A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
ATLANTIC
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
2 other identifiers
interventional
446
18 countries
139
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Feb 2014
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
139 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2014
CompletedFirst Submitted
Initial submission to the registry
March 4, 2014
CompletedFirst Posted
Study publicly available on registry
March 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2016
CompletedResults Posted
Study results publicly available
January 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2025
CompletedApril 27, 2025
April 1, 2025
2.3 years
March 4, 2014
June 3, 2017
April 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 .
Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Secondary Outcomes (3)
Time to Response (TTR)
Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Duration of Response (DoR)
Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)
Overall Survival (OS)
From date of first treatment until final DCO (up to approximately 3 years 8 months)
Study Arms (1)
MEDI4736
EXPERIMENTALsee below
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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))
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (139)
Research Site
Goodyear, Arizona, 85338, United States
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Santa Rosa, California, 95403, United States
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New Haven, Connecticut, 06511, United States
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Port Saint Lucie, Florida, 34952, United States
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Tampa, Florida, 33612, United States
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Lawrenceville, Georgia, 30046, United States
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Waterloo, Iowa, 50701, United States
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Topeka, Kansas, 66606, United States
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Bethesda, Maryland, 20817, United States
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Burlington, Massachusetts, 01803, United States
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Worcester, Massachusetts, 01608, United States
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Saint Louis Park, Minnesota, 55426, United States
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New York, New York, 10011, United States
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New York, New York, 10016, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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The Bronx, New York, 10461, United States
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Huntersville, North Carolina, 28078, United States
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Bismarck, North Dakota, 58501, United States
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Fargo, North Dakota, 58102, United States
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Blue Ash, Ohio, 45242, United States
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Canton, Ohio, 44718, United States
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Middletown, Ohio, 45042, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Fort Worth, Texas, 76104, United States
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Spokane, Washington, 99208, United States
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Wenatchee, Washington, 98801, United States
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Vienna, 1145, Austria
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Brussels, 1000, Belgium
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Ghent, 9000, Belgium
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Gilly, 6060, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Hamilton, Ontario, L8V 5C2, Canada
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London, Ontario, N6A 4L6, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Regina, Saskatchewan, S4T 7T1, Canada
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Brno, 656 53, Czechia
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Prague, 14059, Czechia
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Prague, 150 06, Czechia
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Prague, 180 81, Czechia
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Bordeaux, 33076, France
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Brest, 29609, France
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Créteil, 94010, France
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Dijon, 21034, France
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Le Mans, 72015, France
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Marseille, 13015, France
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Pessac, 33600, France
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Rennes, 35033, France
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Saint-Herblain, 44805, France
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Toulouse, 31059, France
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Berlin, 10967, Germany
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Berlin, Germany
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Borstel, 23845, Germany
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Cologne, 50924, Germany
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Dortmund, 44263, Germany
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Frankfurt am Main, 60590, Germany
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Freiburg im Breisgau, 79106, Germany
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Großhansdorf, 22927, Germany
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Hamburg, 20251, Germany
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Heidelberg, 69126, Germany
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Budapest, 1083, Hungary
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Budapest, 1121, Hungary
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Győr, 9024, Hungary
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Szolnok, 5000, Hungary
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Tatabánya, 2800, Hungary
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Törökbálint, 2045, Hungary
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Candiolo, 10060, Italy
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Catania, 95125, Italy
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Milan, 20133, Italy
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Monza, 20900, Italy
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Orbassano, 10043, Italy
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Perugia, 06132, Italy
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Pisa, 56124, Italy
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Roma, 00144, Italy
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Rozzano, 20089, Italy
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Akashi-shi, 673-8558, Japan
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Bunkyō City, 113-8603, Japan
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Chūōku, 104-0045, Japan
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Habikino-shi, 583-8588, Japan
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Hidaka-shi, 350-1298, Japan
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Hirakata-shi, 573-1191, Japan
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Kashiwa, 277-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kobe, 650-0047, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Nagoya, 460-0001, Japan
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Natori-shi, 981-1293, Japan
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Osaka, 534-0021, Japan
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Osaka, 541-8567, Japan
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Sakaishi, 591-8555, Japan
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Sayama, 589-8511, Japan
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Sendai, 980-0873, Japan
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Shinjuku-ku, 160-0023, Japan
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Sunto-gun, 411-8777, Japan
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Ube-shi, 755-0241, Japan
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Yokohama, 236-0051, Japan
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Yokohama, 241-8515, Japan
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Cebu City, 6000, Philippines
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Quezon City, 0870, Philippines
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Quezon City, 1100, Philippines
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Quezon City, 1101, Philippines
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Gdansk, 80-952, Poland
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Warsaw, 02-781, Poland
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Singapore, 119228, Singapore
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Singapore, 169610, Singapore
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Singapore, 308440, Singapore
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Goyang-si, 10408, South Korea
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Hwasun-gun, 58128, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 152-703, South Korea
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Barcelona, 08908, Spain
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Girona, 17007, Spain
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Madrid, 28007, Spain
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Madrid, 28050, Spain
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Málaga, 29010, Spain
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Seville, 41009, Spain
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Seville, 41013, Spain
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Valencia, 46026, Spain
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Taichung, 40447, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Hat Yai, 90110, Thailand
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Muang, 50200, Thailand
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Edinburgh, EH4 2XU, United Kingdom
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London, EC1A 7BE, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Stoke-on-Trent, ST4 6QG, United Kingdom
Related Publications (5)
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.
PMID: 33319498DERIVEDZhang 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.
PMID: 32816849DERIVEDGarassino 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.
PMID: 32702570DERIVEDOuwens 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.
PMID: 31102143DERIVEDGarassino 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.
PMID: 29545095DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Phillip Dennis, MD, PhD
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
Phillip Dennis, MD, PhD
AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2014
First Posted
March 14, 2014
Study Start
February 25, 2014
Primary Completion
June 3, 2016
Study Completion
March 26, 2025
Last Updated
April 27, 2025
Results First Posted
January 3, 2018
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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