EGFR Mutation Status in aNSCLC PatientsIGNITENCT01788163

Asia Pacific and Russia Diagnostic Study for EGFR Testing

A study testing EGFR mutation test in people with EGFR Mutation Status in aNSCLC Patients, run by AstraZeneca at 71 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: EGFR Mutation Status in aNSCLC Patients
What is being tested?: EGFR mutation test
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,500 participants
Where: 71 sitesin 9 countries
Study dates: 27 Feb 2013to 20 Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

71 sites in 9 countries.

Country

City, postcode or hospital

71 sites in 9 countries

Russia35 sites

Research Site
Arkhangelsk
Research Site
Barnaul
Research Site
Belgorod
Research Site
Birobidzhan
Research Site
Chelyabinsk
Research Site
Chita
Research Site
Irkutsk
Research Site
Izhevsk
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Khabarovsk
Research Site
Khanty-Mansiysk
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Lipetsk
Research Site
Moscow
Research Site
Novosibirsk
Research Site
Obninsk
Research Site
Omsk
Research Site
Oryol
Research Site
Perm
Research Site
Pyatigorsk
Research Site
Rostov-on-Don
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Samara
Research Site
Surgut
Research Site
Tula
Research Site
Ufa
Research Site
Velikiy Novgorod
Research Site
Vladivostok
Research Site
Volgograd
Research Site
Yakutsk
Research Site
Yaroslavl
Research Site
Yuzhno-Sakhalinsk

Other trials in Russia

China14 sites

Research Site
Beijing
Research Site
Changsha
Research Site
Changzhou
Research Site
Chengdu
Research Site
Chongqing
Research Site
Foshan
Research Site
Guangzhou
Research Site
Hangzhou
Research Site
Nanjing
Research Site
Shanghai
Research Site
Suzhou
Research Site
Taiyuan
Research Site
Wuhan
Research Site
Zhengzhou

Other trials in China

Australia9 sites

Research Site
Brisbane, Queensland
Research Site
Campbelltown, New South Wales
Research Site
Coffs Harbour, New South Wales
Research Site
Concord, New South Wales
Research Site
Murdoch, Western Australia
Research Site
Tamworth, New South Wales
Research Site
Tweed Heads, New South Wales
Research Site
Wahroonga, New South Wales
Research Site
Woolloongabba, Queensland

Other trials in Australia

South Korea3 sites

Research Site
Cheongju-si
Research Site
Daegu
Research Site
Seoul

Other trials in South Korea

Taiwan3 sites

Research Site
Kaohsiung City
Research Site
Tainan
Research Site
Taipei

Other trials in Taiwan

Thailand3 sites

Research Site
Chiang Mai
Research Site
Khon Kaen
Research Site
Patumwan Bangkok

Other trials in Thailand

Indonesia2 sites

Research Site
Jakarta
Research Site
Surabaya

Other trials in Indonesia

Malaysia1 site

Research Site
Kuala Lumpur

Other trials in Malaysia

Singapore1 site

Research Site
Singapore

Other trials in Singapore

About this study

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

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.

Read the 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

Conditions: EGFR Mutation Status in aNSCLC Patients
Being tested: EGFR mutation test
Keywords: EGFR, aNSCLC, mutation status, diagnostic study, Russia, China, Asia
Medical subject headings: Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EGFR mutation testGenetic
Also called Determination of EGFR mutation done at the Pathology lab
EGFR mutation being tested in tissue and blood

Study groups in NCT01788163
Study group	Role	What they receive
Locally advanced/metastatic NSCLC pats.	Other	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) Receives: Genetic: EGFR mutation test

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status
The 95% Confidence intervals were calculated using Clopper Pearson method for each country.
Measured: At Screening
Tumour EGFR Mutation by Subtype
Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
Measured: At Screening
Tumour EGFR Mutation Status by Histology
Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.
Measured: At Screening
Overall Plasma EGFR Mutation Status
Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.
Measured: At Screening
Plasma EGFR Mutation by Subtype
Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
Measured: At Screening
Plasma EGFR Mutation Status by Histology
Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country
Measured: At Screening

