Non-Small Cell Lung CancerPhase 2ATLANTICNCT02087423
A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
A Phase 2 study testing MEDI4736 in people with Non-Small Cell Lung Cancer, run by AstraZeneca at 139 sites in 18 countries.
Trial summary
A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- MEDI4736
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 139 sitesin 18 countries
- Study dates
- 25 Feb 2014to 26 Mar 2025
- Phase
- Phase 2
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
Who may be able to join
- Aged at least 18 years.
- Documented evidence of NSCLC (stage IIIB/IV disease)
- Disease progression or recurrence after both a platinum-based chemotherapy and at least 1 additional regimen for treatment of NSCLC
- World Health Organisation (WHO) Performance Status of 0 or 1
- Estimated life expectancy of more than 12 weeks
- Patient's tumour sample must be PD-L1 positive (≥25%of tumour cells with membrane staining (Cohort 1 and 2) or PD-L1 positive with ≥90% of tumour cells with membrane staining (Cohort 3))
Who cannot join
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- Brain metastases or spinal cord compression or unless asymptomatic, treated and stable (not requiring steroids).
- Active or prior autoimmune disease or history of immunodeficiency
- Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
- Evidence of uncontrolled illness such as symptomatic congestive heart failure, uncontrolled hypertension or unstable angina pectoris.
- Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy.
- Any prior Grade ≥3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
Trial locations and contacts
139 sites in 18 countries.
139 sites in 18 countries
United States28 sites
Research Site
Bethesda, Maryland, 20817
Research Site
Bismarck, North Dakota, 58501
Research Site
Blue Ash, Ohio, 45242
Research Site
Burlington, Massachusetts, 01803
Research Site
Canton, Ohio, 44718
Research Site
Chattanooga, Tennessee, 37404
Research Site
Fargo, North Dakota, 58102
Research Site
Fort Worth, Texas, 76104
Research Site
Goodyear, Arizona, 85338
Research Site
Huntersville, North Carolina, 28078
Research Site
Lawrenceville, Georgia, 30046
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Middletown, Ohio, 45042
Research Site
Nashville, Tennessee, 37203
Research Site
New Haven, Connecticut, 06511
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New York, New York, 10011
Research Site
New York, New York, 10016
Research Site
New York, New York, 10032
Research Site
New York, New York, 10065
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Port Saint Lucie, Florida, 34952
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Saint Louis Park, Minnesota, 55426
Research Site
Santa Rosa, California, 95403
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Spokane, Washington, 99208
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Tampa, Florida, 33612
Research Site
The Bronx, New York, 10461
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Topeka, Kansas, 66606
Research Site
Waterloo, Iowa, 50701
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Wenatchee, Washington, 98801
Research Site
Worcester, Massachusetts, 01608
Japan23 sites
Research Site
Akashi-shi, 673-8558
Research Site
Bunkyō City, 113-8603
Research Site
Chūōku, 104-0045
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Habikino-shi, 583-8588
Research Site
Hidaka-shi, 350-1298
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Hirakata-shi, 573-1191
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Kashiwa, 277-8577
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Kitaadachi-gun, 362-0806
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Kobe, 650-0047
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Kōtoku, 135-8550
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Kurume-shi, 830-0011
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Nagoya, 460-0001
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Natori-shi, 981-1293
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Osaka, 534-0021
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Osaka, 541-8567
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Sakaishi, 591-8555
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Sayama, 589-8511
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Sendai, 980-0873
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Shinjuku-ku, 160-0023
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Sunto-gun, 411-8777
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Ube-shi, 755-0241
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Yokohama, 236-0051
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Yokohama, 241-8515
France10 sites
Research Site
Bordeaux, 33076
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Brest, 29609
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Créteil, 94010
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Dijon, 21034
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Le Mans, 72015
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Marseille, 13015
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Pessac, 33600
Research Site
Rennes, 35033
Research Site
Saint-Herblain, 44805
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Toulouse, 31059
Germany10 sites
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Berlin, 10967
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Berlin, 13585
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Borstel, 23845
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Cologne, 50924
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Dortmund, 44263
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Frankfurt am Main, 60590
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Freiburg im Breisgau, 79106
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Großhansdorf, 22927
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Hamburg, 20251
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Heidelberg, 69126
Italy9 sites
Research Site
Candiolo, 10060
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Catania, 95125
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Milan, 20133
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Monza, 20900
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Orbassano, 10043
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Perugia, 06132
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Pisa, 56124
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Roma, 00144
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Rozzano, 20089
South Korea8 sites
Research Site
Goyang-si, 10408
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Hwasun-gun, 58128
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Seongnam-si, 13620
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Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Seoul, 06351
Research Site
Seoul, 152-703
Spain8 sites
Research Site
Barcelona, 08908
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Girona, 17007
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Madrid, 28007
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Madrid, 28050
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Málaga, 29010
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Seville, 41009
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Seville, 41013
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Valencia, 46026
Belgium6 sites
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Brussels, 1000
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Ghent, 9000
