Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ATLANTIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02087423
Recruitment Status : Active, not recruiting
First Posted : March 14, 2014
Results First Posted : January 3, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: MEDI4736 Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 25, 2014
Actual Primary Completion Date : June 3, 2016
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: MEDI4736
see below
Drug: 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.




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Responses recorded during initial 12 month treatment period (up to primary analysis DCO) ]
    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 .


Secondary Outcome Measures :
  1. Time to Response (TTR) [ Time Frame: Responses recorded during initial 12 month treatment period (up to primary analysis DCO) ]
    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.

  2. Duration of Response (DoR) [ Time Frame: Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO) ]
    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.

  3. Overall Survival (OS) [ Time Frame: From date of first treatment until final DCO (up to approximately 3 years 8 months) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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))

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087423


  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Research Site
Goodyear, Arizona, United States
United States, California
Research Site
Santa Rosa, California, United States, 95403
United States, Connecticut
Research Site
New Haven, Connecticut, United States, 06520
United States, Florida
Research Site
Port Saint Lucie, Florida, United States, 34952
Research Site
Tampa, Florida, United States, 33612
United States, Georgia
Research Site
Lawrenceville, Georgia, United States, 30046
United States, Iowa
Research Site
Waterloo, Iowa, United States, 50701
United States, Kansas
Research Site
Topeka, Kansas, United States, 66604
United States, Maryland
Research Site
Bethesda, Maryland, United States, 20817
United States, Massachusetts
Research Site
Burlington, Massachusetts, United States, 01805
Research Site
Worcester, Massachusetts, United States, 01608
United States, Minnesota
Research Site
Saint Louis Park, Minnesota, United States, 55426
United States, New York
Research Site
Bronx, New York, United States, 10461
Research Site
New York, New York, United States, 10011
Research Site
New York, New York, United States, 10016
Research Site
New York, New York, United States, 10032
Research Site
New York, New York, United States, 10065
United States, North Carolina
Research Site
Huntersville, North Carolina, United States, 28078
United States, North Dakota
Research Site
Bismarck, North Dakota, United States, 58501
Research Site
Fargo, North Dakota, United States, 58102
United States, Ohio
Research Site
Canton, Ohio, United States, 44718
Research Site
Cincinnati, Ohio, United States, 45242
Research Site
Middleton, Ohio, United States, 45042
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States, 37404
Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
Fort Worth, Texas, United States, 76104
United States, Washington
Research Site
Spokane, Washington, United States, 99208-1129
Research Site
Wenatchee, Washington, United States, 98801
Austria
Research Site
Wien, Austria, 1145
Belgium
Research Site
Bruxelles, Belgium, 1000
Research Site
Gent, Belgium, 9000
Research Site
Gilly, Belgium, 6060
Research Site
Kortrijk, Belgium, 8500
Research Site
Leuven, Belgium, 3000
Research Site
Liège, Belgium, 4000
Canada, Ontario
Research Site
Hamilton, Ontario, Canada, L8V 5C2
Research Site
London, Ontario, Canada, N6A 4L6
Research Site
Ottawa, Ontario, Canada, K1H 8L6
Research Site
Toronto, Ontario, Canada, M4N 3M5
Research Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Saskatchewan
Research Site
Regina, Saskatchewan, Canada, S4T 7T1
Czechia
Research Site
Brno, Czechia, 656 53
Research Site
Praha 5, Czechia, 150 06
Research Site
Praha 8, Czechia, 180 81
Research Site
Praha, Czechia, 14059
France
Research Site
Bordeaux Cedex, France, 33076
Research Site
Brest Cedex, France, 29609
Research Site
Creteil, France, 94010
Research Site
Dijon, France, 21034
Research Site
