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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05261399
Registration number
NCT05261399
Ethics application status
Date submitted
15/02/2022
Date registered
2/03/2022
Date last updated
4/06/2024
Titles & IDs
Public title
Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment
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Scientific title
A Phase III, Randomised, Open-Label Study of Savolitinib in Combination With Osimertinib Versus Platinum-Based Doublet Chemotherapy in Participants With EGFR Mutated, MET-Overexpressed and/or Amplified, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed on Treatment With Osimertinib (SAFFRON).
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Secondary ID [1]
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2024-511169-12-00
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Secondary ID [2]
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D5087C00001
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Universal Trial Number (UTN)
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Trial acronym
SAFFRON
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma
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Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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0
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Savolitinib
Treatment: Drugs - Osimertinib
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Cisplatin
Treatment: Drugs - Carboplatin
Active Comparator: Chemotherapy - Pemetrexed (500 mg/m2) with either cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21-day cycles (Q3W) for 4 cycles, followed by pemetrexed maintenance (500 mg/m2) Q3W
Experimental: Savolitinib + Osimertinib - 300 mg savolitinib BID plus 80 mg osimertinib QD
Treatment: Drugs: Savolitinib
300 mg savolitinib (3 × 100 mg tablets twice daily) Administrative route : oral
Treatment: Drugs: Osimertinib
80 mg osimertinib
(1 × 80 mg tablet once daily) Administrative route : oral
Treatment: Drugs: Pemetrexed
Pemetrexed (500 mg/m2) Administrative route : IV infusion
Treatment: Drugs: Cisplatin
Cisplatin (75 mg/m2) or Administrative route : IV infusion
Treatment: Drugs: Carboplatin
Carboplatin (AUC5) Administrative route : 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) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib.
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Assessment method [1]
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Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
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Timepoint [1]
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Approximately 55 months post first subject randomized
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Secondary outcome [1]
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Overall Survival (OS) /savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
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Assessment method [1]
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Defined as time from randomisation until the date of death due to any cause.
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Timepoint [1]
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Approximately 55 months post first subject randomized.
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Secondary outcome [2]
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Progression-free survival (PFS) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
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Assessment method [2]
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Defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
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Timepoint [2]
0
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Approximately 55 months post first subject randomized
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Secondary outcome [3]
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Overall Survival (OS) / savolitinib in combination with osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed by IHC, locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
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Assessment method [3]
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Defined as time from randomisation until the date of death due to any cause.
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Timepoint [3]
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Approximately 55 months post first subject randomized
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Secondary outcome [4]
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Objective response rate (ORR) savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
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Assessment method [4]
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ORR defined as the proportion of participants who have BOR of a CR or PR, as determined by BICR per RECIST 1.1.
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Timepoint [4]
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Approximately 55 months post first subject randomized
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Secondary outcome [5]
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Participant-reported pulmonary core symptoms / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed on osimertinib.
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Assessment method [5]
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TTD in pulmonary core symptoms (dyspnoea, cough, and chest pain) as measured by the NSCLC-SAQ.
TTD is defined as the time from randomisation until the date of deterioration.
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Timepoint [5]
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Approximately 55 months post first subject randomized
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Secondary outcome [6]
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Pharmacokinetics (PK) of savolitinib.
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Assessment method [6]
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Plasma concentrations of savolitinib and its metabolites.
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Timepoint [6]
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6 weeks after last patient dosed
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Secondary outcome [7]
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Disease control rate (DCR) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
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Assessment method [7]
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DCR defined as the proportion of participants who have BOR of a CR, PR, or stable disease, as determined by BICR per RECIST 1.1.
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Timepoint [7]
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Approximately 55 months post first subject randomized
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Secondary outcome [8]
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Time to discontinuation of treatment (TDT) or death / savolitinib + osimertinib vs platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on osimertinib
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Assessment method [8]
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TDT or death is defined as the time from date of randomisation to the earlier of the date of study intervention discontinuation or death.
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Timepoint [8]
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Approximately 55 months post first subject randomized
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Secondary outcome [9]
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Tumor shrinkage / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
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Assessment method [9]
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Tumour shrinkage defined as percentage change in tumour size in accordance with RECIST 1.1.
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Timepoint [9]
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Approximately 55 months post first subject randomized
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Secondary outcome [10]
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Duration of response (DoR) / savolitinib + osimertinib versus platinum doublet chemotherapy in participants with EGFR mutated, MET-overexpressed and/or amplified locally advanced or metastatic NSCLC who have progressed on treatment with osimertinib.
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Assessment method [10]
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DoR defined as the time from the date of first documented response until date of documented progression per RECIST 1.1 as assessed by BICR, or death in the absence of disease progression.
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Timepoint [10]
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Approximately 55 months post first subject randomized
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Eligibility
Key inclusion criteria
- Provision of signed and dated written ICF prior to any mandatory and non-mandatory
study-specific procedures, sampling and analyses.
- Participant must be =18 years (= 19 years of age in South Korea) at the time of
signing the informed consent. All genders are permitted.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC which
is not amenable to curative therapy.
- Must have at least one documented sensitising EGFR mutation: exon19 deletion, L858R
mutation, and/or T790M.
- Documented radiologic progression on first- or second-line treatment with osimertinib
as the most recent anti-cancer therapy.
- Mandatory provision of FFPE tumour tissue.
- MET overexpression and/or amplification in tumour specimen collected following
progression on prior osimertinib treatment.
- Measurable disease as defined by RECIST 1.1.
- Adequate haematological, liver, renal and cardiac functions, and coagulation
parameters.
