Back to resultsStudy of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)
Primary Purpose
Small Cell Lung Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Tremelimumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Small Cell Lung Cancer focused on measuring Small Cell Lung Cancer, SCLC, LS-SCLC, Limited Stage, Carcinoma, Lung Cancer
Eligibility Criteria
Inclusion criteria:
- Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
- Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
- PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.
4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.
Exclusion criteria:
- Extensive-stage SCLC
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
- Active infection including tuberculosis, HIV, hepatitis B and C
- Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Durvalumab + Placebo
Durvalumab + Tremelimumab
Placebo + Placebo
Arm Description
Durvalumab monotherapy: Durvalumab (1500 mg intravenous [IV]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution.
Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab.
Placebo: Placebo saline solution (IV) q4w in combination with a second placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by a single placebo saline solution q4w. The first placebo saline solution monotherapy dose q4w will be 4 weeks after the final dose of the 2 placebo saline solutions in combination.
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of PFS
Overall Survival (OS)
To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of OS
Secondary Outcome Measures
Overall Survival (OS)
To assess the efficacy of Durvalumab & Tremelimumab combination therapy vs Placebo in terms of OS
Objective Response Rate (ORR)
Progression-free survival PFS
To assess the efficacy of durvalumab and tremelimumab combination therapy compared to placebo in terms of PFS
Progression-free survival at 18 months (PFS18)
Progression-free survival at 24 months (PFS24)
Time to death or distant metastasis (TTDM)
Proportion of patients alive at 24 months (OS24)
Proportion of patients alive at and 36 months (OS36)
Time from randomization to second progression (PFS2)
To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-C30 v3
To assess the PK of durvalumab and tremelimumab in blood (peak trough concentration)
Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative)
PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS & ORR).
To investigate the relationship between PDL1 expression & spatial distribution with Durva (mono) therapy & Durva+Treme (combination) therapy
To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-LC13
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03703297
Brief Title
Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy
Acronym
ADRIATIC
Official Title
A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients With Limited Stage Small Cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy (ADRIATIC)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
September 5, 2024 (Anticipated)
Study Completion Date
September 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase III, Randomized, Double-blind, Placebo-controlled, Multi-center, International Study of Durvalumab or Durvalumab and Tremelimumab as Consolidation Treatment for Patients with LS-SCLC Who Have Not Progressed Following Concurrent Chemoradiation Therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Cell Lung Cancer
Keywords
Small Cell Lung Cancer, SCLC, LS-SCLC, Limited Stage, Carcinoma, Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
730 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Durvalumab + Placebo
Arm Type
Experimental
Arm Description
Durvalumab monotherapy: Durvalumab (1500 mg intravenous [IV]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution.
Arm Title
Durvalumab + Tremelimumab
Arm Type
Experimental
Arm Description
Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab.
Arm Title
Placebo + Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo: Placebo saline solution (IV) q4w in combination with a second placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by a single placebo saline solution q4w. The first placebo saline solution monotherapy dose q4w will be 4 weeks after the final dose of the 2 placebo saline solutions in combination.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
MEDI4736
Intervention Description
Durvalumab IV (intravenous infusion)
Intervention Type
Drug
Intervention Name(s)
Tremelimumab
Intervention Description
Tremelimumab IV (intravenous infusion)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo IV (intravenous infusion)
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of PFS
Time Frame
Approximately 6 years
Title
Overall Survival (OS)
Description
To assess the efficacy of Durvalumab monotherapy vs Placebo in terms of OS
Time Frame
Approximately 6 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
To assess the efficacy of Durvalumab & Tremelimumab combination therapy vs Placebo in terms of OS
Time Frame
Approximately 6 years
Title
Objective Response Rate (ORR)
Time Frame
Approximately 6 years
Title
Progression-free survival PFS
Description
To assess the efficacy of durvalumab and tremelimumab combination therapy compared to placebo in terms of PFS
Time Frame
Approximately 6 years
Title
Progression-free survival at 18 months (PFS18)
Time Frame
Approximately 6 years
Title
Progression-free survival at 24 months (PFS24)
Time Frame
Approximately 6 years
Title
Time to death or distant metastasis (TTDM)
Time Frame
Approximately 6 years
Title
Proportion of patients alive at 24 months (OS24)
Time Frame
Approximately 6 years
Title
Proportion of patients alive at and 36 months (OS36)
Time Frame
Approximately 6 years
Title
Time from randomization to second progression (PFS2)
Time Frame
Approximately 6 years
Title
To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-C30 v3
Time Frame
Approximately 6 years
Title
To assess the PK of durvalumab and tremelimumab in blood (peak trough concentration)
Time Frame
Approximately 6 years
Title
Presence of anti-drug antibodies (ADA) for durvalumab and tremelimumab (confirmatory results: positive or negative)
Time Frame
Approximately 6 years
Title
PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS & ORR).
