Trial Outcomes & Findings for SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients (NCT NCT00608868)

Last Updated: 2012-09-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

156 participants

Primary outcome timeframe

Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)

Results posted on

2012-09-28

Participant Flow

From January 2007 to July 2008, 156 subjects were enrolled from 11 centers in Korea. First subject in date: 17 January 2007. Last subject last visit(Data cut off) date: 2 January 2009.

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.

Participant milestones

Participant milestones
Measure	Gefitinib gefitinib tablet 250 mg orally
Overall Study STARTED	156
Overall Study Enrolled	156
Overall Study Safety Population	154
Overall Study Treatment Completed	141
Overall Study Intention to Treat (ITT) Population	138
Overall Study Per Protocol (PP) Population	121
Overall Study COMPLETED	141
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Gefitinib gefitinib tablet 250 mg orally
Overall Study Withdrawal by Subject	7
Overall Study Protocol Violation	3
Overall Study Lost to Follow-up	2
Overall Study Adverse Event	1
Overall Study Physician Decision	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefitinib n=138 Participants gefitinib tablet 250 mg orally
Age, Customized < 65 years	72 participants n=5 Participants
Age, Customized >= 65 years	66 participants n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
EGFR mutation status Positive	59 Participants n=5 Participants
EGFR mutation status Negative	50 Participants n=5 Participants
EGFR mutation status Unknown	29 Participants n=5 Participants
Smoking history Never-smoker	117 Participants n=5 Participants
Smoking history Ex-smoker	17 Participants n=5 Participants
Smoking history Regular smoker	4 Participants n=5 Participants
Tumour history Adenocarcinoma	121 Participants n=5 Participants
Tumour history Squamous carcinoma	13 Participants n=5 Participants
Tumour history Other	4 Participants n=5 Participants
World Health Organisation (WHO) Performance Status 0	50 Participants n=5 Participants
World Health Organisation (WHO) Performance Status 1	73 Participants n=5 Participants
World Health Organisation (WHO) Performance Status 2	15 Participants n=5 Participants
Disease Stage I	1 Participants n=5 Participants
Disease Stage III A	4 Participants n=5 Participants
Disease Stage III B	20 Participants n=5 Participants
Disease Stage IV	113 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)

Outcome measures

Outcome measures
Measure	Gefitinib n=138 Participants gefitinib tablet 250 mg orally
Objective Response Rate(ORR)	31.2 Percent of participants

SECONDARY outcome

Timeframe: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)

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

Outcome measures

Outcome measures
Measure	Gefitinib n=138 Participants gefitinib tablet 250 mg orally
Period of Progression-Free Survival	5.7 months Interval 3.9 to 8.4

SECONDARY outcome

Timeframe: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)

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.

Outcome measures

Outcome measures
Measure	Gefitinib n=94 Participants gefitinib tablet 250 mg orally
Quality of Life and Symptom Improvement Based on Functional Assessment of Cancer Therapy-Lung (FACT-L)	41 percentage of participants

SECONDARY outcome

Timeframe: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) and every 12 weeks after progression until death or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)

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.

Outcome measures

Outcome measures
Measure	Gefitinib n=154 Participants gefitinib tablet 250 mg orally
Adverse Event	141 participants

Adverse Events

Gefitinib

Serious events: 25 serious events

Other events: 141 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gefitinib n=154 participants at risk gefitinib tablet 250 mg orally
Cardiac disorders Cardiac tamponade	0.65% 1/154 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.
Cardiac disorders Pericardial effusion	0.65% 1/154 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.
Gastrointestinal disorders Diarrhoea	0.65% 1/154 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.
Gastrointestinal disorders Ileus paralytic	0.65% 1/154 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.
Gastrointestinal disorders Asthenia	1.3% 2/154 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.
Gastrointestinal disorders Death	1.9% 3/154 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.
Gastrointestinal disorders Multi-organ failure	0.65% 1/154 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.
Gastrointestinal disorders Sudden death	0.65% 1/154 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.
Infections and infestations Empyema	0.65% 1/154 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.
Infections and infestations Herpes zoster	0.65% 1/154 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.
Infections and infestations Pneumonia	1.9% 3/154 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.
Injury, poisoning and procedural complications Spinal compression fracture	1.3% 2/154 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.
Metabolism and nutrition disorders Hypoglycaemia	0.65% 1/154 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.
Musculoskeletal and connective tissue disorders Back pain	1.3% 2/154 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.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.65% 1/154 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.
Nervous system disorders Cerebral infarction	0.65% 1/154 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.
Psychiatric disorders Depression	0.65% 1/154 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.
Psychiatric disorders Insomnia	0.65% 1/154 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.65% 1/154 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.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.65% 1/154 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.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	1.3% 2/154 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.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.65% 1/154 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.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.65% 1/154 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.
Skin and subcutaneous tissue disorders Rash	0.65% 1/154 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.
Vascular disorders Deep vein thrombosis	0.65% 1/154 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.

Other adverse events

Other adverse events
Measure	Gefitinib n=154 participants at risk gefitinib tablet 250 mg orally
Gastrointestinal disorders Constipation	5.8% 9/154 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.
Gastrointestinal disorders Diarrhoea	26.0% 40/154 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.
Gastrointestinal disorders Vomiting	5.2% 8/154 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.
Gastrointestinal disorders Asthenia	7.8% 12/154 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.
Gastrointestinal disorders Chest pain	6.5% 10/154 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.
Infections and infestations Upper respiratory tract infection	8.4% 13/154 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.
Metabolism and nutrition disorders Anorexia	13.6% 21/154 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.
Musculoskeletal and connective tissue disorders Back pain	5.2% 8/154 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.
Nervous system disorders Dizziness	5.2% 8/154 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.
Nervous system disorders Headache	9.1% 14/154 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.
Respiratory, thoracic and mediastinal disorders Cough	15.6% 24/154 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.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.4% 13/154 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.
Skin and subcutaneous tissue disorders Pruritus	17.5% 27/154 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.
Skin and subcutaneous tissue disorders Rash	33.8% 52/154 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.

Additional Information

Hui Jung Sin

Medical, Astrazeneca Korea

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60