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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02755337
Acronym
EVALUATE
Enrollment
70
Registered
2016-04-28
Start date
2016-01-31
Completion date
2016-12-31
Last updated
2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Cancer

Keywords

adenocarcinoma, non-adenocarcinoma

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.

Interventions

None listed

Sponsors

Dr. Soetomo General Hospital
Lead SponsorOTHER_GOV

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Indonesia

Contacts

Primary ContactLaksmi Wulandari, MD, PhD
laksmigts@yahoo.co.id+628123019591
Backup ContactAnna Febriani, MD
annafebriani@yahoo.com+62818703492

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026