NSCLCNCT01697163
De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors
An observational study of NSCLC, run by Severance Hospital.
Trial summary
This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes". Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- NSCLC
- How many people
- 155 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Sep 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSCLC patient with EGFR mutation
Who may be able to join
- Pathologically proven unresectable NSCLC
- 20 years of age or older
- Planned treatment with Iressa®
- Patients with activating EGFR mutation (del 19, L858R)
- Available detailed smoking history
- Available tissue samples (archival tissue) for mutational or molecular analysis (representative paraffin block or unstained sections from tumor diagnostic specimen are mandatory)
Show all 9Show fewer
- Available blood sample
- At least one lesion that is measurable according to the RECIST 1.1 criteria by CT or MRI
- Written informed consent
Who cannot join
- More than 3rd line treatment
- Previously treated with other EGFR-TKI
- Life expectancy of less than 12 weeks
- Pregnant or lactating female
- Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti cancer treatment.
- Unsuitable patient in this treatment as determined by doctor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pilot Study to Identify the Mechanism of De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors (EGFR-TKIs) in NSCLC With EGFR Mutation.
This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.
Read the detailed description
Investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with activating EGFR mutations, and available tissue sample for DNA extraction.
- Conditions
- NSCLC
- Keywords
- De Novo Resistance, Iressa, EGFR mutation, lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Iressa | Lung cancer patients with EGFR mutation |
What is being measured
The primary outcome is the main question the study is designed to answer.
hazard rates of PFS
The primary objective is to compare hazard rates of PFS in patients treated with Iressa between with and without any molecular aberrancy in EGFR-downstream genes/proteins.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies 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
- Time perspective
- Prospective
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Joo Hang Kim, Severance Hospital
- Investigators
- Joo Hang Kim, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01697163
- Sponsor's protocol ID
- ISSIRES0067
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2012
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Lim SM, Kim HR, Cho EK, Min YJ, Ahn JS, Ahn MJ, Park K, Cho BC, Lee JH, Jeong HC, Kim EK, Kim JH. Targeted sequencing identifies genetic alterations that confer primary resistance to EGFR tyrosine kinase inhibitor (Korean Lung Cancer Consortium). Oncotarget. 2016 Jun 14;7(24):36311-36320. doi: 10.18632/oncotarget.8904.
PubMed 27121209
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Identify the Mechanism of De Novo Resistance to Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors (EGFR-TKIs) in NSCLC With EGFR Mutation.
- ClinicalTrials.gov ID
- NCT01697163
- Acronym / sponsor ID
- ISSIRES0067
- Conditions
- NSCLC
- Keywords
- De Novo Resistance, Iressa, EGFR mutation, lung cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 2 Oct 2012 (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.
This study is based on the following hypothesis "De novo resistance to EGFR-TKI in EGFR mutation positive patients is related with mutations in EGFR downstream genes".
Investigators will prospectively collect genomic DNA and clinical data regarding treatment outcomes to EGFR-TKI in NSCLC patients with activating EGFR mutations. Investigators will sequence candidate mutations of EGFR downstream genes and analyze c-met gene amplification and protein expression in PTEN, HGF, and IGFR. To identify genetic mutations, amplification, and protein over expression as predictive markers of treatment outcomes, investigators analyzed the association of treatment outcomes with the presence of genetic alteration or protein over expression. Investigators will attempt to identify biomarkers that are able to predict de novo resistance to EGFR-TKI in EGFR mutated NSCLC.
Detailed description
Investigators will prospectively enroll patients who match the following criteria: pathologically proven unresectable NSCLC, planning to treat with EGFR-TKI, patients with activating EGFR mutations, and available tissue sample for DNA extraction.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iressa | – | –Lung cancer patients with EGFR mutation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC patient with EGFR mutation
Key inclusion criteria (9 listed)
- Pathologically proven unresectable NSCLC
- 20 years of age or older
- Planned treatment with Iressa®
- Patients with activating EGFR mutation (del 19, L858R)
- Available detailed smoking history
Key exclusion criteria (6 listed)
- More than 3rd line treatment
- Previously treated with other EGFR-TKI
- Life expectancy of less than 12 weeks
- Pregnant or lactating female
- Any unresolved toxicity greater than CTC grade 2 (version 4.0) from previous anti cancer treatment.
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
hazard rates of PFS
Time frame: 1year
The primary objective is to compare hazard rates of PFS in patients treated with Iressa between with and without any molecular aberrancy in EGFR-downstream genes/proteins.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2012.
- Derived from this study: PubMed 27121209Lim SM, Kim HR, Cho EK, Min YJ, Ahn JS, Ahn MJ, Park K, Cho BC, Lee JH, Jeong HC, Kim EK, Kim JH. Targeted sequencing identifies genetic alterations that confer primary resistance to EGFR tyrosine kinase inhibitor (Korean Lung Cancer Consortium). Oncotarget. 2016 Jun 14;7(24):36311-36320. doi: 10.18632/oncotarget.8904.
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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.
Joo Hang Kim, MD, PhD principal investigator
Severance Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Severance Hospital.
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 9 inclusion and 6 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 2 Oct 2012. 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 Joo Hang Kim, MD, PhD (82-2-2228-8131, kjhang@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hazard rates of PFS (time frame: 1year). 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 NCT01697163, which also lists 1 linked publication.
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 2 Oct 2012.