Back to resultsA Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy (LATIFY)
Primary Purpose
Advanced or Metastatic Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ceralasertib
Durvalumab
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Advanced or Metastatic Non-Small Cell Lung Cancer focused on measuring Durvalumab, Ceralasertib, Docetaxel, Lung cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
- Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
- Documented radiological PD whilst on or after receiving the most recent treatment regimen.
- Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
- Adequate organ function and marrow reserve
- Minimum life expectancy of 12 weeks.
- Body weight > 30 kg and no cancer-associated cachexia.
- Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).
Exclusion Criteria:
- Participant with mixed SCLC and NSCLC histology.
- 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.
- Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
- Active or prior documented autoimmune or inflammatory disorders.
- Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
Participants:
- Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
- All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
- Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
- Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
- Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
- Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group A: Ceralasertib plus durvalumab combination therapy
Group B: Docetaxel monotherapy
Arm Description
Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.
Participants will be administered docetaxel (standard of care) administered intravenously.
Outcomes
Primary Outcome Measures
Overall Survival (OS)
The superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel will be demonstrated by assessment of OS (HR with 95% CI and p-value) in participants with advanced NSCLC after second- or third-line therapy and without actionable genomic alterations. OS is defined as time from randomisation until the date of death due to any cause.
Secondary Outcome Measures
Progression-Free Survival (PFS)
PFS will be defined as the time from the date of randomisation until the date of objective PD.
Objective Response Rate (ORR)
ORR is defined as the proportion of participant who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1.
Duration of Response (DoR)
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1.
Time To Response (TTR)
TTR is defined as the time from randomisation until the date of first documented objective response.
Disease Control Rate (DCR)
DCR at 18 weeks is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) for at least 17 weeks.
Time to second progression or death (PFS2)
Time from randomisation to PFS2 will be defined as the time from the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.
Overall Survival (OS) at 12 months
OS is defined as time from randomisation until the data of death due to any cause.
Time To Deterioration (TTD) of health-related quality of life (QoL)
TTD is defined as the time from randomisation until the date of first confirmed deterioration.
TTD of physical function
TTD in physical functioning is measured by the EORTC QLQ-C30 Physical Function subscale of the EORTC QLQ-C30.
Plasma concentrations for ceralasertib plus durvalumab combination therapy
The PK plasma concentration of ceralasertib when administered in combination with durvalumab will be assessed.
Number of participants with Adverse Evens (AEs)
The safety and tolerability of ceralasertib plus durvalumab combination therapy as compared with docetaxel will be assessed.
Full Information
NCT ID
NCT05450692
First Posted
July 6, 2022
Last Updated
October 6, 2023
Sponsor
AstraZeneca
Collaborators
Parexel
1. Study Identification
Unique Protocol Identification Number
NCT05450692
Brief Title
A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy
Acronym
LATIFY
Official Title
A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
May 22, 2025 (Anticipated)
Study Completion Date
May 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Parexel
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 study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
Detailed Description
This study will consist of two treatment arms (Groups A and B).
Participants will be randomised in a 1:1 ratio to one of the two treatment groups:
Group A: Ceralasertib plus durvalumab combination therapy Each 28-day cycle will begin with ceralasertib administered orally followed by durvalumab administered intravenously.
Group B: Docetaxel monotherapy Each 21-day cycle will begin with the administration of docetaxel.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced or Metastatic Non-Small Cell Lung Cancer
Keywords
Durvalumab, Ceralasertib, Docetaxel, Lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
580 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A: Ceralasertib plus durvalumab combination therapy
Arm Type
Experimental
Arm Description
Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.
Arm Title
Group B: Docetaxel monotherapy
Arm Type
Active Comparator
Arm Description
Participants will be administered docetaxel (standard of care) administered intravenously.
Intervention Type
Drug
Intervention Name(s)
Ceralasertib
Intervention Description
Participants will receive ceralasertib oral tablets.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Intervention Description
Participants will receive durvalumab as an intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Participants will received docetaxel as an intravenous infusion.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
The superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel will be demonstrated by assessment of OS (HR with 95% CI and p-value) in participants with advanced NSCLC after second- or third-line therapy and without actionable genomic alterations. OS is defined as time from randomisation until the date of death due to any cause.
Time Frame
Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years)
Secondary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
PFS will be defined as the time from the date of randomisation until the date of objective PD.
Time Frame
Up to 3 years
Title
Objective Response Rate (ORR)
Description
ORR is defined as the proportion of participant who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1.
Time Frame
Up to 3 years
Title
Duration of Response (DoR)
Description
DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1.
Time Frame
Up to 3 years
Title
Time To Response (TTR)
Description
TTR is defined as the time from randomisation until the date of first documented objective response.
Time Frame
Up to 3 years
Title
Disease Control Rate (DCR)
Description
DCR at 18 weeks is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) for at least 17 weeks.
Time Frame
At Week 18
Title
Time to second progression or death (PFS2)
Description
Time from randomisation to PFS2 will be defined as the time from the randomisation to the earliest of the progression event (following the initial progression), subsequent to first subsequent therapy or death.
Time Frame
Up to 3 years
Title
Overall Survival (OS) at 12 months
Description
OS is defined as time from randomisation until the data of death due to any cause.
