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

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ClinicalTrials.gov Identifier: NCT02575560
Recruitment Status : Completed
First Posted : October 14, 2015
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Youxin Ji, Qingdao Central Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
EGFR-TKI Resistant Mutation Other: history data

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
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
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)
Study Start Date : October 1, 2015
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival Time (PFS) [ Time Frame: an average 1 year ]

Secondary Outcome Measures :
  1. Overall Response Rate(ORR) [ Time Frame: an average half year ]
  2. Overall Survival Time (OS) [ Time Frame: an average 2 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
histological confirmed local advanced or metastatic lung adenocarcinoma with EGFR mutation diagnosed by 2nd generation sequence system.
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575560


Locations
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China, Shandong
Qingdao Central Hospital
Qingdao, Shandong, China, 266042
Sponsors and Collaborators
Qingdao Central Hospital
Investigators
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Study Chair: ketao lan Qingdao Central Hospital
More Information
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Responsible Party: Youxin Ji, Director, Qingdao Central Hospital
ClinicalTrials.gov Identifier: NCT02575560    
Other Study ID Numbers: QCH200501
First Posted: October 14, 2015    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: October 2015
Keywords provided by Youxin Ji, Qingdao Central Hospital:
Progression-Free Survival
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases