Non Small Cell Lung CancerPIONEERNCT01185314
To Study the Changes in Protein in Lung Cells of Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
A study testing Testing for mutation status in people with Non Small Cell Lung Cancer, run by AstraZeneca at 36 sites in 7 countries.
Trial summary
The purpose of this study is to study the changes in protein in lung cells of Asian patients with advanced non small cell lung cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Testing for mutation status
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,270 participants
- Where
- 36 sitesin 7 countries
- Study dates
- Sep 2010to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytologically confirmed advanced Non small cell lung cancer of adeno histology NSCLC treatment naive Availability of cancer tissue or cytology sample
Who cannot join
- Involvement in the planning and/or conduct of the study Previous enrollment in the present study
Trial locations and contacts
36 sites in 7 countries.
36 sites in 7 countries
China12 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changchun, Jilin
Research Site
Chengdu, Sichuan
Research Site
Guangzhou, Guangdong
Research Site
Jinan, Shandong
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Shijiazhuang, Hebei
Research Site
Taiyuan, Shanxi
Research Site
Tianjin, Tianjin Municipality
Research Site
Wuhan, Hubei
Research Site
Zhengzhou, Henan
India7 sites
Research Site
Chennai, Chennai
Research Site
Kochi, Kerala
Research Site
Kolkata, Kolkata
Research Site
Mumbai, Maharashtra
Research Site
Pune, Maharashtra
Research Site
Rohini, National Capital Territory of Delhi
Research Site
Vadodara, Gujarat
Taiwan6 sites
Research Site
Chiayi City
Research Site
Kaohsiung City
Research Site
Taichung
Research Site
Tainan
Research Site
Taipei
Research Site
Taoyuan
Philippines5 sites
Research Site
Cebu City
Research Site
City of Taguig
Research Site
Manila
Research Site
Pasay
Research Site
Quezon City
Thailand3 sites
Research Site
Bangkok, Bangkok
Research Site
Chiang Mai, Chiang Mai
Research Site
Songkhla, Changwat Songkhla
About this study
Official title: A Molecular Epidemiology Study in Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC) of Adeno Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation Status
The purpose of this study is to study the changes in protein in lung cells of Asian patients with advanced non small cell lung cancer.
Read the detailed description
A molecular epidemiology study in Asian patients with advanced NSCLC of adeno histology to assess EGFR mutation status.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Testing for mutation status
- Keywords
- NSCLC, EGFR mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing for mutation statusProcedure or surgery
EGFR mutation test
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | EGFR mutation testing Receives: Procedure: Testing for mutation status |
What is being measured
The primary outcome is the main question the study is designed to answer.
EGFR mutation status of Asian patients with advanced NSCLC
Measured: Samples will be tested after informed consent. Mutation results will be available within 1-3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Guy Yeoman, MBBS, MFPM, Study director, AstraZenecaRobin Meng, MD, PhD, Study chair, AstraZeneca TaiwanYang Pan-Chyr, MD, PhD, Principal investigator, National Taiwan University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185314
- Sponsor's protocol ID
- D7913L00086
- Acronym
- PIONEER
- Status last verified
- Aug 2011
- First submitted
- 16 Aug 2010
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Molecular Epidemiology Study in Asian Patients With Advanced Non-small Cell Lung Cancer (NSCLC) of Adeno Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation Status
- ClinicalTrials.gov ID
- NCT01185314
- Acronym / sponsor ID
- PIONEER / D7913L00086
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- NSCLC, EGFR mutation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,270 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the changes in protein in lung cells of Asian patients with advanced non small cell lung cancer.
Detailed description
A molecular epidemiology study in Asian patients with advanced NSCLC of adeno histology to assess EGFR mutation status.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Procedure: Testing for mutation statusEGFR mutation testing |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histological or cytologically confirmed advanced Non small cell lung cancer of adeno histology NSCLC treatment naive Availability of cancer tissue or cytology sample
Key exclusion criteria (1 listed)
- Involvement in the planning and/or conduct of the study Previous enrollment in the present study
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 |
|---|---|---|
| Testing for mutation statusEGFR mutation test | Procedure or surgery | 1 |
Primary outcome
EGFR mutation status of Asian patients with advanced NSCLC
Time frame: Samples will be tested after informed consent. Mutation results will be available within 1-3 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
Related trials for Non Small Cell Lung Cancer
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1/2
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Ovarian Cancer, Non-small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
Advanced or Metastatic Non-small Cell Lung Cancer
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
Active, not recruitingPhase 3
REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)
Advanced or Metastatic NSCLS With Exon 20 Insertion Mutation
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.
Guy Yeoman, MBBS, MFPM study director
AstraZeneca
Robin Meng, MD, PhD study chair
AstraZeneca Taiwan
Yang Pan-Chyr, MD, PhD principal investigator
National Taiwan University College of Medicine
36 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing for mutation status in people with Non Small Cell Lung Cancer, run by AstraZeneca at 36 sites in 7 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 1 inclusion and 1 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 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in China, India, Taiwan, Philippines, Thailand and 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EGFR mutation status of Asian patients with advanced NSCLC (time frame: Samples will be tested after informed consent. Mutation results will be available within 1-3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2011; AzTrials last refreshed its copy on 4 Nov 2026.