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

NCT02575560 | Completed DMC

• 1 other identifier: QCH200501
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

EGFR-TKI Resistant Mutation

Keywords

Progression-Free Survival

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival Time (PFS)

  an average 1 year

Secondary Outcomes (2)

• Overall Response Rate(ORR)

  an average half year

• Overall Survival Time (OS)

  an average 2 year

Study Arms (1)

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

Interventions

history data OTHER

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

weekly use erolotinib vs history data

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

histological confirmed local advanced or metastatic lung adenocarcinoma with EGFR mutation diagnosed by 2nd generation sequence system.

You may qualify if:

• 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.

You may not qualify if:

• liver function (ALT, AST) and renal function 2 times higher than normal limit; IPD; uncontrolled diarrhea; severe anemia.

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

Location

Study Officials

• ketao lan

  Qingdao Central Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 14, 2015
• Study Start: October 1, 2015
• Primary Completion: September 30, 2017
• Study Completion: December 31, 2017
• Last Updated: February 14, 2018

Record last verified: 2015-10

Locations

CN (1)