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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

Research Site

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.

AgeCategoricalOther

Gender, Male/Female

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

EGFR mutation status

Other

Smoking history

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

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

Study Specific Characteristic

Objective Response Rate(ORR)

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

Period of Progression-Free Survival

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.

Quality of life and symptom improvement based on Functional Assessment of Cancer Therapy-Lung (FACT-L)

Overall Survival

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.

Adverse event

Overall Study

The subjects were able to provide sample of EGFR mutation test and the subjects who had positive EGFR results or satisfy more than two condition of adenocarcinoma, female or non smoker were eligible.

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=411&filename=CSR-D7913L00067.pdf

CSR-D7913L00067.pdf

Trial Results Summaries

Contacts

Contact