A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
NCT ID: NCT02087423
Last Updated: 2025-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
446 participants
INTERVENTIONAL
2014-02-25
2025-03-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MEDI4736
see below
MEDI4736
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.
Interventions
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MEDI4736
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
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Inclusion Criteria
* 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))
Exclusion Criteria
* 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)
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Phillip Dennis, MD, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Goodyear, Arizona, United States
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Santa Rosa, California, United States
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New Haven, Connecticut, United States
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Port Saint Lucie, Florida, United States
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Tampa, Florida, United States
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Lawrenceville, Georgia, United States
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Waterloo, Iowa, United States
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Topeka, Kansas, United States
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Bethesda, Maryland, United States
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Burlington, Massachusetts, United States
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Worcester, Massachusetts, United States
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Saint Louis Park, Minnesota, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Huntersville, North Carolina, United States
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Bismarck, North Dakota, United States
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Fargo, North Dakota, United States
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Blue Ash, Ohio, United States
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Canton, Ohio, United States
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Middletown, Ohio, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Fort Worth, Texas, United States
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Spokane, Washington, United States
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Wenatchee, Washington, United States
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Vienna, , Austria
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Brussels, , Belgium
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Ghent, , Belgium
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Gilly, , Belgium
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Kortrijk, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Regina, Saskatchewan, Canada
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Brno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Bordeaux, , France
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Brest, , France
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Créteil, , France
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Dijon, , France
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Le Mans, , France
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Marseille, , France
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Pessac, , France
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Rennes, , France
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Saint-Herblain, , France
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Toulouse, , France
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Berlin, , Germany
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Berlin, , Germany
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Borstel, , Germany
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Cologne, , Germany
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Dortmund, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Großhansdorf, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Budapest, , Hungary
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Budapest, , Hungary
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Győr, , Hungary
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Szolnok, , Hungary
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Tatabánya, , Hungary
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Törökbálint, , Hungary
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Candiolo, , Italy
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Catania, , Italy
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Milan, , Italy
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Monza, , Italy
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Orbassano, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Akashi-shi, , Japan
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Bunkyō City, , Japan
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Chūōku, , Japan
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Habikino-shi, , Japan
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Hidaka-shi, , Japan
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Hirakata-shi, , Japan
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Kashiwa, , Japan
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Kitaadachi-gun, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kurume-shi, , Japan
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Nagoya, , Japan
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Natori-shi, , Japan
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Osaka, , Japan
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Osaka, , Japan
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Sakaishi, , Japan
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Sayama, , Japan
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Sendai, , Japan
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Shinjuku-ku, , Japan
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Sunto-gun, , Japan
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Ube-shi, , Japan
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Yokohama, , Japan
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Yokohama, , Japan
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Cebu City, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Gdansk, , Poland
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Warsaw, , Poland
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Goyang-si, , South Korea
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Hwasun-gun, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Girona, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Taichung, , Taiwan
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Hat Yai, , Thailand
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Muang, , Thailand
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Edinburgh, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
Zhang 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.
Garassino 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.
Ouwens 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.
Garassino 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.
Related Links
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AstraZeneca Cancer Study Locator Service [email protected] 1-877-400-4656
d4191c00003 revised csp 4 Redacted
Other Identifiers
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2013-005427-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4191C00003
Identifier Type: -
Identifier Source: org_study_id
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