Trial Outcomes & Findings for Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC) (NCT NCT00770588)
NCT ID: NCT00770588
Last Updated: 2016-02-08
Results Overview
PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
COMPLETED
PHASE4
296 participants
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.
2016-02-08
Participant Flow
A total of 298 patients were screened for the study and 296 subsequently randomized
Participant milestones
| Measure |
Gefitinib
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
placebo 1 tablet daily
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
148
|
|
Overall Study
COMPLETED
|
67
|
53
|
|
Overall Study
NOT COMPLETED
|
81
|
95
|
Reasons for withdrawal
| Measure |
Gefitinib
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
placebo 1 tablet daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
2
|
|
Overall Study
Death caused by progression of disease
|
70
|
91
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Assess the Efficacy, Safety and Tolerability of Gefitinib (Iressa® 250mg) as Maintenance Therapy in Locally Advanced or Metastatic (Stage IIIB/IV) Non Small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Gefitinib
n=148 Participants
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
n=148 Participants
placebo 1 tablet daily
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<45 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
107 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Age, Customized
65-74 years
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Smoking status
non-smoker
|
79 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Smoking status
ex-smoker
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Smoking status
current smoker
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.The primary analysis of PFS will be performed when at least 265 events have occurred, which is expected to occur approximately.PFS will be calculated from the tumour measurements collected at each tumour assessment per the RECIST criteria and/or the date of patient death. Progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline.
Outcome measures
| Measure |
Gefitinib
n=148 Participants
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
n=148 Participants
placebo 1 tablet daily
|
|---|---|---|
|
Progression Free Survival (PFS)
|
4.8 month
Interval 3.19 to 8.54
|
2.6 month
Interval 1.61 to 2.76
|
SECONDARY outcome
Timeframe: The OS will be assessed from the time of randomization to death from any cause.For patients not known to have died or who have withdrawn from the study for whatever reason,OS will be censored at the last date at which patients were known to be alive.The OS will be assessed from the time of randomisation to death from any cause. For patients not known to have died(which may include those who have been lost to follow up or who have withdrawn from the study for whatever reason), OS will be censored for the analysis at the last date at which the patients were known to be alive.
Outcome measures
| Measure |
Gefitinib
n=148 Participants
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
n=148 Participants
placebo 1 tablet daily
|
|---|---|---|
|
Overall Survival (OS)
|
18.7 month
Interval 15.6 to 22.2
|
16.9 month
Interval 14.5 to 19.0
|
SECONDARY outcome
Timeframe: TTumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.The objective tumour response will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Gefitinib
n=148 Participants
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
n=148 Participants
placebo 1 tablet daily
|
|---|---|---|
|
Objective Tumour Response (ORR)
|
35 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause.DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at randomization, every 6 weeks until disease progression, and at discontinuation.Symptom improvement will be assessed from the 7-question Lung Cancer Subscale domain score derived from the FACT-L questionnaire. It is defined as an increase of two or more points on the LCS from randomization, maintained for 21 or more days. It will be calculated as the number of patients analysed with improvement.
Outcome measures
| Measure |
Gefitinib
n=148 Participants
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
n=148 Participants
placebo 1 tablet daily
|
|---|---|---|
|
Symptom Improvement
|
34 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug. Any ongoing AE or SAE at discontinuation of study treatment and during 28 day follow-up period must be monitoredAppropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse events will be calculated.
Outcome measures
| Measure |
Gefitinib
n=147 Participants
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
n=148 Participants
placebo 1 tablet daily
|
|---|---|---|
|
Adverse Event
|
118 Participants
|
79 Participants
|
Adverse Events
Gefitinib
Placebo
Serious adverse events
| Measure |
Gefitinib
n=147 participants at risk
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
n=148 participants at risk
placebo 1 tablet daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
1.4%
2/147
|
0.00%
0/148
|
|
Infections and infestations
Lung Infection
|
1.4%
2/147
|
0.00%
0/148
|
|
Infections and infestations
Pneumonia
|
1.4%
2/147
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.68%
1/147
|
0.00%
0/148
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/147
|
0.68%
1/148
|
|
General disorders
Death
|
0.68%
1/147
|
0.00%
0/148
|
|
General disorders
Sudden Death
|
0.68%
1/147
|
0.00%
0/148
|
|
General disorders
Accidental Death
|
0.00%
0/147
|
0.68%
1/148
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/147
|
0.68%
1/148
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/147
|
0.68%
1/148
|
|
Nervous system disorders
Paraplegia
|
0.68%
1/147
|
0.00%
0/148
|
|
Psychiatric disorders
Completed Suicide
|
0.00%
0/147
|
0.68%
1/148
|
|
Skin and subcutaneous tissue disorders
Subcutaneous Nodule
|
0.00%
0/147
|
0.68%
1/148
|
|
Vascular disorders
Arterial Thrombosis Limb
|
0.68%
1/147
|
0.00%
0/148
|
|
Vascular disorders
Circulatory Collapse
|
0.68%
1/147
|
0.00%
0/148
|
Other adverse events
| Measure |
Gefitinib
n=147 participants at risk
Gefitinib (Iressa® 250 mg) 1 tablet daily
|
Placebo
n=148 participants at risk
placebo 1 tablet daily
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
49.7%
73/147
|
9.5%
14/148
|
|
Skin and subcutaneous tissue disorders
pruritus
|
6.8%
10/147
|
4.7%
7/148
|
|
Skin and subcutaneous tissue disorders
dry skin
|
6.1%
9/147
|
2.0%
3/148
|
|
Skin and subcutaneous tissue disorders
skin exfoliation
|
6.1%
9/147
|
0.00%
0/148
|
|
Gastrointestinal disorders
diarrhoea
|
25.2%
37/147
|
8.8%
13/148
|
|
Investigations
Alanine Aminotransferase Increased
|
21.1%
31/147
|
8.1%
12/148
|
|
Investigations
aspartate aminotransferase increased
|
14.3%
21/147
|
4.1%
6/148
|
|
Investigations
transaminases increased
|
5.4%
8/147
|
1.4%
2/148
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
6.1%
9/147
|
13.5%
20/148
|
|
Investigations
serious hepatic dysfunction
|
29.3%
43/147
|
10.8%
16/148
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI agrees to collaborate in good faith with AZ regard to contents and formation of any publication and to pay due consideration to the comments, views and opinions offered by AZ. AZ shall have a period of 30 days from receipt of the proposed final manuscript to review and may require submission be delayed in order for AZ to file patent application
- Publication restrictions are in place
Restriction type: OTHER