Secondary outcomes (17)

Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples
Plasma samples were only performed in China, Taiwan, South Korea and Russia.
Measured: At Screening
Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples
Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants only include those who had sensitivity and specificity tests performed.
Measured: At Screening
Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples
Plasma samples were only performed in China, Taiwan, South Korea, and Russia. Participants include only those who had Positive and Negative Predictive tests performed.
Measured: At Screening
Tumour EGFR Mutation Testing
Frequencies of tumour EGFR mutation testing practices parameters.
Measured: At Screening
Tumour EGFR Mutation Testing Rates
Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation.
Measured: At Screening
Tumour EGFR Mutation Testing Turnaround Time
Tumour EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.
Measured: At Screening
Plasma EGFR Mutation Testing
Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequencies of plasma EGFR mutation testing practices parameters.
Measured: At Screening
Plasma EGFR Mutation Testing Rates
Testing Success rate is the percentage of subjects with a non-missing test result. Mutation Detection Rate is the percentage of subjects with successful test that detects a mutation. Plasma samples were only performed in China, Taiwan, South Korea and Russia.
Measured: At Screening
Plasma EGFR Mutation Testing Turnaround Time
Plasma samples were only performed in China, Taiwan, South Korea and Russia. Plasma EGFR mutation testing turnaround time is the number of days from the test request to getting the test result.
Measured: At Screening
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.
Measured: At Screening
Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation
Number of months since the first diagnosis of NSCLC from informed consent date.
Measured: At Screening
Number of Organs With Metastasis by Tumour EGFR Mutation Status
Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.
Measured: At Screening
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Correlation of demographic and disease characteristics are summarized by EGFR mutation status with results from a multivariate logistic regression using stepwise forward selection with a 10% significance level for model entry.
Measured: At Screening
Time Since First NSCLC Diagnosis by Plasma EGFR Mutation
Number of months since the first diagnosis of NSCLC from informed consent date.
Measured: At Screening
Number of Organs With Metastasis by Plasma EGFR Mutation Status
Summary of number of organs with metastasis. Only participants with at least 1 organ with metastasis are included.
Measured: At Screening
First Line Treatment Choice by Asia Pacific Country
Measured: At Screening
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Measured: At Screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 201320 Jun 2016

First posted11 Feb 2013 (estimated)
Study start27 Feb 2013
Primary completion25 Aug 2014
Study completion20 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for EGFR Mutation Status in aNSCLC PatientsStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3,500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01788163
Sponsor's protocol ID: D7913C00074
Acronym: IGNITE
Status last verified: May 2017
First submitted: 7 Feb 2013
Last updated: 17 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01788163
Acronym / sponsor ID: IGNITE / D7913C00074
Conditions: EGFR Mutation Status in aNSCLC Patients
Keywords: EGFR, aNSCLC, mutation status, diagnostic study, Russia, China, Asia
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,500 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 27 Feb 2013 (actual)
Primary completion: 25 Aug 2014 (actual)
Study completion: 20 Jun 2016 (actual)
First posted: 11 Feb 2013 (estimated)
Results: Posted 9 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Locally advanced/metastatic NSCLC pats.	Other	Genetic: EGFR mutation testPatients 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EGFR mutation testAlso: Determination of EGFR mutation done at the Pathology labEGFR mutation being tested in tissue and blood	Genetic	Locally advanced/metastatic NSCLC pats.

