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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01788163




Registration number
NCT01788163
Ethics application status
Date submitted
7/02/2013
Date registered
11/02/2013
Date last updated
17/05/2017

Titles & IDs
Public title
Asia Pacific and Russia Diagnostic Study for EGFR Testing
Scientific title
A Diagnostic Study to Determine the Prevalence of EGFR Mutations in Asian and Russian Patients With Advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma Histologies
Secondary ID [1] 0 0
D7913C00074
Universal Trial Number (UTN)
Trial acronym
IGNITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
EGFR Mutation Status in aNSCLC Patients 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - EGFR mutation test

Other: Locally advanced/metastatic NSCLC pats. - Patients with locally advanced (stage IIIA/B) or metastatic NSCLC who have not received any local or systemic chemotherapy, and are not eligible for curative treatment (including surgery and chemoradiotherapy)


Treatment: Other: EGFR mutation test
EGFR mutation being tested in tissue and blood
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status
Timepoint [1] 0 0
At Screening
Primary outcome [2] 0 0
Tumour EGFR Mutation by Subtype
Timepoint [2] 0 0
At Screening
Primary outcome [3] 0 0
Tumour EGFR Mutation Status by Histology
Timepoint [3] 0 0
At Screening
Primary outcome [4] 0 0
Overall Plasma EGFR Mutation Status
Timepoint [4] 0 0
At Screening
Primary outcome [5] 0 0
Plasma EGFR Mutation by Subtype
Timepoint [5] 0 0
At Screening
Primary outcome [6] 0 0
Plasma EGFR Mutation Status by Histology
Timepoint [6] 0 0
At Screening
Secondary outcome [1] 0 0
Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples
Timepoint [1] 0 0
At Screening
Secondary outcome [2] 0 0
Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples
Timepoint [2] 0 0
At Screening
Secondary outcome [3] 0 0
Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples
Timepoint [3] 0 0
At Screening
Secondary outcome [4] 0 0
Tumour EGFR Mutation Testing
Timepoint [4] 0 0
At Screening
Secondary outcome [5] 0 0
Tumour EGFR Mutation Testing Rates
Timepoint [5] 0 0
At Screening
Secondary outcome [6] 0 0
Tumour EGFR Mutation Testing Turnaround Time
Timepoint [6] 0 0
At Screening
Secondary outcome [7] 0 0
Plasma EGFR Mutation Testing
Timepoint [7] 0 0
At Screening
Secondary outcome [8] 0 0
Plasma EGFR Mutation Testing Rates
Timepoint [8] 0 0
At Screening
Secondary outcome [9] 0 0
Plasma EGFR Mutation Testing Turnaround Time
Timepoint [9] 0 0
At Screening
Secondary outcome [10] 0 0
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Timepoint [10] 0 0
At Screening
Secondary outcome [11] 0 0
Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation
Timepoint [11] 0 0
At Screening
Secondary outcome [12] 0 0
Number of Organs With Metastasis by Tumour EGFR Mutation Status
Timepoint [12] 0 0
At Screening
Secondary outcome [13] 0 0
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Timepoint [13] 0 0
At Screening
Secondary outcome [14] 0 0
Time Since First NSCLC Diagnosis by Plasma EGFR Mutation
Timepoint [14] 0 0
At Screening
Secondary outcome [15] 0 0
Number of Organs With Metastasis by Plasma EGFR Mutation Status
Timepoint [15] 0 0
At Screening
Secondary outcome [16] 0 0
First Line Treatment Choice by Asia Pacific Country
Timepoint [16] 0 0
At Screening
Secondary outcome [17] 0 0
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Timepoint [17] 0 0
At Screening

Eligibility
Key inclusion criteria
* Histological or cytological confirmed locally advanced NSCLC (stage IIIA/B) not suitable for curative treatment or metastatic (stage IV) NSCLC
* Newly diagnosed patients with locally advanced and/or metastatic NSCLC who are systemic treatment Naive (i.e. no chemotherapy or EGFR-TKI) or patients with recurrent disease who have previously received adjuvant chemotherapy (not including EGFR-TKI)
* Provision of diagnostic cancer tissue or cytology sample upon inclusion (surgical specimen, biopsy sample, or cytology sample is acceptable) and Provision of a routine blood (plasma) sample in China, Russia, Taiwan and Korea
* Patients aged 18 years and older
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
* Evidence of any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study
* Pregnancy or breast-feeding

Study design
Purpose of the study
Diagnosis
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/06/2016
Sample size
Target
Accrual to date
Final
3500
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Research Site - Campbelltown
Recruitment hospital [2] 0 0
Research Site - Coffs Harbour
Recruitment hospital [3] 0 0
Research Site - Concord
Recruitment hospital [4] 0 0
Research Site - Tamworth
Recruitment hospital [5] 0 0
Research Site - Tweed Heads
Recruitment hospital [6] 0 0
Research Site - Wahroonga
Recruitment hospital [7] 0 0
Research Site - Brisbane
Recruitment hospital [8] 0 0
Research Site - Woolloongabba
Recruitment hospital [9] 0 0
Research Site - Murdoch
Recruitment postcode(s) [1] 0 0
- Campbelltown
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Concord
Recruitment postcode(s) [4] 0 0
- Tamworth
Recruitment postcode(s) [5] 0 0
- Tweed Heads
Recruitment postcode(s) [6] 0 0
- Wahroonga
Recruitment postcode(s) [7] 0 0
- Brisbane
Recruitment postcode(s) [8] 0 0
- Woolloongabba
Recruitment postcode(s) [9] 0 0
- Murdoch
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Changsha
Country [3] 0 0
China
State/province [3] 0 0
Changzhou
Country [4] 0 0
China
State/province [4] 0 0
Chengdu City
Country [5] 0 0
China
State/province [5] 0 0
Chengdu
Country [6] 0 0
China
State/province [6] 0 0
Chongqing
Country [7] 0 0
China
State/province [7] 0 0
Foshan City
Country [8] 0 0
China
State/province [8] 0 0
Guangzhou
Country [9] 0 0
China
State/province [9] 0 0
Hangzhou City
Country [10] 0 0
China
State/province [10] 0 0
Hangzhou
Country [11] 0 0
China
State/province [11] 0 0
Nanjing
Country [12] 0 0
China
State/province [12] 0 0
Shanghai
Country [13] 0 0
China
State/province [13] 0 0
Suzhou City
Country [14] 0 0
China
State/province [14] 0 0
Taiyuan
Country [15] 0 0
China
State/province [15] 0 0
Wuhan City
Country [16] 0 0
China
State/province [16] 0 0
Zhengzhou
Country [17] 0 0
Indonesia
State/province [17] 0 0
Jakarta
Country [18] 0 0
Indonesia
State/province [18] 0 0
Surabaya
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Cheongju
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Daegu
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Malaysia
State/province [22] 0 0
Kuala Lumpur
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Arkhangelsk
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Barnaul
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Belgorod
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Birobidzhan
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Chelyabinsk
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Chita
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Irkutsk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Izhevsk
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Kazan
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Kemerovo
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Khabarovsk
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Khanty-Mansisk
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Krasnodar
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Krasnoyarsk
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Lipetsk
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Moscow
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Novosibirsk
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Obninsk
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Omsk
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Orel
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Perm
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Pyatigorsk
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Rostov-on-Don
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Ryazan
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Samara
Country [48] 0 0
Russian Federation
State/province [48] 0 0
St. Petersburg
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Surgut
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Tula
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Ufa
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Velikiy Novgorod
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Vladivostok
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Volgograd
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Yakutsk
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Yaroslavl
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Yuzhno-Sakhalinsk
Country [58] 0 0
Singapore
State/province [58] 0 0
Singapore
Country [59] 0 0
Taiwan
State/province [59] 0 0
Kaohsiung
Country [60] 0 0
Taiwan
State/province [60] 0 0
Tainan City
Country [61] 0 0
Taiwan
State/province [61] 0 0
Tainan
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taipei
Country [63] 0 0
Thailand
State/province [63] 0 0
Chiang Mai
Country [64] 0 0
Thailand
State/province [64] 0 0
Khon Kaen
Country [65] 0 0
Thailand
State/province [65] 0 0
Patumwan Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rose McCormack, PhD
Address 0 0
AstraZeneca, PHB
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


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 are available at https://clinicaltrials.gov/study/NCT01788163