Nonsmall Cell Lung CancerPRECENTNCT02988141
EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC
An observational study of Nonsmall Cell Lung Cancer, run by Jianxing He.
Trial summary
A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients with Advanced EGFRm+ NSCLC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall Cell Lung Cancer
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Feb 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: EGFR mutation positive patients with paired tissue and blood samples
Who may be able to join
- Provision of informed consent prior to any study specific procedures.
- Male or female patients aged 18 years and older.
- Histological confirmation of stage IIIB/IV NSCLC.
- Documented EGFR mutation positive .
- WHO Performance Status 0, 1 or 2
Who cannot join
- Any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study.
- Previous (within 6 months) or current treatment with AZD9291.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC
A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients with Advanced EGFRm+ NSCLC
Read the detailed description
Patients with EGFR mutation and presented secondary resistance to prior first-generation EGFR-TKI should have received biopsy of at least on progressed lesions and are able to provide tissues for pathological examination and NGS testing.All enrolled patients will be followed up to clinical outcome (treatments, tumor response, survival, etc).
- Conditions
- Nonsmall Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
The biomarker profile of EGFR-TKI resistance
Measured: Baseline
Secondary outcomes (1)
The concordance, sensitivity and specificity in paired blood and tissue samples
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startMar 2017 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianxing He
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor-investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Jian Xing HE, MD, Principal investigator, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988141
- Sponsor's protocol ID
- CCTC1601
- Acronym
- PRECENT
- Status last verified
- Jan 2017
- First submitted
- 7 Dec 2016
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC
- ClinicalTrials.gov ID
- NCT02988141
- Acronym / sponsor ID
- PRECENT / CCTC1601
- Conditions
- Nonsmall Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jianxing HeUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Mar 2017 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 9 Dec 2016 (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.
A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients with Advanced EGFRm+ NSCLC
Detailed description
Patients with EGFR mutation and presented secondary resistance to prior first-generation EGFR-TKI should have received biopsy of at least on progressed lesions and are able to provide tissues for pathological examination and NGS testing.All enrolled patients will be followed up to clinical outcome (treatments, tumor response, survival, etc).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- EGFR mutation positive patients with paired tissue and blood samples
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific procedures.
- Male or female patients aged 18 years and older.
- Histological confirmation of stage IIIB/IV NSCLC.
- Documented EGFR mutation positive .
- WHO Performance Status 0, 1 or 2
Key exclusion criteria (2 listed)
- Any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study.
- Previous (within 6 months) or current treatment with AZD9291.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The biomarker profile of EGFR-TKI resistance
Time frame: Baseline
1 secondary outcome
The concordance, sensitivity and specificity in paired blood and tissue samples
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Individual participant dataSharing planned: No
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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.
Jian Xing HE, MD principal investigator
China
Questions about this trial
What is this clinical trial studying?
An observational study of Nonsmall Cell Lung Cancer, run by Jianxing He.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Xing HE, MD (86-20-83062338 ext. 0, yxy701@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The biomarker profile of EGFR-TKI resistance (time frame: Baseline). 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 20 Jan 2017.