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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
Not applicable
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
Not applicable
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
Interventional diagnostic, international, multicenter and non-comparative study of EGFR mutation status in aNSCLC patients (locally advanced and/or metastatic disease) with adenocarcinoma and non-adenocarcinoma histologies. It will be conducted in Asia Pacific and Russia and will assess the current status of EGFR mutation testing, and the concordance of EGFR mutation status derived from tumour samples and blood based circulating free DNA.
Trial website
https://clinicaltrials.gov/study/NCT01788163
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01788163