Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Carcinoma

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

The purpose of this study is to evaluate ORR (Objective Response Rate) of gefitinib as a second-line therapy for NSCLC patients based on RECIST (Response Evaluation Criteria in Solid Tumors Group) and check up ORR difference by EGFR mutation, gender, smoking history, and type of tumor.

SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients

A Phase IV, Multicenter, Non-randomized, Open-labeled Study to Evaluate the Efficacy of Gefitinib (IRESSA®) as a Second-line Therapy in NSCLC Patients

Primary efficacy endpoint is a change in the proportion of subjects showing overall objective response rate(ORR) from baseline to final tumor assessment point after treatment. As per RECIST, the percentage of subjects indicating PR (partial response) or CR (complete response) will be calculated.

According RECIST criteria, CR(complete response) - the disappearance of all target lesions and 'PR(partial response) - at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameter.

The median months without event of progression disease according to RECIST criteria is analysed.

Patients recorded the presence and severity of 7 symptoms by using the lung cancer subscale(LCS) at FACT-L; shortness of breath, weight loss, clarity of thinking, cough, appetite, chest tightness, and difficulty breathing. Severity was assessed by using 0\~4 scale (0=not at all to 4=very much). A possible score was 0\~28.

The improvement rate defined as change of ≥6 points in overall FACT-L from baseline and the rate of patients who reported the change of points ≥2 in LCS of FACT-L.

The percentage of patients who showed improvement is reported.

An adverse event is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.

AstraZeneca

< 65 years

>= 65 years

Age, Customized

Sex: Female, Male

Positive

Negative

Unknown

Epidermal growth factor receptor (EGFR) mutation analysis, PCR test on exon 18, 19 and 21 of EGFR gene was used.

EGFR mutation status

Never-smoker

Ex-smoker

Regular smoker

Smoking history

Adenocarcinoma

Squamous carcinoma

Other

Tumour history

WHO has 5 grades (0-4), 0 -Fully active, 1-Restricted in strenuous activity, 2- Ambulatory and capable of all self-care, 3-Capable of only limited self-care and 4- Completely disabled.

World Health Organisation (WHO) Performance Status

III A

III B

The tumor node metastasis (TNM) staging system (NSCLC) was used to determine the disease stage. Stage is usually expressed as a number on a scale of 0 through IV - with stage 0 describing non-invasive cancers that remain within their original location and stage IV describing invasive cancers that have spread outside to other parts of the body. Number of patients with different disease stage is reported.

Disease Stage

Hui Jung Sin

Objective Response Rate(ORR)

Period of Progression-Free Survival

Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)

Overall Survival

Adverse Event

Overall Study

Spots Global Cancer Trial Database for SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial