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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06417814
Registration number
NCT06417814
Ethics application status
Date submitted
13/05/2024
Date registered
16/05/2024
Date last updated
16/07/2025
Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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Scientific title
A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)
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Secondary ID [1]
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2024-511362-37-00
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Secondary ID [2]
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D516KC00001
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Universal Trial Number (UTN)
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Trial acronym
TROPION-Lung15
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
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 - Dato-DXd
Treatment: Drugs - Osimertinib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Experimental: Group 1: Dato-DXd + Osimertinib Combination Therapy - Participants will receive Dato-DXd 6 mg/kg as IV infusion Q3W on Day 1 of every 21-day cycle, and osimertinib 80 milligrams (mg) once daily (QD) orally, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.
Experimental: Group 2: Dato-DXd Monotherapy - Participants will receive Dato-DXd 6 milligrams per kilogram (mg/kg) as intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of every 21-day cycle, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or other discontinuation criterion is met.
Experimental: Group 3: Platinum-based Doublet Chemotherapy - Participants will receive pemetrexed 500 milligrams per meter square (mg/m2) in combination with carboplatin (AUC5) or cisplatin 75 mg/m2 as IV infusion Q3W for 4 cycles followed by pemetrexed maintenance 500 mg/m2 as IV infusion Q3W, until RECIST v1.1-defined radiological progression by investigator, unacceptable toxicity, or another discontinuation criterion is met.
Treatment: Drugs: Dato-DXd
Dato-DXd will be administered as IV infusion.
Treatment: Drugs: Osimertinib
Osimertinib will be administered orally.
Treatment: Drugs: Pemetrexed
Pemetrexed will be administered as IV infusion.
Treatment: Drugs: Carboplatin
Carboplatin will be administered as IV infusion.
Treatment: Drugs: Cisplatin
Cisplatin will be administered as IV 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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Progression free Survival (PFS)
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Assessment method [1]
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PFS is defined as the time from randomization to Blinded Independent Central Review (BICR)-assessed progression using RECIST v1.1 or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinical progression.
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Timepoint [1]
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Up to 2.5 years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as time from randomization until the date of death due to any cause.
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Timepoint [1]
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Up to 3.5 years
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Secondary outcome [2]
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Central Nervous System Progression-free Survival (CNS PFS)
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Assessment method [2]
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CNS PFS is defined as the time from randomization to BICR confirmed progression in the CNS or death due to any cause, regardless of whether the participant withdraws from study therapy, receives other anti-cancer therapy, or clinically progresses prior to BICR confirmed CNS modified RECIST v1.1 progression.
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Timepoint [2]
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Up to 2.5 years
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Secondary outcome [3]
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Objective Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by BICR per RECIST v1.1.
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Timepoint [3]
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Up to 2.5 years
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Secondary outcome [4]
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Duration of Response (DoR)
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Assessment method [4]
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DoR is defined as the time from the date of first documented response until date of documented progression per RECIST v1.1, as assessed by BICR or death due to any cause.
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Timepoint [4]
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Up to 2.5 years
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Secondary outcome [5]
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Progression-free Survival-2 (PFS-2)
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Assessment method [5]
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PFS2 is defined as the time from randomization to the earliest of the progression event (following the initial investigator assessed progression), after first subsequent therapy, or death.
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Timepoint [5]
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Up to 3.5 years
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Secondary outcome [6]
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Objective Response Rate (ORR) Using CNS Modified RECIST v1.1
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Assessment method [6]
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ORR is defined as the percentage of participants who have a confirmed CR or confirmed PR, using CNS modified RECIST v1.1.
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Timepoint [6]
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Up to 2.5 years
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Secondary outcome [7]
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Duration of Response (DoR) Using CNS Modified RECIST v1.1
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Assessment method [7]
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DoR is defined as the time from the date of first documented response until date of documented progression or death due to any cause using CNS modified RECIST v1.1.
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Timepoint [7]
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Up to 2.5 years
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Secondary outcome [8]
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Time to Deterioration in Pulmonary Symptoms
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Assessment method [8]
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Time to deterioration (in pulmonary symptoms \[dyspnea, cough, and chest pain\]) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.
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Timepoint [8]
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Up to 3.5 years
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Secondary outcome [9]
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Time to Deterioration in Physical Functioning
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Assessment method [9]
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Time to deterioration in physical functioning as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function short form 8c will be evaluated. Time to deterioration (in physical functionating) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.
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Timepoint [9]
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Up to 3.5 years
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Secondary outcome [10]
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Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL)
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Assessment method [10]
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Time to deterioration in GHS/QoL as measured by the GHS/QoL scale from EORTC IL172 will be reported. Time to deterioration (in GHS/QoL) is defined as the time from randomization until the date of deterioration. Deterioration is defined as change from baseline that reaches a meaningful change threshold.
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Timepoint [10]
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Up to 3.5 years
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Secondary outcome [11]
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Pharmacokinetics (PK) of Dato-DXd
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Assessment method [11]
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Concentration of Dato-DXd, total anti-TROP2 antibody and DXd in plasma.
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Timepoint [11]
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Up to 3.5 years
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Secondary outcome [12]
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Immunogenicity of Dato-DXd
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Assessment method [12]
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Presence of antidrug antibody (ADAs) for Dato-DXd (confirmatory results: positive or negative, titers).
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Timepoint [12]
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Up to 3.5 years
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed non-squamous NSCLC.
* Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKis] sensitivity [Ex19del, L858R, G719X, S768I, or L861Q], either alone or in combination with other EGFR mutations, which may include T790M).
* Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.
* Less than or equal to (<=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).
* At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.
* World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate bone marrow reserve and organ function within 7 days before randomization.
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Minimum age
18
Years
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Maximum age
No limit
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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
* Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization.
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.
* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD/pneumonitis, cardiac disease.
* Has significant third-space fluid retention (example [eg.], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.
* History of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.
* Unstable spinal cord compression and/or unstable brain metastases.
* Participants with symptomatic brain metastases (including leptomeningeal involvement).
* Clinically significant corneal disease.
* Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections.
* Has known human immunodeficiency virus (HIV) infection that is not well controlled.
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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
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
4/10/2024
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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
29/05/2028
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Actual
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Sample size
Target
630
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Fitzroy
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Research Site - Heidelberg
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Research Site - Woodville
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Recruitment hospital [10]
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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VIC3065 - Fitzroy
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Recruitment postcode(s) [2]
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3084 - Heidelberg
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2217 - Kogarah
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2170 - Liverpool
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6009 - Nedlands
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2444 - Port Macquarie
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Recruitment postcode(s) [7]
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2065 - St Leonards
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Recruitment postcode(s) [8]
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2145 - Westmead
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Recruitment postcode(s) [9]
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5011 - Woodville
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Recruitment postcode(s) [10]
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4102 - Woolloongabba
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Recruitment outside Australia
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Thessaloniki
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Hong Kong
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Shatin
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India
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Amravati
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India
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Bhubaneswar
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India
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Hyderabad
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India
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Kolhapur
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India
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Mumbai
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India
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Mysuru
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India
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Namakkal
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India
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Pune
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India
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India
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India
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India
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Thane
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India
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Trivandrum
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India
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Varanasi
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Bari
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Italy
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Milano
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Italy
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Misterbianco
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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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Orbassano
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Italy
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Padova
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Italy
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Italy
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Perugia
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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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Fukuoka-shi
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Japan
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Hiroshima-shi
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Japan
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Iruma-Gun
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Japan
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Iwakuni-shi
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Japan
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Kobe
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Japan
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Koto-ku
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Japan
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Kumamoto-shi
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Japan
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Kyoto-shi
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Japan
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Matsuyama-shi
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Japan
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Nagoya-shi
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Japan
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Niigata-shi
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Japan
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Osaka-Sayama
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Japan
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Osaka-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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Utsunomiya-shi
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Japan
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Wakayama-shi
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Japan
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Yokohama-shi
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Korea, Republic of
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Busan
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Korea, Republic of
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Chungcheongbuk-do
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Jinju-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-si
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Malaysia
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Alor Setar
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Malaysia
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Cheras
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Malaysia
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Johor Bahru
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
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Malaysia
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Perai
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Malaysia
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Petaling Jaya
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Malaysia
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Selangor
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Amersfoort
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Bacolod
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Philippines
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Manila
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Philippines
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Quezon
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Philippines
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San Juan
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Poland
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Katowice
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Krakow
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Poznan
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Poland
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Lódz
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Portugal
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Braga
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Portugal
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Porto
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Romania
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Craiova
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Singapore
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Barakaldo
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Barcelona
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El Palmar
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Spain
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L'Hospitalet de Llobregat
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Spain
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La Coruna
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Spain
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Madrid
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Spain
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Majadahonda
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Malaga
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Spain
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Palma de Mallorca
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Pamplona
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Spain
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Santander
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Spain
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Santiago De Compostela-Coruña
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Valladolid
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Taiwan
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Taiwan
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Taiwan
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New Taipei
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Taiwan
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Taichung
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Taiwan
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Taiwan
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Tainan
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Thailand
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Bangkok
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Chiang Mai
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Thailand
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Hat Yai
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Thailand
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Khon-Kaen
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Thailand
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Pathumthani
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United Kingdom
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Birmingham
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesbrough
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Vietnam
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State/province [217]
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Hanoi
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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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Country
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Other collaborator category [1]
0
0
Commercial sector/industry
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Name [1]
0
0
Daiichi Sankyo
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Address [1]
0
0
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Country [1]
0
0
Query!
Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).
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Trial website
https://clinicaltrials.gov/study/NCT06417814
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
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Address
0
0
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
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Address
0
0
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Country
0
0
Query!
Phone
0
0
1-877-240-9479
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Fax
0
0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
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/NCT06417814
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