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Gilly, 6060
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Kortrijk, 8500
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Leuven, 3000
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Liège, 4000
Canada6 sites
Research Site
Hamilton, Ontario, L8V 5C2
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London, Ontario, N6A 4L6
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Ottawa, Ontario, K1H 8L6
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Regina, Saskatchewan, S4T 7T1
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Toronto, Ontario, M4N 3M5
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Toronto, Ontario, M5G 2M9
Hungary6 sites
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Budapest, 1083
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Budapest, 1121
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Győr, 9024
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Szolnok, 5000
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Tatabánya, 2800
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Törökbálint, 2045
Taiwan5 sites
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Taichung, 40447
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Taichung, 40705
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Tainan, 704
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Taipei, 10002
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Taipei, 112
Czechia4 sites
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Brno, 656 53
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Prague, 14059
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Prague, 150 06
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Prague, 180 81
Philippines4 sites
Research Site
Cebu City, 6000
Research Site
Quezon City, 0870
Research Site
Quezon City, 1100
Research Site
Quezon City, 1101
United Kingdom4 sites
Research Site
Edinburgh, EH4 2XU
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London, EC1A 7BE
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Manchester, M20 4BX
Research Site
Stoke-on-Trent, ST4 6QG
Singapore3 sites
Research Site
Singapore, 119228
Research Site
Singapore, 169610
Research Site
Singapore, 308440
About this study
Official title: A Phase II,Non-comparative,Open Label, Multi-centre, International Study of MEDI4736, in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB-IV) Who Have Received at Least 2 Prior Systemic Treatment Regimens Including 1 Platinum-based Chemotherapy Regimen
A study to assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer in terms of efficacy, safety and tolerability
Read the detailed description
This study is designed to investigate the efficacy, safety, tolerability of a new drug, MEDI4736 (Durvalumab), in patients with Locally Advanced or Metastatic Non Small Cell Lung Cancer. MEDI4736 will be investigated in patients who have received at least two prior treatment regimens including one platinum-based chemotherapy
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- MEDI4736
- Keywords
- Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, Durvalumab, PD-L1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI4736Drug
MEDI4736 (durvalumab) by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Patients who achieve CR, PR or SD through the end of the initial 12-month treatment period can restart treatment with MEDI4736 (durvalumab) when they eventually do progress. This retreatment period can continue for as long as the investigator considers to patient to be receiving clinical benefit.
| Study group | Role | What they receive |
|---|---|---|
| MEDI4736 | Experimental | see below Receives: Drug: MEDI4736 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Patients commenced treatment with durvalumab on Day 1 and continued on a Q2W schedule for a maximum of 12 months. Tumor assessments using computed tomography / magnetic resonance imaging were performed every 8 weeks. Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) measurements as given by the Independent Central Review (ICR) were used to derive the primary variable of ORR .
Measured: Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Secondary outcomes (3)
Time to Response (TTR)
TTR (per RECIST 1.1 as assessed by the ICR) is defined as the time from the date of first dose until the date of first documented response (which is subsequently confirmed). TTR was only analyzed for Cohort 2.
Measured: Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Duration of Response (DoR)
DoR (per RECIST 1.1 as assessed by the ICR) was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of disease progression (ie, date of PFS event or censoring - date of first response + 1). DoR was only analyzed for Cohort 2. Cohort 2: Median DoR was 12.3 months in the PD-L1 high (TC>=25%) group at DCO (Q3 was NR). Of the 7 evaluable patients, the median DoR was not reached in the PD-L1 low/neg group (TC <25%); therefore the DoR "number of participants analyzed" field has been entered as "0" and the DoR results field has been left blank.
Measured: Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)
Overall Survival (OS)
OS was defined as the time from the date of first dose until death due to any cause (ie, date of death or censoring - date of first dose + 1). Results are reported as median OS, calculated using the Kaplan-Meier methodology.
Measured: From date of first treatment until final DCO (up to approximately 3 years 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study start25 Feb 2014
- Primary completion3 Jun 2016
- Study completion26 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phillip Dennis, MD, PhD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087423
- Sponsor's protocol ID
- D4191C00003
- Other IDs
- 2013-005427-16
- Acronym
- ATLANTIC
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2014
- Last updated
- 6 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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
Publications
Gavrilov S, Zhudenkov K, Helmlinger G, Dunyak J, Peskov K, Aksenov S. Longitudinal Tumor Size and Neutrophil-to-Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Treated With Durvalumab. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):67-74. doi: 10.1002/psp4.12578. Epub 2020 Dec 21.
PubMed 33319498Zhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14.
PubMed 32816849Garassino MC, Cho BC, Kim JH, Mazieres J, Vansteenkiste J, Lena H, Jaime JC, Gray JE, Powderly J, Chouaid C, Bidoli P, Wheatley-Price P, Park K, Soo RA, Poole L, Wadsworth C, Dennis PA, Rizvi NA. Final overall survival and safety update for durvalumab in third- or later-line advanced NSCLC: The phase II ATLANTIC study. Lung Cancer. 2020 Sep;147:137-142. doi: 10.1016/j.lungcan.2020.06.032. Epub 2020 Jun 30.
PubMed 32702570Ouwens MJNM, Mukhopadhyay P, Zhang Y, Huang M, Latimer N, Briggs A. Estimating Lifetime Benefits Associated with Immuno-Oncology Therapies: Challenges and Approaches for Overall Survival Extrapolations. Pharmacoeconomics. 2019 Sep;37(9):1129-1138. doi: 10.1007/s40273-019-00806-4.
PubMed 31102143Garassino MC, Cho BC, Kim JH, Mazieres J, Vansteenkiste J, Lena H, Corral Jaime J, Gray JE, Powderly J, Chouaid C, Bidoli P, Wheatley-Price P, Park K, Soo RA, Huang Y, Wadsworth C, Dennis PA, Rizvi NA; ATLANTIC Investigators. Durvalumab as third-line or later treatment for advanced non-small-cell lung cancer (ATLANTIC): an open-label, single-arm, phase 2 study. Lancet Oncol. 2018 Apr;19(4):521-536. doi: 10.1016/S1470-2045(18)30144-X. Epub 2018 Mar 12.
PubMed 29545095