Weekly Use First-generation EGFR-TKI in the Treatment of EGFR-TKI Acquired Resistance Non-small Cell Lung Cancer (NSCLC)

February 13, 2018 updated by: Youxin Ji, Qingdao Central Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266042
        • Qingdao Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

histological confirmed local advanced or metastatic lung adenocarcinoma with EGFR mutation diagnosed by 2nd generation sequence system.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
weekly use erolotinib vs history data
Drug: erolotinib erolotinib 1050mg, oral, once a week, continues to disease progression or death or stop by physician
Other: history data
history data of PFS after 1st line or second line theray

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival Time (PFS)
Time Frame: an average 1 year
an average 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate(ORR)
Time Frame: an average half year
an average half year
Overall Survival Time (OS)
Time Frame: an average 2 year
an average 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Central Hospital

Investigators

  • Study Chair: ketao lan, Qingdao Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 9, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QCH200501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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