Le Mans Cedex 02, France, 72015
Research Site
Marseille, France, 13915
Research Site
Pessac, France, 33604
Research Site
Rennes Cedex 09, France, 35033
Research Site
Saint Herblain Cedex, France, 44805
Research Site
Toulouse Cedex 9, France, 31059
Germany
Research Site
Berlin, Germany, 10967
Research Site
Berlin, Germany
Research Site
Borstel, Germany, 23845
Research Site
Dortmund, Germany, 44263
Research Site
Frankfurt am Main, Germany, 60590
Research Site
Freiburg, Germany, 79106
Research Site
Großhansdorf, Germany, 22927
Research Site
Hamburg, Germany, 20251
Research Site
Heidelberg, Germany, 69126
Research Site
Köln, Germany, 50924
Hungary
Research Site
Budapest, Hungary, 1125
Research Site
Budapest, Hungary, 1529
Research Site
Győr, Hungary, 9024
Research Site
Szolnok, Hungary, 5000
Research Site
Tatabanya, Hungary, 2800
Research Site
Torokbalint, Hungary, 2045
Italy
Research Site
Candiolo, Italy, 10060
Research Site
Catania, Italy, 95125
Research Site
Milano, Italy, 20133
Research Site
Monza, Italy, 20900
Research Site
Orbassano, Italy, 10043
Research Site
Perugia, Italy, 06132
Research Site
Pisa, Italy, 56124
Research Site
Roma, Italy, 00144
Research Site
Rozzano, Italy, 20089
Japan
Research Site
Akashi-shi, Japan, 673-8558
Research Site
Bunkyo-ku, Japan, 113-8603
Research Site
Chuo-ku, Japan, 104-0045
Research Site
Habikino-shi, Japan, 583-8588
Research Site
Hidaka-shi, Japan, 350-1298
Research Site
Hirakata-shi, Japan, 573-1191
Research Site
Kashiwa, Japan, 277-8577
Research Site
Kitaadachi-gun, Japan, 362-0806
Research Site
Kobe-shi, Japan, 650-0047
Research Site
Koto-ku, Japan, 135-8550
Research Site
Kurume-shi, Japan, 830-0011
Research Site
Nagoya-shi, Japan, 460-0001
Research Site
Natori-shi, Japan, 981-1293
Research Site
Osaka-shi, Japan, 534-0021
Research Site
Osaka-shi, Japan, 541-8567
Research Site
Osakasayama, Japan, 589-8511
Research Site
Sakai-shi, Japan, 591-8555
Research Site
Sendai-shi, Japan, 980-0873
Research Site
Shinjuku-ku, Japan, 160-0023
Research Site
Sunto-gun, Japan, 411-8777
Research Site
Ube-shi, Japan, 755-0241
Research Site
Yokohama-shi, Japan, 236-0051
Research Site
Yokohama-shi, Japan, 241-8515
Korea, Republic of
Research Site
Goyang-si, Korea, Republic of, 410-769
Research Site
Hwasun-gun, Korea, Republic of, 58128
Research Site
Seongnam-si, Korea, Republic of, 13620
Research Site
Seoul, Korea, Republic of, 03080
Research Site
Seoul, Korea, Republic of, 03722
Research Site
Seoul, Korea, Republic of, 05505
Research Site
Seoul, Korea, Republic of, 06351
Research Site
Seoul, Korea, Republic of, 152-703
Philippines
Research Site
Cebu City, Philippines, 6000
Research Site
Quezon City, Philippines, 0870
Research Site
Quezon City, Philippines
Poland
Research Site
Gdańsk, Poland, 80-952
Research Site
Warszawa, Poland, 02-781
Singapore
Research Site
Singapore, Singapore, 119228
Research Site
Singapore, Singapore, 169610
Research Site
Singapore, Singapore, 308440
Spain
Research Site
Barcelona, Spain, 08908
Research Site
Gerona, Spain, 17007
Research Site
Madrid, Spain, 28007
Research Site
Madrid, Spain, 28050
Research Site
Málaga, Spain, 29010
Research Site
Sevilla, Spain, 41009
Research Site
Sevilla, Spain, 41013
Research Site
Valencia, Spain, 46026
Taiwan
Research Site
Taichung, Taiwan, 404
Research Site
Taichung, Taiwan, 40705
Research Site
Tainan, Taiwan, 704
Research Site
Taipei, Taiwan, 10002
Research Site
Taipei, Taiwan, 112
Thailand
Research Site
Hat Yai, Thailand, 90110
Research Site
Muang, Thailand, 50200
United Kingdom
Research Site
Edinburgh, United Kingdom, EH4 2XU
Research Site
London, United Kingdom, EC1A 7BE
Research Site
Manchester, United Kingdom, M20 4BX
Research Site
Stoke-on-Trent, United Kingdom, ST4 6QG
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Study Director: Phillip Dennis, MD, PhD AstraZeneca

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02087423     History of Changes
Other Study ID Numbers: D4191C00003
First Posted: March 14, 2014    Key Record Dates
Results First Posted: January 3, 2018
Last Update Posted: March 1, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AstraZeneca:
Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, Durvalumab, PD-L1

Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Durvalumab
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs