Back to resultsA Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC-9)
Primary Purpose
Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Durvalumab
Oleclumab
Monalizumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Non-Small Cell Lung Cancer, Locally Advanced NSCLC
Eligibility Criteria
INCLUSION CRITERIA:
- Participant must be ≥ 18 years at the time of screening.
- Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
- Provision of a tumour tissue sample obtained prior to CRT
- Documented tumour PD-L1 status by central lab
- Documented EGFR and ALK wild-type status (local or central).
- Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
- Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy,
- Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
- WHO performance status of 0 or 1 at randomization
- Adequate organ and marrow function
EXCLUSION CRITERIA:
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease > 5 years before the first dose of study intervention and of low potential risk for recurrence, basal cell carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna that has undergone potentially curative therapy, adequately treated carcinoma in situ or Ta tumours treated with curative intent and without evidence of disease.
- Mixed small cell and non-small cell lung cancer histology.
- Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
- Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
- Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
- Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, ILD, pleural effusion, or pulmonary fibrosis diagnosed in the past 6 months prior to randomization.
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Arm A: Durvalumab and Oleclumab
Arm B: Durvalumab and Monalizumab
Arm C: Durvalumab and Placebo
Arm Description
Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only
Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Outcomes
Primary Outcome Measures
Progression Free Surival (PFS)
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.
Secondary Outcome Measures
Overall Survival (OS)
Overall survival (OS)
Objective response rate (ORR)
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
Overall survival (OS) at 24 months
Overall survival (OS) at 24 months
Duration of response (DoR)
Duration of response (DoR) per RECIST 1.1 as assessed by BICR
Progression free survival (PFS) at 6, 12, 18, and 24 months
Progression free survival (PFS) at 6, 12, 18, and 24 months respectively, per RECIST 1.1 as assessed by BICR
Time from randomization to second progression (PFS2)
Time from randomization to second progression (PFS2)
Time from randomization to first date of distant metastasis or death (TTDM)
Time from randomization to first date of distant metastasis or death (TTDM)
Time from randomization to start date of first subsequent therapy (TFST)
Time from randomization to start date of first subsequent therapy (TFST)
Progression free survival (PFS) as assessed by Investigator
Progression free survival (PFS) as assessed by Investigator
IHC analysis of PD-L1 TC expression
IHC analysis of PD-L1 TC expression relative to efficacy outcomes
Concentration of Durvalumab
To assess the Pharmacokinetics of Durvalumab when in combination with Monalizumab or Oleclumab - serum peak and trough concentrations
Anti-drug antibodies (ADAs)
The immunogenicity of durvalumab, oleclumab, and monalizumab as assessed by presence of anti-drug antibodies (ADAs)
Time to deterioration in pulmonary symptoms (TTFCD)
Time to deterioration in pulmonary symptoms (TTFCD)
Concentration of Oleclumab
To assess the Pharmacokinetics of Oleclumab when in combination with Durvulumab - serum peak and trough concentrations
Concentration of Monalizumab
To assess the Pharmacokinetics of Monalizumab when in combination with Durvalumab - serum peak and trough concentrations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05221840
Brief Title
A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
Acronym
PACIFIC-9
Official Title
A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2022 (Actual)
Primary Completion Date
May 29, 2026 (Anticipated)
Study Completion Date
May 31, 2030 (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, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
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
Non-Small Cell Lung Cancer, Locally Advanced NSCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
999 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Durvalumab and Oleclumab
Arm Type
Experimental
Arm Description
Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Arm Title
Arm B: Durvalumab and Monalizumab
Arm Type
Experimental
Arm Description
Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only
Arm Title
Arm C: Durvalumab and Placebo
Arm Type
Active Comparator
Arm Description
Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
Durvalumab IV (intravenous infusion)
Intervention Type
Drug
Intervention Name(s)
Oleclumab
Intervention Description
Oleclumab IV (intravenous infusion)
Intervention Type
Drug
Intervention Name(s)
Monalizumab
Intervention Description
Monalizumab IV (intravenous infusion)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo IV (intravenous infusion)
Primary Outcome Measure Information:
Title
Progression Free Surival (PFS)
Description
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.
Time Frame
Up to 5 years after first patient randomized.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival (OS)
Time Frame
Up to 9 years after first patient randomized
Title
Objective response rate (ORR)
Description
Objective response rate (ORR) per RECIST 1.1 as assessed by BICR
Time Frame
Up to 5 years after first patient randomized
Title
Overall survival (OS) at 24 months
Description
Overall survival (OS) at 24 months
Time Frame
Up to 9 years after first patient randomized
Title
Duration of response (DoR)
Description
Duration of response (DoR) per RECIST 1.1 as assessed by BICR
Time Frame
Up to 5 years after first patient randomized
Title
Progression free survival (PFS) at 6, 12, 18, and 24 months
Description
Progression free survival (PFS) at 6, 12, 18, and 24 months respectively, per RECIST 1.1 as assessed by BICR
Time Frame
From date of randomization until 24 months
Title
Time from randomization to second progression (PFS2)
Description
Time from randomization to second progression (PFS2)
Time Frame
Up to 5 years after first patient randomized
Title
Time from randomization to first date of distant metastasis or death (TTDM)
Description
Time from randomization to first date of distant metastasis or death (TTDM)
Time Frame
Up to 5 years after first patient randomized
Title
Time from randomization to start date of first subsequent therapy (TFST)
Description
Time from randomization to start date of first subsequent therapy (TFST)
Time Frame
Up to 9 years after first patient randomized
Title
Progression free survival (PFS) as assessed by Investigator
Description
Progression free survival (PFS) as assessed by Investigator
Time Frame
Up to 5 years after first patient randomized
Title
IHC analysis of PD-L1 TC expression
Description
IHC analysis of PD-L1 TC expression relative to efficacy outcomes
Time Frame
Up to 5 years after first patient randomized
Title
Concentration of Durvalumab
Description
To assess the Pharmacokinetics of Durvalumab when in combination with Monalizumab or Oleclumab - serum peak and trough concentrations
Time Frame
From date of randomization until 3 months after date of last IP dose
Title
Anti-drug antibodies (ADAs)
Description
The immunogenicity of durvalumab, oleclumab, and monalizumab as assessed by presence of anti-drug antibodies (ADAs)
Time Frame
From date of randomization until 3 months after date of last IP dose
Title
Time to deterioration in pulmonary symptoms (TTFCD)
Description
Time to deterioration in pulmonary symptoms (TTFCD)
Time Frame
Up to 5 years after last patient randomized
Title
Concentration of Oleclumab
Description
To assess the Pharmacokinetics of Oleclumab when in combination with Durvulumab - serum peak and trough concentrations
Time Frame
From date of randomization until 3 months after last dose of IP
Title
Concentration of Monalizumab
Description
To assess the Pharmacokinetics of Monalizumab when in combination with Durvalumab - serum peak and trough concentrations
Time Frame
From date of randomization until 3 months after last dose of IP
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Participant must be ≥ 18 years at the time of screening.
Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
Provision of a tumour tissue sample obtained prior to CRT
Documented tumour PD-L1 status by central lab
Documented EGFR and ALK wild-type status (local or central).
Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
WHO performance status of 0 or 1 at randomization
Adequate organ and marrow function
EXCLUSION CRITERIA:
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease.
Mixed small cell and non-small cell lung cancer histology.
Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the past 6 months prior to randomization.
