Clinical trial NCT01788163: Asia Pacific and Russia Diagnostic Study for EGFR Testing
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: EGFR Mutation Status in aNSCLC Patients
Keywords: EGFR
aNSCLC
mutation status
diagnostic study
Russia
China
Asia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: A diagnostic study to determine the prevalence of EGFR mutations in Asian and Russian patients with advanced NSCLC of Adenocarcinoma and Non-adenocarcinoma histologies

Eligibility criteria: 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

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

Primary outcomes:
measure: Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status
timeFrame: At Screening
measure: Tumour EGFR Mutation by Subtype
timeFrame: At Screening
measure: Tumour EGFR Mutation Status by Histology
timeFrame: At Screening
measure: Overall Plasma EGFR Mutation Status
timeFrame: At Screening
measure: Plasma EGFR Mutation by Subtype
timeFrame: At Screening
measure: Plasma EGFR Mutation Status by Histology
timeFrame: At Screening
Secondary outcomes:
measure: Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples
timeFrame: At Screening
measure: Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples
timeFrame: At Screening
measure: Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples
timeFrame: At Screening
measure: Tumour EGFR Mutation Testing
timeFrame: At Screening
measure: Tumour EGFR Mutation Testing Rates
timeFrame: At Screening
measure: Tumour EGFR Mutation Testing Turnaround Time
timeFrame: At Screening
measure: Plasma EGFR Mutation Testing
timeFrame: At Screening
measure: Plasma EGFR Mutation Testing Rates
timeFrame: At Screening
measure: Plasma EGFR Mutation Testing Turnaround Time
timeFrame: At Screening
measure: Demographics and Disease Characteristics by Tumour EGFR Mutation Status
timeFrame: At Screening
measure: Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation
timeFrame: At Screening
measure: Number of Organs With Metastasis by Tumour EGFR Mutation Status
timeFrame: At Screening
measure: Demographics and Disease Characteristics by Plasma EGFR Mutation Status
timeFrame: At Screening
measure: Time Since First NSCLC Diagnosis by Plasma EGFR Mutation
timeFrame: At Screening
measure: Number of Organs With Metastasis by Plasma EGFR Mutation Status
timeFrame: At Screening
measure: First Line Treatment Choice by Asia Pacific Country
timeFrame: At Screening
measure: First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
timeFrame: At Screening
Other outcomes:
Locations:
city: Campbelltown
country: Australia
facility: Research Site
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Research Site
state: New South Wales
city: Concord
country: Australia
facility: Research Site
state: New South Wales
city: Tamworth
country: Australia
facility: Research Site
state: New South Wales
city: Tweed Heads
country: Australia
facility: Research Site
state: New South Wales
city: Wahroonga
country: Australia
facility: Research Site
state: New South Wales
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Research Site
state: Queensland
city: Murdoch
country: Australia
facility: Research Site
state: Western Australia
city: Beijing
country: China
facility: Research Site
city: Changsha
country: China
facility: Research Site
city: Changzhou
country: China
facility: Research Site
city: Chengdu City
country: China
facility: Research Site
city: Chengdu
country: China
facility: Research Site
city: Chongqing
country: China
facility: Research Site
city: Foshan City
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Hangzhou City
country: China
facility: Research Site
city: Hangzhou
country: China
facility: Research Site
city: Nanjing
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Suzhou City
country: China
facility: Research Site
city: Taiyuan
country: China
facility: Research Site
city: Wuhan City
country: China
facility: Research Site
city: Zhengzhou
country: China
facility: Research Site
city: Jakarta
country: Indonesia
facility: Research Site
city: Surabaya
country: Indonesia
facility: Research Site
city: Cheongju
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Belgorod
country: Russian Federation
facility: Research Site
city: Birobidzhan
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Chita
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Khabarovsk
country: Russian Federation
facility: Research Site
city: Khanty-Mansisk
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Lipetsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orel
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Pyatigorsk
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Surgut
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Velikiy Novgorod
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Yakutsk
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Yuzhno-Sakhalinsk
country: Russian Federation
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Khon Kaen
country: Thailand
facility: Research Site
city: Patumwan Bangkok
country: Thailand
facility: Research Site
Study officials:
affiliation: AstraZeneca, PHB
name: Rose McCormack, PhD
role: STUDY_DIRECTOR
References: