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

Completed

• Conditions: EGFR-TKI Resistant Mutation
• Interventions: Other: history data

• Registration Number: NCT02575560
• Lead Sponsor: Qingdao Central Hospital

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.

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 Timeline

• Status Verified: 2015-10
• Study Start: 2015-10-01
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-14
• Primary Completion: 2017-09-30
• Study Completion: 2017-12-31
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
weekly use erolotinib vs history data	history data	Drug: erolotinib erolotinib 1050mg, oral, once a week, continues to disease progression or death or stop by physician

Primary Outcome Measures

Name	Time	Method
Progression Free Survival Time (PFS)	an average 1 year

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate(ORR)	an average half year
Overall Survival Time (OS)	an average 2 year

Trial Locations

Locations (1)

Qingdao Central Hospital; 🇨🇳 Qingdao, Shandong, China