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

Study identifier:D7913L00067

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase IV, multicenter, non-randomized, open-labeled study to evaluate the efficacy of Gefitinib (IRESSA®) as a second-line therapy in NSCLC patients

Medical condition

Non Small Cell Lung Carcinoma

Phase

Phase 4

Healthy volunteers

Study drug

Gefitinib

Sex

All

Actual Enrollment

156

Study type

Interventional

Age

19 Years - 80 Years

Date

Study Start Date: 01 Jan 2007

Primary Completion Date: 01 Jan 2009

Study Completion Date: 01 Jan 2009

Study design

Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Daegu, Republic of Korea

Arms	Assigned Interventions

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
Gefitinib	gefitinib tablet 250 mg orally

Participant Flow: Overall Study

	Gefitinib
STARTED	156
Enrolled	156
Safety Population	154^[1]
Treatment Completed	141
Intention to Treat (ITT) population	138^[2]
Per Protocol (PP) population	121
COMPLETED	141
NOT COMPLETED	15
Withdrawal by Subject	7
Protocol Violation	3
Lost to Follow-up	2
Adverse Event	1
Physician Decision	2

[1]	2 patients who received no study treatment were excluded
[2]	8 patients who had no target lesion and 8 who had no tumor assessment after baseline were excluded

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

Reporting Groups

	Description
Gefitinib	gefitinib tablet 250 mg orally

Baseline Measures

	Gefitinib
Number of Participants [units: Participants]	138
AgeCategoricalOther [units: participants]
< 65 years	72
>= 65 years	66
Gender, Male/Female [units: Participants]
Female	120
Male	18
Other ^[1] [units: Participants]
Positive	59
Negative	50
Unknown	29
Other [units: Participants]
Never-smoker	117
Ex-smoker	17
Regular smoker	4
Other [units: Participants]
Adenocarcinoma	121
Squamous carcinoma	13
Other	4
Other ^[2] [units: Participants]
0	50
1	73
2	15
Disease Stage ^[3] [units: Participants]
I	1
III A	4
III B	20
IV	113

Outcome Measures

1. Primary Outcome Measure: Objective Response Rate(ORR) [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]

Measure Type	Primary
Measure Name	Objective Response Rate(ORR)
Measure Description	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.
Time Frame	Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Gefitinib	gefitinib tablet 250 mg orally

Measured Values

	Gefitinib
Number of Participants Analyzed [units:participants]	138
Objective Response Rate(ORR) [units: Percent of participants]	31.2

No statistical analysis provided for Objective Response Rate(ORR)

2. Secondary Outcome Measure: Period of Progression-Free Survival [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]

Measure Type	Secondary
Measure Name	Period of Progression-Free Survival
Measure Description	The median months without event of progression disease according to RECIST criteria is analysed.
Time Frame	Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Gefitinib	gefitinib tablet 250 mg orally

Measured Values

	Gefitinib
Number of Participants Analyzed [units:participants]	138
Period of Progression-Free Survival [units: months] Median (95% Confidence Interval)	5.7 (3.9 to 8.4)

No statistical analysis provided for Period of Progression-Free Survival

3. Secondary Outcome Measure: Quality of life and symptom improvement based on Functional Assessment of Cancer Therapy-Lung (FACT-L) [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]

Measure Type	Secondary
Measure Name	Quality of life and symptom improvement based on Functional Assessment of Cancer Therapy-Lung (FACT-L)
Measure Description	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.
Time Frame	Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
Safety Issue?	No

Population Description

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.

Reporting Groups

	Description
Gefitinib	gefitinib tablet 250 mg orally

Measured Values

	Gefitinib
Number of Participants Analyzed [units:participants]	94
Quality of life and symptom improvement based on Functional Assessment of Cancer Therapy-Lung (FACT-L) [units: percentage of participants]	41

No statistical analysis provided for Quality of life and symptom improvement based on Functional Assessment of Cancer Therapy-Lung (FACT-L)

4. Secondary Outcome Measure: Overall Survival [ Time Frame: 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. ]

Measure Type	Secondary
Measure Name	Overall Survival
Measure Description
Time Frame	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.
Safety Issue?	No

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary Outcome Measure: Adverse event [ Time Frame: Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009) ]

Measure Type	Secondary
Measure Name	Adverse event
Measure Description	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.
Time Frame	Every 8 weeks until progression disease or death or Data Cut off date (2 January 2009)
Safety Issue?	Yes

Population Description

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.

Reporting Groups

	Description
Gefitinib	gefitinib tablet 250 mg orally

Measured Values

	Gefitinib
Number of Participants Analyzed [units:participants]	154
Adverse event [units: participants]	141

No statistical analysis provided for Adverse event

Serious Adverse Events

Time Frame	No text entered.
Additional Description	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.

Reporting Groups

	Description
Gefitinib	gefitinib tablet 250 mg orally

Serious Adverse Events

Gefitinib

Total, serious adverse events

# participants affected / at risk

25/154 (16.23%)

Cardiac disorders

Cardiac tamponade¹,^†

# participants affected / at risk

1/154 (0.65%)

Cardiac disorders

Pericardial effusion¹,^†

# participants affected / at risk

1/154 (0.65%)

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

1/154 (0.65%)

Gastrointestinal disorders

Ileus paralytic¹,^†

# participants affected / at risk

1/154 (0.65%)

Gastrointestinal disorders

Asthenia¹,^†

# participants affected / at risk

2/154 (1.30%)

Gastrointestinal disorders

Death¹,^†

# participants affected / at risk

3/154 (1.95%)

Gastrointestinal disorders

Multi-organ failure¹,^†

# participants affected / at risk

1/154 (0.65%)

Gastrointestinal disorders

Sudden death¹,^†

# participants affected / at risk

1/154 (0.65%)

Infections and infestations

Empyema¹,^†

# participants affected / at risk

1/154 (0.65%)

Infections and infestations

Herpes zoster¹,^†

# participants affected / at risk

1/154 (0.65%)

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

3/154 (1.95%)

Injury, poisoning and procedural complications

Spinal compression fracture¹,^†

# participants affected / at risk

2/154 (1.30%)

Metabolism and nutrition disorders

Hypoglycaemia¹,^†

# participants affected / at risk

1/154 (0.65%)

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

2/154 (1.30%)

Musculoskeletal and connective tissue disorders

Spinal osteoarthritis¹,^†

# participants affected / at risk

1/154 (0.65%)

Nervous system disorders

Cerebral infarction¹,^†

# participants affected / at risk

1/154 (0.65%)

Psychiatric disorders

Depression¹,^†

# participants affected / at risk

1/154 (0.65%)

Psychiatric disorders

Insomnia¹,^†

# participants affected / at risk

1/154 (0.65%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

1/154 (0.65%)

Respiratory, thoracic and mediastinal disorders

Haemoptysis¹,^†

# participants affected / at risk

1/154 (0.65%)

Respiratory, thoracic and mediastinal disorders

Interstitial lung disease¹,^†

# participants affected / at risk

2/154 (1.30%)

Respiratory, thoracic and mediastinal disorders

Pulmonary embolism¹,^†

# participants affected / at risk

1/154 (0.65%)

Respiratory, thoracic and mediastinal disorders

Pulmonary oedema¹,^†

# participants affected / at risk

1/154 (0.65%)

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

1/154 (0.65%)

Vascular disorders

Deep vein thrombosis¹,^†

# participants affected / at risk

1/154 (0.65%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary,

Other Adverse Events

Time Frame	No text entered.
Additional Description	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.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
Gefitinib	gefitinib tablet 250 mg orally

Other Adverse Events

Gefitinib

Total, other (not including serious) adverse events

# participants affected / at risk

141/154 (91.56%)

Gastrointestinal disorders

Constipation¹,^†

# participants affected / at risk

9/154 (5.84%)

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

40/154 (25.97%)

Gastrointestinal disorders

Vomiting¹,^†

# participants affected / at risk

8/154 (5.19%)

Gastrointestinal disorders

Asthenia¹,^†

# participants affected / at risk

12/154 (7.79%)

Gastrointestinal disorders

Chest pain¹,^†

# participants affected / at risk

10/154 (6.49%)

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

13/154 (8.44%)

Metabolism and nutrition disorders

Anorexia¹,^†

# participants affected / at risk

21/154 (13.64%)

Musculoskeletal and connective tissue disorders

Back pain¹,^†

# participants affected / at risk

8/154 (5.19%)

Nervous system disorders

Dizziness¹,^†

# participants affected / at risk

8/154 (5.19%)

Nervous system disorders

Headache¹,^†

# participants affected / at risk

14/154 (9.09%)

Respiratory, thoracic and mediastinal disorders

Cough¹,^†

# participants affected / at risk

24/154 (15.58%)

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

13/154 (8.44%)

Skin and subcutaneous tissue disorders

Pruritus¹,^†

# participants affected / at risk

27/154 (17.53%)

Skin and subcutaneous tissue disorders

Rash¹,^†

# participants affected / at risk

52/154 (33.77%)

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary,

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description:

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Hui Jung Sin
Organization:	Medical, Astrazeneca Korea
E-mail:	[email protected]

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=411&filename=CSR-D7913L00067.pdf
Download
CSR-D7913L00067.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Korea

82 2 2188 0800

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

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

CSR-D7913L00067.pdf

Trial Results Summaries