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

NCT ID: NCT02575560

Last Updated: 2018-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-01

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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EGFR-TKI Resistant Mutation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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weekly use erolotinib vs history data

Drug: erolotinib erolotinib 1050mg, oral, once a week, continues to disease progression or death or stop by physician

history data

Intervention Type OTHER

history data of PFS after 1st line or second line theray

Interventions

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history data

history data of PFS after 1st line or second line theray

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qingdao Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Youxin Ji

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ketao lan

Role: STUDY_CHAIR

Qingdao Central Hospital

Locations

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Qingdao Central Hospital

Qingdao, Shandong, China

Site Status

Countries

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China

Other Identifiers

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QCH200501

Identifier Type: -

Identifier Source: org_study_id

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