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

January 17, 2024 updated by: AstraZeneca

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1145
        • Research Site
  • Belgium
      • Brussel, 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
        • Research Site
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Research Site
      • London, Ontario, Canada, N6A 4L6
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Research Site
  • Czechia
      • Brno, Czechia, 656 53
        • Research Site
      • Praha, Czechia, 14059
        • Research Site
      • Praha 5, Czechia, 150 06
        • Research Site
      • Praha 8, Czechia, 180 81
        • Research Site
  • France
      • 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, 13015
        • Research Site
      • Pessac, France, 33600
        • Research Site
      • Rennes Cedex 09, France, 35033
        • Research Site
      • Saint Herblain Cedex, France, 44805
        • Research Site
      • Toulouse Cedex 9, France, 31059
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Berlin, Germany, 10967
        • 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
        • Research Site
  • Hungary
      • Budapest, Hungary, 1083
        • Research Site
      • Budapest, Hungary, 1121
        • Research Site
      • Győr, Hungary, 9024
        • Research Site
      • Szolnok, Hungary, 5000
        • Research Site
      • Tatabánya, Hungary, 2800
        • Research Site
      • Törökbálint, Hungary, 2045
        • Research Site
  • Italy
      • 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
        • Research Site
  • Japan
      • 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, 541-8567
        • Research Site
      • Osaka-shi, Japan, 534-0021
        • 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, 241-8515
        • Research Site
      • Yokohama-shi, Japan, 236-0051
        • Research Site
  • Korea, Republic of
      • 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, 03722
        • Research Site
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 03080
        • Research Site
      • Seoul, Korea, Republic of, 06351
        • Research Site
      • Seoul, Korea, Republic of, 152-703
        • Research Site
  • Philippines
      • Cebu City, Philippines, 6000
        • Research Site
      • Quezon City, Philippines, 1101
        • Research Site
      • Quezon City, Philippines, 1100
        • Research Site
      • Quezon City, Philippines, 0870
        • Research Site
  • Poland
      • Gdańsk, Poland, 80-952
        • Research Site
      • Warszawa, Poland, 02-781
        • Research Site
  • Singapore
      • Singapore, Singapore, 169610
        • Research Site
      • Singapore, Singapore, 119228
        • Research Site
      • Singapore, Singapore, 308440
        • Research Site
  • Spain
      • Barcelona, Spain, 08908
        • Research Site
      • Gerona, Spain, 17007
        • Research Site
      • Madrid, Spain, 28050
        • Research Site
      • Madrid, Spain, 28007
        • Research Site
      • Málaga, Spain, 29010
        • Research Site
      • Sevilla, Spain, 41009
        • Research Site
      • Sevilla, Spain, 41013
        • Research Site
      • Valencia, Spain, 46026
        • Research Site
  • Taiwan
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan, 40447
        • Research Site
      • Tainan, Taiwan, 704
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 112
        • Research Site
  • Thailand
      • Hat Yai, Thailand, 90110
        • Research Site
      • Muang, Thailand, 50200
        • Research Site
  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Research Site
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Research Site
  • United States
    • Arizona
      • Goodyear, Arizona, United States
        • Research Site
    • California
      • Santa Rosa, California, United States, 95403
        • Research Site
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Research Site
    • Florida
      • Port Saint Lucie, Florida, United States, 34952
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Research Site
    • Iowa
      • Waterloo, Iowa, United States, 50701
        • Research Site
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Research Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01803
        • Research Site
      • Worcester, Massachusetts, United States, 01608
        • Research Site
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Research Site
    • New York
      • Bronx, New York, United States, 10461
        • 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
        • Research Site
      • New York, New York, United States, 10011
        • Research Site
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Research Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Research Site
      • Fargo, North Dakota, United States, 58102
        • Research Site
    • Ohio
      • Blue Ash, Ohio, United States, 45242
        • Research Site
      • Canton, Ohio, United States, 44718
        • Research Site
      • Middletown, Ohio, United States, 45042
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Research Site
      • Nashville, Tennessee, United States, 37203
        • Research Site
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99208
        • Research Site
      • Wenatchee, Washington, United States, 98801
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
Responses recorded during initial 12 month treatment period (up to primary analysis DCO)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
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.
Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)
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.
From date of first treatment until final DCO (up to approximately 3 years 8 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Phillip Dennis, MD, PhD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2014

Primary Completion (Actual)

June 3, 2016

Study Completion (Estimated)

June 28, 2024

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (Estimated)

March 14, 2014

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4191C00003
  • 2013-005427-16 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing 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

IPD Sharing 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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