800134
Study group	Role	What they receive
Arm 1: Durvalumab with platinum-based chemotherapy	Experimental	Patients will receive durvalumab 1500 mg in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by durvalumab 1500 mg monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment) Receives: Drug: Durvalumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Gemcitabine; Procedure: Surgery
Arm 2: Placebo with platinum-based chemotherapy	Placebo comparator	Patients will receive placebo in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment) Receives: Other: Placebo; Drug: Carboplatin; Drug: Cisplatin; Drug: Pemetrexed; Drug: Paclitaxel; Drug: Gemcitabine; Procedure: Surgery

What is being measured

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

Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
Measured: Up to approximately 15 weeks after randomization
Event-Free Survival (EFS) in modified intent to treat (mITT) population
An event is defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.
Measured: Up to 5.5 years after first patient randomized.

Secondary outcomes (12)

Disease-free survival (DFS) in modified resected population
Measured: From date of randomization to approximately 5.5 years after date of resection
Major Pathological Response (mPR) in modified intent to treat (mITT) population
Measured: Up to approximately 15 weeks after randomization
Overall Survival (OS) in modified intent to treat (mITT) population
Measured: From date of randomization to 5.5 years after randomization
Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Measured: From date of randomization to 5.5 years after randomization
pCR in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Measured: Up to approximately 15 weeks after randomization
Disease-Free Survival (DFS) in PD-L1-TC ≥1% patients in modified resected population
Measured: From date of randomization to 5.5 years after date of resection
Major Pathological Response (mPR) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Measured: Up to approximately 15 weeks after randomization
Overall Survival (OS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Measured: From date of randomization to 5.5 years after randomization.
To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
Measured: From date of screening to 6 months after last dose of IP
To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
Measured: From date of screening to 6 months after last dose of IP
To assess the PK of durvalumab in blood
To assess concentration of durvalumab in bloodstream.
Measured: From date of randomization to 2 months after resection
Presence of ADA for durvalumab
To evaluate the presence of antibodies following treatment with study medications.
Measured: From date of randomization to 3 months after last dose of IP

Timeline

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

6 Dec 201811 Sep 2028

First posted11 Jan 2019
Study start6 Dec 2018
Primary completion10 Nov 2022
Study completion11 Sep 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Non-Small Cell Lung CancerStudies 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: Double blind
Who is masked: Participant, Care provider
Enrolment: 825 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03800134
Sponsor's protocol ID: D9106C00001
Other IDs: 2018-002997-29, 2018
Acronym: AEGEAN
Status last verified: Jun 2025
First submitted: 7 Dec 2018
Last updated: 11 Jun 2025
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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

Mitsudomi T, Heymach JV, Horio Y, Tanaka F, Tanaka H, Kuyama S, Okada M, Toyooka S, Watanabe Y, Reck M, Harpole D, Taube JM, Olivo Y, Xiong H, Fouad TM, Chen A, Akamatsu H. Perioperative Durvalumab for Resectable NSCLC: Updated Outcomes for Japanese Patients in AEGEAN. Cancer Sci. 2026 Sep 27:10.1111/cas.70541. doi: 10.1111/cas.70541. Online ahead of print.
PubMed 42802029
Mitsudomi T, Heymach JV, Reck M, Taube JM, Gao S, Horio Y, You J, Li G, Van Luong D, Saeteng S, Tanaka F, Watzka SB, Urban L, Szalai Z, Akamatsu H, Kang JH, Orlandi FJ, Mukhametshina GZ, Pircher A, Teixeira CHA, Aperghis M, Doherty GJ, Doake R, Fouad TM, Harpole D. Surgical Outcomes With Neoadjuvant Durvalumab Plus Chemotherapy Followed by Adjuvant Durvalumab in Resectable NSCLC. J Thorac Oncol. 2025 Nov;20(11):1639-1654. doi: 10.1016/j.jtho.2025.06.015. Epub 2025 Jun 20.
PubMed 40545237
Heymach JV, Harpole D, Mitsudomi T, Taube JM, Galffy G, Hochmair M, Winder T, Zukov R, Garbaos G, Gao S, Kuroda H, Ostoros G, Tran TV, You J, Lee KY, Antonuzzo L, Papai-Szekely Z, Akamatsu H, Biswas B, Spira A, Crawford J, Le HT, Aperghis M, Doherty GJ, Mann H, Fouad TM, Reck M; AEGEAN Investigators. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 2;389(18):1672-1684. doi: 10.1056/NEJMoa2304875. Epub 2023 Oct 23.
PubMed 37870974

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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)
ClinicalTrials.gov ID: NCT03800134
Acronym / sponsor ID: AEGEAN / D9106C00001
Conditions: Non-Small Cell Lung Cancer
Keywords: Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 825 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 6 Dec 2018 (actual)
Primary completion: 10 Nov 2022 (actual)
Study completion: 11 Sep 2028 (estimated)
First posted: 11 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Arm 1: Durvalumab with platinum-based chemotherapy	Experimental	Drug: Durvalumab, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Gemcitabine, Procedure: SurgeryPatients will receive durvalumab 1500 mg in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by durvalumab 1500 mg monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)
Arm 2: Placebo with platinum-based chemotherapy	Placebo comparator	Other: Placebo, Drug: Carboplatin, Drug: Cisplatin, Drug: Pemetrexed, Drug: Paclitaxel, Drug: Gemcitabine, Procedure: SurgeryPatients will receive placebo in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age ≥18 years
Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines

