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

EGFR-TKI Resistant Mutation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575560
• Other study ID #: QCH200501
• Status: Completed
• Phase: N/A
• First received: October 8, 2015
• Last updated: February 13, 2018
• Start date: October 1, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: October 2015
• Source: Qingdao Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 31, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR-TKI Resistant Mutation

Intervention

Other:
• history data
history data of PFS after 1st line or second line theray

Locations

Country	Name	City	State
China	Qingdao Central Hospital	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival Time (PFS)		an average 1 year
Secondary	Overall Response Rate(ORR)		an average half year
Secondary	Overall Survival Time (OS)		an average 2 year