The Evaluation of Lung Cancer Patient Treated With Epidermal Growth Factor Receptor Tyrosine Kinase

• Conditions: Non-Small-Cell Lung Cancer

• Registration Number: NCT02755337
• Lead Sponsor: Dr. Soetomo General Hospital

Brief Summary

To evaluate Non-Small Cell Lung Cancer (NSCLC) patients clinical profile and the outcome after treatment with Gefitinib in Pulmonary Oncology Outpatient Clinic Dr. Soetomo General Hospital, Surabaya, Indonesia.

Detailed Description

Primary Objective: To determine the efficacy of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Secondary Objective: To evaluate the subjective response of NSCLC patients harboring a positive EGFR mutation who treated with Gefitinib.

Safety Objective: To evaluate the safety and tolerability of Gefitinib in NSCLC patient harboring a positive EGFR mutation.

Study Timeline

• Study Start: 2016-01
• Status Verified: 2016-04
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-27
• Last Update Submitted: 2016-04-27
• Study First Posted: 2016-04-28
• Last Update Posted: 2016-04-28
• Primary Completion: 2016-07
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• NSCLC based on histopathologic examination
• Adenocarcinoma and/or nonadenocarcinoma based on histology examination
• Clinical stadium stage IIIB and IV
• Age 16-70 years old
• Received gefitinib as therapy
• At least completed 2 (two) data sets of RECIST 1.1 evaluations during the study period from January 2013 until July 2015

Exclusion Criteria

• Missing data of any variables of the treatment outcomes in the medical record

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	through study completion, in average of 1 year	Overall Survival (OS) as defined by the date of death certificate given by the attending physician or by other government officials
PFS (Progression Free Survival)	through study completion, in average of 1 year	Progression Free Survival (PFS) as defined by RECIST 1.1 or attending physician's clinical judgement of clinical progression state

Trial Locations

Locations (1)

Dr. Soetomo General Hospital; 🇮🇩 Surabaya, East Java, Indonesia