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

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: EGFR-TKI Resistant Mutation
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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)	an average 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qingdao Central Hospital
• Investigators: Study Chair: ketao lan, Qingdao Central Hospital

Study record dates

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: Progression-Free Survival
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: QCH200501