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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05450692
Registration number
NCT05450692
Ethics application status
Date submitted
6/07/2022
Date registered
11/07/2022
Titles & IDs
Public 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
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Scientific 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
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Secondary ID [1]
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2022-000493-26
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Secondary ID [2]
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D533BC00001
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Universal Trial Number (UTN)
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Trial acronym
LATIFY
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic Non-Small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ceralasertib
Treatment: Drugs - Durvalumab
Treatment: Drugs - Docetaxel
Experimental: Group A: Ceralasertib plus durvalumab combination therapy - Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.
Active comparator: Group B: Docetaxel monotherapy - Participants will be administered docetaxel (standard of care) administered intravenously.
Treatment: Drugs: Ceralasertib
Participants will receive ceralasertib oral tablets.
Treatment: Drugs: Durvalumab
Participants will receive durvalumab as an intravenous infusion.
Treatment: Drugs: Docetaxel
Participants will received docetaxel as an intravenous infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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Every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years)
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Secondary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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PFS will be defined as the time from the date of randomisation until the date of objective PD.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Objective Response Rate (ORR)
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Assessment method [2]
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ORR is defined as the proportion of participant who have a Complete Response (CR) or Partial Response (PR) per RECIST 1.1.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Duration of Response (DoR)
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Assessment method [3]
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DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Time To Response (TTR)
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Assessment method [4]
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TTR is defined as the time from randomisation until the date of first documented objective response.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Disease Control Rate (DCR)
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Assessment method [5]
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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.
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Timepoint [5]
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At Week 18
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Secondary outcome [6]
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Time to second progression or death (PFS2)
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Assessment method [6]
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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.
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Timepoint [6]
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Up to 3 years
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Secondary outcome [7]
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Overall Survival (OS) at 12 months
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Assessment method [7]
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OS is defined as time from randomisation until the data of death due to any cause.
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Timepoint [7]
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At 12 months
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Secondary outcome [8]
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Time To Deterioration (TTD) of health-related quality of life (QoL)
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Assessment method [8]
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TTD is defined as the time from randomisation until the date of first confirmed deterioration.
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Timepoint [8]
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Up to 3 years
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Secondary outcome [9]
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TTD of physical function
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Assessment method [9]
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TTD in physical functioning is measured by the EORTC QLQ-C30 Physical Function subscale of the EORTC QLQ-C30.
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Timepoint [9]
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Up to 3 years
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Secondary outcome [10]
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Plasma concentrations for ceralasertib plus durvalumab combination therapy
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Assessment method [10]
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The PK plasma concentration of ceralasertib when administered in combination with durvalumab will be assessed.
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Timepoint [10]
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Up to 3 years
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Secondary outcome [11]
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Number of participants with Adverse Evens (AEs)
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Assessment method [11]
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The safety and tolerability of ceralasertib plus durvalumab combination therapy as compared with docetaxel will be assessed.
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Timepoint [11]
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Up to 3 years
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
130
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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:
1. Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
2. All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
3. 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.
4. 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/09/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
22/08/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
594
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Elizabeth Vale
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Research Site - Lismore
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5112 - Elizabeth Vale
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2480 - Lismore
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6150 - Murdoch
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4101 - South Brisbane
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3355 - Wendouree
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Recruitment postcode(s) [6]
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2500 - Wollongong
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Recruitment outside Australia
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Meldola
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Italy
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Milano
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Italy
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Monza
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Italy
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Napoli
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Italy
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Padova
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Italy
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Parma
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Italy
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Roma
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Italy
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Rozzano
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Italy
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Verona
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Japan
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Bunkyo-ku
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Japan
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Chuo-ku
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Japan
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Hiroshima-shi
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Japan
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Koto-ku
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Niigata-shi
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Japan
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Osaka-shi
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Japan
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Sakai-shi
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Japan
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Sapporo-shi
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Japan
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Sendai-shi
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Japan
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Sunto-gun
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Japan
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Toyoake-shi
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Japan
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Yokohama-shi
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Netherlands
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Heerlen
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Netherlands
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Rotterdam
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Netherlands
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Tilburg
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Netherlands
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Zutphens
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Poland
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Gdansk
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Poland
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Krakow
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Poland
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Kraków
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Poland
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Poznan
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Skórzewo
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Poland
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Torun
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Constanta
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Romania
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Craiova
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Romania
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Floresti
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Romania
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Oradea
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Romania
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Timisoara
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Serbia
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Belgrade
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Serbia
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Belgrad
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Serbia
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Kragujevac
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Spain
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A Coruña
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Spain
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Barcelona
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Spain
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Castello de la Plana
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Spain
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Cordoba
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Spain
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Hospitalet deLlobregat
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
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Malaga
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Spain
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Orense
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Spain
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Palma de Mallorca
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Spain
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Pamplona
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Spain
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Pozuelo de Alarcon
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Sabadell
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Servilla
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Zaragoza
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Taiwan
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Taichung
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Tainan
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Taipei City
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Taiwan
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Yunlin
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United Kingdom
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Bristol
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United Kingdom
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Guildford
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United Kingdom
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Stevenage
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United Kingdom
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Sutton
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United Kingdom
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Other collaborator category [1]
0
0
Commercial sector/industry
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Parexel
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05450692
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
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.
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Available to whom?
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.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05450692