EGFR-TKI Resistant MutationNCT02575560
Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)
An observational study of EGFR-TKI Resistant Mutation, run by Qingdao Central Hospital at 1 site in China.
Trial summary
EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- EGFR-TKI Resistant Mutation
- What is being tested?
- history data
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2015to 31 Dec 2017
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: histological confirmed local advanced or metastatic lung adenocarcinoma with EGFR mutation diagnosed by 2nd generation sequence system.
Who may be able to join
- NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.
Who cannot join
- liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Dose Weekly Use First-generation EGFR-TKI Instead of Daily Regular Dose in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)
EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.
Read the detailed description
1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.
- Conditions
- EGFR-TKI Resistant Mutation
- Being tested
- history data
- Keywords
- Progression-Free Survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
history dataOther
history data of PFS after 1st line or second line theray
| Study group | Role | What they receive |
|---|---|---|
| weekly use erolotinib vs history data | Drug: erolotinib erolotinib 1050mg, oral, once a week, continues to disease progression or death or stop by physician Receives: Other: history data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Time (PFS)
Measured: an average 1 year
Secondary outcomes (2)
Overall Response Rate(ORR)
Measured: an average half year
Overall Survival Time (OS)
Measured: an average 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study start1 Oct 2015
- Primary completion30 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR-TKI Resistant MutationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qingdao Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youxin Ji, Qingdao Central Hospital
- Investigators
- ketao lan, Study chair, Qingdao Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575560
- Sponsor's protocol ID
- QCH200501
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 14 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Weekly Use First-generation EGFR-TKI Instead of Daily Regular Dose in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02575560
- Acronym / sponsor ID
- QCH200501
- Conditions
- EGFR-TKI Resistant Mutation
- Keywords
- Progression-Free Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Qingdao Central HospitalUniversity, hospital or other
- Study start
- 1 Oct 2015
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 14 Oct 2015 (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.
EGFR-TKI is the main is the first line therapy for local advanced or metastatic non-small cell lung cancer with EGFR gene mutation. The median progression free survival time is around 11 months with the first generation EGFR-TKI. Patients with acquired resistance with first generation EGFR-TKI usually with EGFR exon 20 mutation (T790M). Change the drug administration maybe prolong patients PFS and evently prolong OS.
Detailed description
1st generation EGFR-TKI has reversible binding to EGFR, it also bind to T790M in a high dose which is account about 60% patients acquired resistance to the drug. Resistance patients may be benefit to a bolus drug use to block T790M gene.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| weekly use erolotinib vs history data | – | Other: history dataDrug: erolotinib erolotinib 1050mg, oral, once a week, continues to disease progression or death or stop by physician |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- histological confirmed local advanced or metastatic lung adenocarcinoma with EGFR mutation diagnosed by 2nd generation sequence system.
Key inclusion criteria (1 listed)
- NSCLC with EGFR mutation progressed after first generation EGFR-TKI, or progressed after chemotherapy and 1st generation EGFR-TKI or progressed after 1st generation EGFR-TKI and chemotherapy. Expected survival more than 3 months with a ECOG ≤3.
Key exclusion criteria (1 listed)
- liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.
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 |
|---|---|---|
| history datahistory data of PFS after 1st line or second line theray | Other | weekly use erolotinib vs history data |
Primary outcome
Progression Free Survival Time (PFS)
Time frame: an average 1 year
2 secondary outcomes
Overall Response Rate(ORR)
Time frame: an average half year
Overall Survival Time (OS)
Time frame: an average 2 year
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 14 Feb 2018.
Related trials for EGFR-TKI Resistant Mutation
Active, not recruitingPhase 1/2
Phase 1/2 Study of Silevertinib (BDTX-1535) in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations
Non-Small Cell Lung Cancer, Advanced Non-Small Cell Squamous Lung Cancer
Not yet recruitingPhase 2
Comparative ¹⁸F-FDG and ⁶⁸Ga-MY6349 PET/CT Imaging for Assessing TROP2 ADC Therapeutic Efficacy in EGFR-TKI Resistant Advanced NSCLC
NSCLC, EGFR Activating Mutation
RecruitingPhase 1/2
Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer Patients
Non-small Cell Lung Cancer, EGFR Gene Mutation
RecruitingObservational study
Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)
Lung Cancer, Non-small Cell, EGFR Gene Mutation
RecruitingPhase 2
Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial
Non-small Cell Lung Cancer, EGFR Activating 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.
ketao lan study chair
Qingdao Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EGFR-TKI Resistant Mutation, run by Qingdao Central Hospital at 1 site in China.
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 14 Feb 2018. 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 China. 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?
Progression Free Survival Time (PFS) (time frame: an average 1 year). 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 14 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.