Time Frame
At 12 months
Title
Time To Deterioration (TTD) of health-related quality of life (QoL)
Description
TTD is defined as the time from randomisation until the date of first confirmed deterioration.
Time Frame
Up to 3 years
Title
TTD of physical function
Description
TTD in physical functioning is measured by the EORTC QLQ-C30 Physical Function subscale of the EORTC QLQ-C30.
Time Frame
Up to 3 years
Title
Plasma concentrations for ceralasertib plus durvalumab combination therapy
Description
The PK plasma concentration of ceralasertib when administered in combination with durvalumab will be assessed.
Time Frame
Up to 3 years
Title
Number of participants with Adverse Evens (AEs)
Description
The safety and tolerability of ceralasertib plus durvalumab combination therapy as compared with docetaxel will be assessed.
Time Frame
Up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
Documented radiological PD whilst on or after receiving the most recent treatment regimen.
Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in combination.
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
Adequate organ function and marrow reserve
Minimum life expectancy of 12 weeks.
Body weight > 30 kg and no cancer-associated cachexia.
Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).
Exclusion Criteria:
Participant with mixed SCLC and NSCLC histology.
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.
Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
Active or prior documented autoimmune or inflammatory disorders.
Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
Participants:
Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.
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
Facility Information:
Facility Name
Research Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
1058
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1280AEB
Country
Argentina
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Pergamino
ZIP/Postal Code
B2700CPM
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000KZE
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Viedma
ZIP/Postal Code
R8500JYJ
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Elizabeth Vale
ZIP/Postal Code
5112
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lismore
ZIP/Postal Code
2480
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Murdoch
ZIP/Postal Code
6150
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
Wendouree
ZIP/Postal Code
3355
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Libramont-Chevigny
ZIP/Postal Code
6800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Fortaleza
ZIP/Postal Code
60810-180
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90110-270
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salvador
ZIP/Postal Code
40170-110
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
09323-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
VSZ 4E6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 7P2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baoding
ZIP/Postal Code
071000
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
100044
Country
China
Individual Site Status
Not yet 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
Not yet recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Deyang
ZIP/Postal Code
618000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ganzhou
ZIP/Postal Code
341000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Linyi
ZIP/Postal Code
276000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
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
Qingdao
ZIP/Postal Code
266071
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taiyuan
ZIP/Postal Code
030000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300052
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
430000
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
430079
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Xingtai
ZIP/Postal Code
054000
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yantai
ZIP/Postal Code
264000
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
ZIP/Postal Code
450003
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
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clamart Cedex
ZIP/Postal Code
92140
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Creteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montpellier
ZIP/Postal Code
34070
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nantes cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75005
Country
France
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Herblain Cedex
ZIP/Postal Code
44805
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint-Quentin cedex
ZIP/Postal Code
02321
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vantoux
ZIP/Postal Code
57070
Country
France
Individual Site Status
Recruiting
Facility Name
Research Site
City
Villefranche Sur Saone
ZIP/Postal Code
69655
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
Berlin
ZIP/Postal Code
12351
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Karlsruhe
ZIP/Postal Code
76137
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kempten
ZIP/Postal Code
87439
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Moers
ZIP/Postal Code
47441
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Münster
ZIP/Postal Code
48147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
King's Park
ZIP/Postal Code
150001
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tun Mun
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Jaipur
ZIP/Postal Code
302017
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Surat
ZIP/Postal Code
395002
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cork
ZIP/Postal Code
T12 DV56
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Dublin 4
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Dublin
ZIP/Postal Code
D09 V2N0
Country
Ireland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Limerick
ZIP/Postal Code
V94 F858
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Livorno
ZIP/Postal Code
57124
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
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Parma
ZIP/Postal Code
43126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8677
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hiroshima-shi
ZIP/Postal Code
730-8518
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kurashiki-shi
ZIP/Postal Code
710-8602
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
Matsuyama-shi
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagasaki-shi
ZIP/Postal Code
852-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
460-0001
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
Sakai-shi
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sapporo-shi
ZIP/Postal Code
003-0804
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
Sunto-gun
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toyoake-shi
ZIP/Postal Code
470-1192
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
236-0051
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
240-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-8515
Country
Japan
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
Seoul
ZIP/Postal Code
03181
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
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
138-736
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
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zutphens
ZIP/Postal Code
7207 AE
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-219
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-727
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-826
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Skórzewo
ZIP/Postal Code
60-185
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bucuresti
ZIP/Postal Code
031422
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400641
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Constanta
ZIP/Postal Code
900591
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Craiova
ZIP/Postal Code
200385
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Floresti
ZIP/Postal Code
407280
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oradea
ZIP/Postal Code
410469
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300166
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300239
Country
Romania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Belgrad
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
A Coruña
ZIP/Postal Code
15009
Country
Spain
Individual Site Status
Recruiting
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
08041
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
Castello de la Plana
ZIP/Postal Code
12002
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hospitalet deLlobregat
ZIP/Postal Code
08907
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
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Orense
ZIP/Postal Code
32005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Servilla
ZIP/Postal Code
41014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taoyuan City
ZIP/Postal Code
333423
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yunlin
ZIP/Postal Code
640
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guildford
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Stevenage
ZIP/Postal Code
SG1 4AB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
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 request 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 Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy
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