Key exclusion criteria (13 listed)

History of allogeneic organ transplantation
Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome)
History of another primary malignancy
History of active primary immunodeficiency
Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus

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: MEDI47361500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period	Drug	Arm 1: Durvalumab with platinum-based chemotherapy
PlaceboDay 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period	Other	Arm 2: Placebo with platinum-based chemotherapy
CarboplatinArea under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles	Drug	Arm 1: Durvalumab with platinum-based chemotherapy, Arm 2: Placebo with platinum-based chemotherapy
Cisplatin75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles	Drug	Arm 1: Durvalumab with platinum-based chemotherapy, Arm 2: Placebo with platinum-based chemotherapy
Pemetrexed500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.	Drug	Arm 1: Durvalumab with platinum-based chemotherapy, Arm 2: Placebo with platinum-based chemotherapy
Paclitaxel200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.	Drug	Arm 1: Durvalumab with platinum-based chemotherapy, Arm 2: Placebo with platinum-based chemotherapy
Gemcitabine1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.	Drug	Arm 1: Durvalumab with platinum-based chemotherapy, Arm 2: Placebo with platinum-based chemotherapy
SurgeryExpected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.	Procedure or surgery	Arm 1: Durvalumab with platinum-based chemotherapy, Arm 2: Placebo with platinum-based chemotherapy

Primary outcome

Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
Event-Free Survival (EFS) in modified intent to treat (mITT) population
Time frame: Up to 5.5 years after first patient randomized.
An event is defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.

12 secondary outcomes

Disease-free survival (DFS) in modified resected population
Time frame: From date of randomization to approximately 5.5 years after date of resection
Major Pathological Response (mPR) in modified intent to treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Overall Survival (OS) in modified intent to treat (mITT) population
Time frame: From date of randomization to 5.5 years after randomization
Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: From date of randomization to 5.5 years after randomization
pCR in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Disease-Free Survival (DFS) in PD-L1-TC ≥1% patients in modified resected population
Time frame: From date of randomization to 5.5 years after date of resection
Major Pathological Response (mPR) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: Up to approximately 15 weeks after randomization
Overall Survival (OS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Time frame: From date of randomization to 5.5 years after randomization.
To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
Time frame: From date of screening to 6 months after last dose of IP
To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
Time frame: From date of screening to 6 months after last dose of IP
To assess the PK of durvalumab in blood
Time frame: From date of randomization to 2 months after resection
Presence of ADA for durvalumab
Time frame: From date of randomization to 3 months after last dose of IP

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 11 Jun 2025.
Derived from this study: PubMed 42802029Mitsudomi T, Heymach JV, Horio Y, Tanaka F, Tanaka H, Kuyama S, Okada M, Toyooka S, Watanabe Y, Reck M, Harpole D, Taube JM, Olivo Y, Xiong H, Fouad TM, Chen A, Akamatsu H. Perioperative Durvalumab for Resectable NSCLC: Updated Outcomes for Japanese Patients in AEGEAN. Cancer Sci. 2026 Sep 27:10.1111/cas.70541. doi: 10.1111/cas.70541. Online ahead of print.
Derived from this study: PubMed 40545237Mitsudomi T, Heymach JV, Reck M, Taube JM, Gao S, Horio Y, You J, Li G, Van Luong D, Saeteng S, Tanaka F, Watzka SB, Urban L, Szalai Z, Akamatsu H, Kang JH, Orlandi FJ, Mukhametshina GZ, Pircher A, Teixeira CHA, Aperghis M, Doherty GJ, Doake R, Fouad TM, Harpole D. Surgical Outcomes With Neoadjuvant Durvalumab Plus Chemotherapy Followed by Adjuvant Durvalumab in Resectable NSCLC. J Thorac Oncol. 2025 Nov;20(11):1639-1654. doi: 10.1016/j.jtho.2025.06.015. Epub 2025 Jun 20.
Derived from this study: PubMed 37870974Heymach JV, Harpole D, Mitsudomi T, Taube JM, Galffy G, Hochmair M, Winder T, Zukov R, Garbaos G, Gao S, Kuroda H, Ostoros G, Tran TV, You J, Lee KY, Antonuzzo L, Papai-Szekely Z, Akamatsu H, Biswas B, Spira A, Crawford J, Le HT, Aperghis M, Doherty GJ, Mann H, Fouad TM, Reck M; AEGEAN Investigators. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 2;389(18):1672-1684. doi: 10.1056/NEJMoa2304875. Epub 2023 Oct 23.
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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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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.

John Heymach, MD principal investigator

UT MD Anderson Cancer Center

231 sites in 28 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Durvalumab, Carboplatin and Cisplatin in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 231 sites in 28 countries.

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

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. 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 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 231 sites in China, United States, India, Japan, Brazil and 23 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?

Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population (time frame: Up to approximately 15 weeks after randomization). 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 NCT03800134, which also lists 3 linked publications.

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 11 Jun 2025.