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

Dr. Soetomo General Hospital

Status: Unknown

Conditions: Non-Small-Cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02755337

Dr. Soetomo General Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No Healthy Volunteers

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