EGFR Mutation Positive Non-small Cell Lung CancerNCT01776684
Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis
A study testing EGFR TKIs (gefitinib, erlotinib, afatinib, et al) in people with EGFR Mutation Positive Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- EGFR Mutation Positive Non-small Cell Lung Cancer
- What is being tested?
- EGFR TKIs (gefitinib, erlotinib, afatinib, et al)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to May 2015
- 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
- 1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent
Who cannot join
- 1. Active infection 2. Active bleeding
Trial locations and contacts
1 site in 1 country.
Myung-Ju Ahn, M.D., Ph.D. contact
Jong-Mu Sun, M.D., Ph.D. contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Myung-Ju Ahn, M.D., Ph.D., silkahn@skku.edu
About this study
Official title: Detection of Resistance Genes From Serially Collected Plasma DNA in Non-small Cell Lung Cancer Patients Harboring EGFR Activating Mutation Who Are Being Treated With EGFR TKIs
To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.
- Being tested
- EGFR TKIs (gefitinib, erlotinib, afatinib, et al)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGFR TKIs (gefitinib, erlotinib, afatinib, et al)Drug
| Study group | Role | What they receive |
|---|---|---|
| EGFR positive arm | Experimental | Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21) Receives: Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al) |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of resistant gene
To evaluate the efficiency of castPCR method for detection of resistance genes, especially, T790M mutation from serially collected plasma DNA in non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startJun 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutation Positive Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Myung-Ju Ahn, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776684
- Sponsor's protocol ID
- 2011-10-054
- Status last verified
- Jan 2013
- First submitted
- 23 Jan 2013
- Last updated
- 28 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Resistance Genes From Serially Collected Plasma DNA in Non-small Cell Lung Cancer Patients Harboring EGFR Activating Mutation Who Are Being Treated With EGFR TKIs
- ClinicalTrials.gov ID
- NCT01776684
- Acronym / sponsor ID
- 2011-10-054
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jun 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 28 Jan 2013 (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.
To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EGFR positive arm | Experimental | Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent
Key exclusion criteria (1 listed)
- 1. Active infection 2. Active bleeding
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 TKIs (gefitinib, erlotinib, afatinib, et al) | Drug | EGFR positive arm |
Primary outcome
detection of resistant gene
Time frame: 24 months
To evaluate the efficiency of castPCR method for detection of resistance genes, especially, T790M mutation from serially collected plasma DNA in non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
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Osimertinib Plus Savolitinib in EGFRm+/MET+ NSCLC Following Prior Osimertinib
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A Clinical Study Comparing the Efficacy and Safety of Befotertinib Versus Icotinib in Patients With Previously Untreated EGFR-sensitive Mutation-positive Non-small Cell Lung Cancer With ECOG Score ≥2
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RecruitingPhase 1/2
Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive
NSCLC (Non-small Cell Lung Cancer)
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.
Myung-Ju Ahn, M.D., Ph.D. contact
Jong-Mu Sun, M.D., Ph.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EGFR TKIs (gefitinib, erlotinib, afatinib, et al) in people with EGFR Mutation Positive Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Myung-Ju Ahn, M.D., Ph.D. (silkahn@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of resistant gene (time frame: 24 months). 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 28 Jan 2013.