Back to resultsA Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer (ATLANTIC)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MEDI4736
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, Durvalumab, PD-L1
Eligibility 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)
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MEDI4736
Arm Description
see below
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02087423
Brief Title
A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
Acronym
ATLANTIC
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2014 (Actual)
Primary Completion Date
June 3, 2016 (Actual)
Study Completion Date
June 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Locally advanced, metastatic, Non-Small Cell Lung Cancer, MEDI4736, Durvalumab, PD-L1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
446 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI4736
Arm Type
Experimental
Arm Description
see below
Intervention Type
Drug
Intervention Name(s)
MEDI4736
Intervention Description
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 Measure Information:
Title
Objective Response Rate (ORR)
Description
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 .
Time Frame
Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Secondary Outcome Measure Information:
Title
Time to Response (TTR)
Description
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.
Time Frame
Responses recorded during initial 12 month treatment period (up to primary analysis DCO)
Title
Duration of Response (DoR)
Description
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 Frame
Time from response to progression, death, or last assessment (up to approximately 2 years 3 months for the primary analysis DCO)
Title
Overall Survival (OS)
Description
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.
Time Frame
From date of first treatment until final DCO (up to approximately 3 years 8 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phillip Dennis, MD, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Goodyear
State/Province
Arizona
Country
United States
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Research Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
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United States
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Research Site
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New Haven
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Connecticut
ZIP/Postal Code
06511
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United States
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Port Saint Lucie
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Florida
ZIP/Postal Code
34952
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United States
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Tampa
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Florida
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33612
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United States
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Lawrenceville
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Georgia
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30046
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United States
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Waterloo
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Iowa
ZIP/Postal Code
50701
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United States
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Topeka
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Kansas
ZIP/Postal Code
66606
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United States
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Bethesda
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Maryland
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20817
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United States
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Burlington
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Massachusetts
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01803
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United States
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Worcester
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Massachusetts
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01608
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United States
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Saint Louis Park
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Minnesota
ZIP/Postal Code
55426
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United States
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Bronx
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New York
ZIP/Postal Code
10461
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United States
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City
New York
State/Province
New York
ZIP/Postal Code
10011
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United States
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City
New York
State/Province
New York
ZIP/Postal Code
10016
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United States
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City
New York
State/Province
New York
ZIP/Postal Code
10032
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United States
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New York
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New York
ZIP/Postal Code
10065
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United States
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Huntersville
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North Carolina
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28078
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United States
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Bismarck
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North Dakota
ZIP/Postal Code
58501
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United States
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Fargo
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North Dakota
ZIP/Postal Code
58102
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United States
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Blue Ash
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Ohio
ZIP/Postal Code
45242
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United States
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City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
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United States
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Middletown
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Ohio
ZIP/Postal Code
45042
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United States
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Chattanooga
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Tennessee
ZIP/Postal Code
37404
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United States
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Nashville
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Tennessee
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37203
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United States
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Fort Worth
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Texas
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76104
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United States
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Spokane
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Washington
ZIP/Postal Code
99208
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United States
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City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
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United States
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City
Wien
ZIP/Postal Code
1145
Country
Austria
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Brussel
ZIP/Postal Code
1000
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Belgium
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Gent
ZIP/Postal Code
9000
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Belgium
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Gilly
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6060
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Belgium
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Kortrijk
ZIP/Postal Code
8500
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Belgium
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Leuven
ZIP/Postal Code
3000
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Belgium
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Liège
ZIP/Postal Code
4000
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Belgium
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Hamilton
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Ontario
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L8V 5C2
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Canada
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London
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Ontario
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N6A 4L6
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Canada
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Ottawa
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Ontario
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K1H 8L6
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Canada
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Toronto
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Ontario
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M4N 3M5
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Canada
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City
Toronto
State/Province
Ontario
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M5G 2M9
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Canada
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Regina
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Saskatchewan
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S4T 7T1
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Canada
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Brno
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656 53
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Czechia
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Praha 5
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150 06
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Czechia
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Praha 8
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180 81
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Czechia
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Praha
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14059
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Czechia
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Bordeaux Cedex
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33076
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France
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Brest Cedex
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29609
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France
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Creteil
ZIP/Postal Code
94010
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France
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Dijon