Primary outcome

Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status
Time frame: At Screening
The 95% Confidence intervals were calculated using Clopper Pearson method for each country.
Tumour EGFR Mutation by Subtype
Time frame: At Screening
Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
Tumour EGFR Mutation Status by Histology
Time frame: At Screening
Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country.
Overall Plasma EGFR Mutation Status
Time frame: At Screening
Plasma samples were only performed in China, Taiwan, South Korea and Russia. The Confidence intervals were calculated using Clopper Pearson method for each country.
Plasma EGFR Mutation by Subtype
Time frame: At Screening
Plasma samples were only performed in China, Taiwan, South Korea and Russia. Frequency distribution of subjects with a positive mutation status by the mutation subtype and country.
Plasma EGFR Mutation Status by Histology
Time frame: At Screening
Only subjects who had a recorded Histological Type of Adenocarcinoma or Non-adenocarcinoma are included. Confidence intervals were calculated using Clopper Pearson method for each country

17 secondary outcomes

Concordance Rate of Comparison of Mutation Status Between Tumour and Plasma Samples
Time frame: At Screening
Sensitivity and Specificity of Comparison of Mutation Status Between Tumour and Plasma Samples
Time frame: At Screening
Predictive Values of Comparison of Mutation Status Between Tumour and Plasma Samples
Time frame: At Screening
Tumour EGFR Mutation Testing
Time frame: At Screening
Tumour EGFR Mutation Testing Rates
Time frame: At Screening
Tumour EGFR Mutation Testing Turnaround Time
Time frame: At Screening
Plasma EGFR Mutation Testing
Time frame: At Screening
Plasma EGFR Mutation Testing Rates
Time frame: At Screening
Plasma EGFR Mutation Testing Turnaround Time
Time frame: At Screening
Demographics and Disease Characteristics by Tumour EGFR Mutation Status
Time frame: At Screening
Time Since First Non-small-cell Lung Carcinoma (NSCLC) Diagnosis by Tumor EGFR Mutation
Time frame: At Screening
Number of Organs With Metastasis by Tumour EGFR Mutation Status
Time frame: At Screening
Demographics and Disease Characteristics by Plasma EGFR Mutation Status
Time frame: At Screening
Time Since First NSCLC Diagnosis by Plasma EGFR Mutation
Time frame: At Screening
Number of Organs With Metastasis by Plasma EGFR Mutation Status
Time frame: At Screening
First Line Treatment Choice by Asia Pacific Country
Time frame: At Screening
First Line Treatment Choice by Asia Pacific Country by Tumour EGFR Mutation Status
Time frame: At Screening

Results and safety

Results posted to the registry on 9 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
China	1,458	1,403
Taiwan	271	271
South Korea	62	62
Australia	71	71
Thailand	94	94
Singapore	102	95
Malaysia	50	49
Indonesia	302	254
Russia	972	956

Primary outcome: Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status

Time frame: At Screening. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	China n = 1391	Taiwan n = 271	South Korea n = 62	Australia n = 58	Thailand n = 87	Singapore n = 100	Malaysia n = 49	Indonesia n = 273	Russia n = 924
Mutation Negative	59.2 (56.6 to 61.8)	52.0 (45.9 to 58.1)	77.4 (65.0 to 87.1)	70.7 (57.3 to 81.9)	71.3 (60.6 to 80.5)	45.0 (35.0 to 55.3)	65.3 (50.4 to 78.3)	57.5 (51.4 to 63.4)	88.1 (85.8 to 90.1)
Mutation Positive	40.8 (38.2 to 43.4)	48.0 (41.9 to 54.1)	22.6 (12.9 to 35.0)	29.3 (18.1 to 42.7)	28.7 (19.5 to 39.4)	55.0 (44.7 to 65.0)	34.7 (21.7 to 49.6)	42.5 (36.6 to 48.6)	11.9 (9.9 to 14.2)

Population analysed: Tumour Evaluable Population

Primary outcome: Tumour EGFR Mutation by Subtype

Time frame: At Screening. Number. Unit: Participants

Measure	China n = 1391	Taiwan n = 271	South Korea n = 62	Australia n = 58	Thailand n = 87	Singapore n = 100	Malaysia n = 49	Indonesia n = 273	Russia n = 924
G719x mutation only	8	1	0	0	2	0	0	0	0
Exon 19 deletion only	283	61	5	12	13	27	7	43	63
Exon 19 deletion +T790M	0	1	0	0	0	0	0	0	0
Exon 19 deletion + other	6	1	0	0	0	5	0	0	8
Exon 19 Other only	2	0	0	0	0	0	0	0	0
T790M only	0	2	0	0	0	0	0	0	0
T790M + other	2	0	0	0	0	0	0	0	0
Exon 20 insertions only	11	2	1	0	2	3	2	0	0