- ECOG performance status of 0 or 1.
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Minimum age
18
Years
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Maximum age
130
Years
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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
- Predominant squamous NSCLC, and small cell lung cancer.
- Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.
- Prior or current treatment with savolitinib or another MET inhibitors.
- Spinal cord compression or brain metastases, unless asymptomatic and are stable.
- History or active leptomeningeal carcinomatosis.
- Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 and prior
platinum-therapy related Grade 2 neuropathies with the exception of alopecia and
haemoglobin = 9.0 g/dL.
- Active/unstable cardiac diseases currently or within the last 6 months, clinically
significant ECG abnormalities, and/or factors/medications that may affect QTc
intervals.
- History of liver cirrhosis of any origin and clinical stage; or history of other
serious liver disease or chronic disease with relevant liver involvement.
- Known serious active infection including, but not limited to, tuberculosis, or HIV,
HBV or HCV or gastrointestinal disease.
- Receipt of live attenuated vaccine (including against COVID-19) within 30 days prior
to the first dose of study intervention.
- Past medical history of ILD, drug-induced ILD, radiation pneumonitis, which required
steroid treatment, or any evidence of clinically active ILD.
- Participants currently receiving medications or herbal supplements known to be strong
inducers of cytochrome P450 (CYP)3A4 or strong inhibitors of CYP1A2.
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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
3/08/2022
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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
17/12/2026
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Actual
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Sample size
Target
324
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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 - Clayton
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Research Site - Fremantle
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Recruitment hospital [3]
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Research Site - Geelong
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Recruitment hospital [4]
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Research Site - Liverpool
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Recruitment hospital [5]
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Research Site - Southport
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Recruitment hospital [6]
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Research Site - Waratah NSW
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Recruitment hospital [7]
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Research Site - Westmead
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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6160 - Fremantle
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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2170 - Liverpool
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Recruitment postcode(s) [5]
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4215 - Southport
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Recruitment postcode(s) [6]
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2298 - Waratah NSW
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Recruitment postcode(s) [7]
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2145 - Westmead
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Recruitment outside Australia
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California
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Florida
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Illinois
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Massachusetts
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Michigan
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Ohio
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Tennessee
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Argentina
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Berazategui
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Caba
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Cordoba
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La Rioja
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Homburg
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Germany
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Immenhausen
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Germany
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Germany
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Muenster
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Germany
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München
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Germany
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Stuttgart
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Germany
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Wangen
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Athens
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Chaidari
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Heraklion
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Larissa
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Greece
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Rio
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Greece
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HKG
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Hong Kong
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Israel
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Israel
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Israel
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Israel
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Israel
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Tel Aviv
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Milan
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Modena
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Italy
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Monserrato
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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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Parma
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Italy
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Perugia
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Italy
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Peschiera Del Garda
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Italy
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Roma
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Italy
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Treviso
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Fukuoka-shi
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Japan
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Hirosaki-shi
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Japan
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Japan
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Iwakuni-shi
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Japan
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Kanazawa-shi
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Japan
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Kashiwa
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Japan
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Kobe-shi
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Japan
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Kobe
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Japan
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Japan
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Kurume-shi
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Japan
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Matsuyama
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Japan
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Japan
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Okayama-shi
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Japan
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Osaka-shi
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Japan
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Japan
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Sakai-shi
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Japan
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Japan
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Japan
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Sunto-gun
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Japan
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Japan
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Japan
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Yokohama-shi
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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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Incheon
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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
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Korea, Republic of
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Ulsan
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Malaysia
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Kota Bharu
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Malaysia
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Malaysia
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Pulau Pinang
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Malaysia
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Sabah
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Amsterdam
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Bacolod
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Philippines
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Cebu
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Philippines
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Philippines
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San Juan
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Lódz
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Russian Federation
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Singapore
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Badajoz
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Spain
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Spain
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Spain
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Cordoba
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Spain
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Girona
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Spain
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La Coruña
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Spain
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Spain
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Majadahonda
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Spain
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Málaga
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Spain
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Spain
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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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Switzerland
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Bern
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Switzerland
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Winterthur
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Switzerland
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Chiayi
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Taiwan
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Hsinchu
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Taiwan
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Taiwan
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Liuying
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Taiwan
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Taichung
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0
Taiwan
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Taipei 112
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0
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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Thailand
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Chiang Mai
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Country [216]
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Thailand
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Dusit
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Country [217]
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Thailand
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Hat Yai
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Country [218]
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Thailand
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Muang
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Thailand
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Mueang Chanthaburi
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Country [220]
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Izmir
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United Kingdom
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Bristol
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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London
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Country [229]
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United Kingdom
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Manchester
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United Kingdom
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Newport
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Country [231]
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United Kingdom
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Reading
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0
United Kingdom
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Wolverhampton
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Vietnam
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Can Tho
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Vietnam
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Hanoi City
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Vietnam
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Hanoi
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0
Vietnam
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Ho Chi Minh city
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Country [237]
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0
Vietnam
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State/province [237]
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0
Ho Chi Minh
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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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Ethics approval
Ethics application status
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Summary
Brief summary
Clinical study to investigate the efficacy and safety of savolitinib in combination with
osimertinib versus platinum-based doublet chemotherapy in participants with EGFR mutated,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC who have progressed
on treatment with Osimertinib.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT05261399
Query!
Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Shun Lu, Prof,MD,PhD,
Query!
Address
0
0
Shanghai Chest Hospital, Shanghai JiaoTong University, #241 Huai Hai Road (west), Shanghai, China.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
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Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-240-9479
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Fax
0
0
Query!
Email
0
0
[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05261399
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