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21034
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France
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Le Mans Cedex 02
ZIP/Postal Code
72015
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France
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Marseille
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13015
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France
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Pessac
ZIP/Postal Code
33600
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France
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Rennes Cedex 09
ZIP/Postal Code
35033
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France
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Saint Herblain Cedex
ZIP/Postal Code
44805
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France
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City
Toulouse Cedex 9
ZIP/Postal Code
31059
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France
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City
Berlin
ZIP/Postal Code
10967
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Germany
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Berlin
Country
Germany
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City
Borstel
ZIP/Postal Code
23845
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Germany
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Dortmund
ZIP/Postal Code
44263
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Germany
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City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
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City
Freiburg
ZIP/Postal Code
79106
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Germany
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City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
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City
Hamburg
ZIP/Postal Code
20251
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Germany
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Heidelberg
ZIP/Postal Code
69126
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Germany
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City
Köln
ZIP/Postal Code
50924
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Germany
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Budapest
ZIP/Postal Code
1083
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Hungary
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City
Budapest
ZIP/Postal Code
1121
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Hungary
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City
Győr
ZIP/Postal Code
9024
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Hungary
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City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
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City
Tatabánya
ZIP/Postal Code
2800
Country
Hungary
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City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
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City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
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City
Catania
ZIP/Postal Code
95125
Country
Italy
Facility Name
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City
Milano
ZIP/Postal Code
20133
Country
Italy
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City
Monza
ZIP/Postal Code
20900
Country
Italy
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City
Orbassano
ZIP/Postal Code
10043
Country
Italy
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City
Perugia
ZIP/Postal Code
06132
Country
Italy
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City
Pisa
ZIP/Postal Code
56124
Country
Italy
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Roma
ZIP/Postal Code
00144
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Italy
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Rozzano
ZIP/Postal Code
20089
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Italy
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Akashi-shi
ZIP/Postal Code
673-8558
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Japan
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City
Bunkyo-ku
ZIP/Postal Code
113-8603
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Japan
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City
Chuo-ku
ZIP/Postal Code
104-0045
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Japan
Facility Name
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City
Habikino-shi
ZIP/Postal Code
583-8588
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Japan
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City
Hidaka-shi
ZIP/Postal Code
350-1298
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Japan
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Hirakata-shi
ZIP/Postal Code
573-1191
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Japan
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City
Kashiwa
ZIP/Postal Code
277-8577
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Japan
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Kitaadachi-gun
ZIP/Postal Code
362-0806
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Japan
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Kobe-shi
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650-0047
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Japan
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Koto-ku
ZIP/Postal Code
135-8550
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Japan
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Kurume-shi
ZIP/Postal Code
830-0011
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Japan
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City
Nagoya-shi
ZIP/Postal Code
460-0001
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Japan
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City
Natori-shi
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981-1293
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Japan
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City
Osaka-shi
ZIP/Postal Code
534-0021
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Japan
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City
Osaka-shi
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541-8567
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Japan
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City
Osakasayama
ZIP/Postal Code
589-8511
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Japan
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City
Sakai-shi
ZIP/Postal Code
591-8555
Country
Japan
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City
Sendai-shi
ZIP/Postal Code
980-0873
Country
Japan
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City
Shinjuku-ku
ZIP/Postal Code
160-0023
Country
Japan
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City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
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Research Site
City
Ube-shi
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
236-0051
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Research Site
City
Hwasun-gun
ZIP/Postal Code
58128
Country
Korea, Republic of
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Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
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Research Site
City
Seoul
ZIP/Postal Code
03080
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Korea, Republic of
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Research Site
City
Seoul
ZIP/Postal Code
03722
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Korea, Republic of
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Research Site
City
Seoul
ZIP/Postal Code
05505
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Korea, Republic of
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Research Site
City
Seoul
ZIP/Postal Code
06351
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Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
152-703
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Korea, Republic of
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Research Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
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Research Site
City
Quezon City
ZIP/Postal Code
0870
Country
Philippines
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Research Site
City
Quezon City
ZIP/Postal Code
1100
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Philippines
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City
Quezon City
ZIP/Postal Code
1101
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Philippines
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City
Gdańsk
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80-952
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Poland
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City
Warszawa
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02-781
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Poland
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Singapore
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119228
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Singapore
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City
Singapore
ZIP/Postal Code
169610
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Singapore
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Singapore
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308440
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Singapore
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Barcelona
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08908
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Spain
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City
Gerona
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17007
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Spain
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Madrid
ZIP/Postal Code
28007
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Spain
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City
Madrid
ZIP/Postal Code
28050
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Spain
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Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Research Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Stoke-on-Trent
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
33319498
Citation
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.
Results Reference
derived
PubMed Identifier
32816849
Citation
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.
Results Reference
derived
PubMed Identifier
32702570
Citation
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.
Results Reference
derived
PubMed Identifier
31102143
Citation
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.
Results Reference
derived
PubMed Identifier
29545095
Citation
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.
Results Reference
derived
Links:
URL
http://www.emergingmed.com
Description
AstraZeneca Cancer Study Locator Service astrazeneca@emergingmed.com 1-877-400-4656
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2583&filename=d4191c00003-revised-csp-4_Redacted.pdf
Description
d4191c00003 revised csp 4 Redacted
Learn more about this trial
A Global Study to Assess the Effects of MEDI4736 (Durvalumab) in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
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