Population analysed: Tumour Evaluable Population

Primary outcome: Tumour EGFR Mutation Status by Histology

Time frame: At Screening. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	China-Adenocarcinoma n = 1026	China-Non-adenocarcinoma n = 361	Taiwan-Adenocarcinoma n = 208	Taiwan-Non-adenocarcinoma n = 61	South Korea-Adenocarcinoma n = 46	South Korea-Non-adenocarcinoma n = 15	Australia-Adenocarcinoma n = 49	Australia-Non-adenocarcinoma n = 7	Thailand-Adenocarcinoma n = 73	Thailand-Non-adenocarcinoma n = 13	Singapore-Adenocarcinoma n = 95	Singapore-Non-adenocarcinoma n = 3	Malaysia-Adenocarcinoma n = 40	Malaysia-Non-adenocarcinoma n = 6	Indonesia-Adenocarcinoma n = 212	Indonesia-Non-adenocarcinoma n = 59	Russia-Adenocarcinoma n = 500	Russia-Non-adenocarcinoma n = 402
Mutation Negative	48.7 (45.6 to 51.8)	88.9 (85.2 to 92.0)	42.8 (36.0 to 49.8)	83.6 (71.9 to 91.8)	69.6 (54.2 to 82.3)	100.0 (78.2 to 100.0)	67.3 (52.5 to 80.1)	85.7 (42.1 to 99.6)	69.9 (58.0 to 80.1)	84.6 (54.6 to 98.1)	43.2 (33.0 to 53.7)	66.7 (9.4 to 99.2)	62.5 (45.8 to 77.3)	83.3 (35.9 to 99.6)	54.7 (47.8 to 61.5)	67.8 (54.4 to 79.4)	82.0 (78.3 to 85.3)	96.3 (93.9 to 97.9)
Mutation Positive	51.3 (48.2 to 54.4)	11.1 (8.0 to 14.8)	57.2 (50.2 to 64.0)	16.4 (8.2 to 28.1)	30.4 (17.7 to 45.8)	0.0 (0.0 to 21.8)	32.7 (19.9 to 47.5)	14.3 (0.4 to 57.9)

Primary outcome: Overall Plasma EGFR Mutation Status

Time frame: At Screening. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	China n = 1421	Taiwan n = 271	South Korea n = 61	Russia n = 941
Mutation Negative	79.3 (77.1 to 81.4)	73.1 (67.4 to 78.3)	86.9 (75.8 to 94.2)	90.8 (88.7 to 92.5)
Mutation Positive	20.7 (18.6 to 22.9)	26.9 (21.7 to 32.6)	13.1 (5.8 to 24.2)	9.2 (7.5 to 11.3)

Population analysed: Plasma Evaluable Population

17 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
China	0 of 0	0 of 0	Not reported
Taiwan	0 of 0	0 of 0	Not reported
South Korea	0 of 0	0 of 0	Not reported
Australia	0 of 0	0 of 0	Not reported
Thailand	0 of 0	0 of 0	Not reported
Singapore	0 of 0	0 of 0	Not reported
Malaysia	0 of 0	0 of 0	Not reported
Indonesia	0 of 0	0 of 0	Not reported
Russia	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
D7913C00074\_CSR\_SynopsisLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rose McCormack, PhD study director

AstraZeneca, PHB

71 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EGFR mutation test in people with EGFR Mutation Status in aNSCLC Patients, run by AstraZeneca at 71 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in Russia, China, Australia, South Korea, Taiwan and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Tumour Epidermal Growth Factor Receptor (EGFR) Mutation Status (time frame: At Screening). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01788163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.