Active or prior documented autoimmune or inflammatory disorders (with exceptions)
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Barlesi, MD
Organizational Affiliation
Gustave Roussy, Cancer Campus, Grand Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Waterloo
State/Province
Iowa
ZIP/Postal Code
50703
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55812
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Middletown
State/Province
New York
ZIP/Postal Code
10941
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Richland
State/Province
Washington
ZIP/Postal Code
99352
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Elizabeth Vale
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gosford
ZIP/Postal Code
2250
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
South Brisbane
ZIP/Postal Code
4101
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
St Albans
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
St. Leonards
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30380-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Florianópolis
ZIP/Postal Code
88034-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fortaleza
ZIP/Postal Code
60336-232
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jaú
ZIP/Postal Code
17210-120
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Recife
ZIP/Postal Code
52010-075
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01323-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Uberlândia
ZIP/Postal Code
38408-150
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vitoria
ZIP/Postal Code
29043-260
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Anyang
ZIP/Postal Code
455000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
101199
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beijing
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510062
Country
China
Individual Site Status
Terminated
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510700
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310002
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
133500
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230031
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jieyang
ZIP/Postal Code
522000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650118
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Linhai
ZIP/Postal Code
317000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nantong
ZIP/Postal Code
226361
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Neijiang
ZIP/Postal Code
641000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ningbo
ZIP/Postal Code
315100
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Shaoguan
ZIP/Postal Code
512027
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430071
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhanjiang
ZIP/Postal Code
524001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou City
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhongshan
ZIP/Postal Code
528403
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zhuhai
ZIP/Postal Code
519000
Country
China
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
080012
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
080020
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bogota D.C.
ZIP/Postal Code
110131
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bogotá
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Medellin
ZIP/Postal Code
050034
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valledupar
ZIP/Postal Code
200001
Country
Colombia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Avignon Cedex 9
ZIP/Postal Code
84918
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Besançon Cedex
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lorient cedex
ZIP/Postal Code
56322
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Marseille Cedex 20
ZIP/Postal Code
13015
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montpellier
ZIP/Postal Code
34298
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris Cedex 5
ZIP/Postal Code
75005
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rouen
ZIP/Postal Code
76031
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toulouse CEDEX 09
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Georgsmarienhuette
ZIP/Postal Code
49124
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guetersloh
ZIP/Postal Code
33332
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hannover
ZIP/Postal Code
30459
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Himeji-shi
ZIP/Postal Code
670-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
730-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kashiwa
ZIP/Postal Code
227-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Natori-shi
ZIP/Postal Code
981-1293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Niigata-shi
ZIP/Postal Code
951-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
980-0873
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tokushima-shi
ZIP/Postal Code
770-8503
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toon-shi
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wakayama-shi
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Changwon-si
ZIP/Postal Code
51353
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suwon-si
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Concepción
ZIP/Postal Code
12125
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15038
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 29
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 32
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
Lima 34
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Trujillo
Country
Peru
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Koszalin
ZIP/Postal Code
75-581
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-569
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tomaszów Mazowiecki
ZIP/Postal Code
97-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1400-048
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Yekaterinburg
ZIP/Postal Code
620036
Country
Russian Federation
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei 112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan City
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40000
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lampang
ZIP/Postal Code
52000
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Muang
ZIP/Postal Code
22000
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Muang
ZIP/Postal Code
50200
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mueang
ZIP/Postal Code
20000
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Naimuang
ZIP/Postal Code
30000
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Goztepe Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Karsiyaka
ZIP/Postal Code
35575
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kharkiv Region
ZIP/Postal Code
61018
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kropyvnytskyi
ZIP/Postal Code
25011
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Uzhgorod
ZIP/Postal Code
88000
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zaporizhzhia
ZIP/Postal Code
69000
Country
Ukraine
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH4 2XR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Research Site
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poole
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rhyl
ZIP/Postal Code
LL18 5UJ
Country
United Kingdom
Individual Site Status
Suspended
Facility Name
Research Site
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wolverhampton
ZIP/Postal Code
WV10 OQP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh city
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Recruiting
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 requests will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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 deidentified 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
Learn more about this trial
A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
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