Description
To investigate the relationship between PDL1 expression & spatial distribution with Durva (mono) therapy & Durva+Treme (combination) therapy
Time Frame
Approximately 6 years
Title
To assess symptoms and health-related QoL in patients treated withdurvalumab or durvalumab and tremelimumab combination therapy compared to placebo using the EORTC QLQ-LC13
Time Frame
Approximately 6 years
Other Pre-specified Outcome Measures:
Title
Adverse Events
Time Frame
Approximately 6 years
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:
Histologically or cytologically documented limited-stage small cell lung cancer (stage I-III).
Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules.
PCI may be delivered at the discretion of investigator and local standard of care, and must be conducted after the end of cCRT and completed between 1 to 42 days to first dose of IP.
4 .Have not progressed following definitive concurrent chemoradiation 5 .Life expectancy ≥ 12 weeks at Day 1. 6. ECOG 0 or 1 at enrolment.
Exclusion criteria:
Extensive-stage SCLC
Active or prior documented autoimmune or inflammatory disorders
Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Active infection including tuberculosis, HIV, hepatitis B and C
Patients who received sequential chemotherapy and radiotherapy (no overlap of RT with chemotherapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haiyi Jiang, M.D.
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Research Site
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
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Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
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Research Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
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Research Site
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
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Research Site
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
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Research Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
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Research Site
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
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Research Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
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Research Site
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
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Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
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Research Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
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Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
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Research Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
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Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
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Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
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United States
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Research Site
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Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
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United States
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Research Site
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Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
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United States
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Research Site
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
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Research Site
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
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Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
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Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
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City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
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United States
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City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
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United States
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City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
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United States
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City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
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Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
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Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Research Site
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Research Site
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1012AAR
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5004BAL
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Research Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
Research Site
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
CA
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
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City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100036
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Research Site
City
Bengbu
ZIP/Postal Code
233060
Country
China
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130000
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610042
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350011
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230601
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200030
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110042
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430010
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430030
Country
China
Facility Name
Research Site
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Facility Name
Research Site
City
Brno
ZIP/Postal Code
639 00
Country
Czechia
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
775 21
Country
Czechia
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
703 00
Country
Czechia
Facility Name
Research Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Research Site
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
51109
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Research Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Research Site
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Research Site
City
Bengaluru
ZIP/Postal Code
560076
Country
India
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Research Site
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
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City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
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Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Research Site
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00100
Country
Italy
Facility Name
Research Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Research Site
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Research Site
City
Iwakuni-shi
ZIP/Postal Code
740-8510
Country
Japan
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Research Site
City
Koto-ku
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Research Site
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Research Site
City
Osakasayama
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Research Site
City
Sakai-shi
ZIP/Postal Code
591-8555
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-0873
Country
Japan
Facility Name
Research Site
City
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Research Site
City
Tokushima-shi
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
Research Site
City
Ube-shi
ZIP/Postal Code
755-0241
Country
Japan
Facility Name
Research Site
City
Changwon-si
ZIP/Postal Code
51353
Country
Korea, Republic of
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Research Site
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Research Site
City
Jinju-si
ZIP/Postal Code
52727
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Research Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Research Site
City
Den Bosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Research Site
City
Harderwijk
ZIP/Postal Code
3844 DG
Country
Netherlands
Facility Name
Research Site
City
Hengelo
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Olsztyn
ZIP/Postal Code
10-357
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Research Site
City
Tomaszów Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Research Site
City
Kirov
ZIP/Postal Code
610021
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Research Site
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Research Site
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Research Site
City
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Research Site
City
Oviedo
ZIP/Postal Code
33011
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
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Research Site
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Research Site
City
Keelung City
ZIP/Postal Code
20445
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
235
Country
Taiwan
Facility Name
Research Site
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Yunlin
ZIP/Postal Code
640
Country
Taiwan
Facility Name
Research Site
City
Adana
ZIP/Postal Code
01060
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06280
Country
Turkey
Facility Name
Research Site
City
Antalya
ZIP/Postal Code
07059
Country
Turkey
Facility Name
Research Site
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34030
Country
Turkey
Facility Name
Research Site
City
Izmir
ZIP/Postal Code
35620
Country
Turkey
Facility Name
Research Site
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Facility Name
Research Site
City
Samsun
Country
Turkey
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
70000
Country
Vietnam
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 refer 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
31948903
Citation
Senan S, Okamoto I, Lee GW, Chen Y, Niho S, Mak G, Yao W, Shire N, Jiang H, Cho BC. Design and Rationale for a Phase III, Randomized, Placebo-controlled Trial of Durvalumab With or Without Tremelimumab After Concurrent Chemoradiotherapy for Patients With Limited-stage Small-cell Lung Cancer: The ADRIATIC Study. Clin Lung Cancer. 2020 Mar;21(2):e84-e88. doi: 10.1016/j.cllc.2019.12.006. Epub 2019 Dec 28.
Results Reference
derived
Learn more about this trial
Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy
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