Trial Outcomes & Findings for Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients (NCT NCT01040780)
NCT ID: NCT01040780
Last Updated: 2014-02-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
399 participants
Primary outcome timeframe
2-7 months
Results posted on
2014-02-14
Participant Flow
Patients were enrolled between 26 Febrary 2009 and 13 November 2010 across 27 study sites.
Participant milestones
| Measure |
Icotinib
Icotinib 125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
Gefitinib 250 mg every 24 hours by mouth
|
|---|---|---|
|
Overall Study
STARTED
|
200
|
199
|
|
Overall Study
COMPLETED
|
199
|
196
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Icotinib
Icotinib 125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
Gefitinib 250 mg every 24 hours by mouth
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
3
|
Baseline Characteristics
Safety and Efficacy Study of Icotinb in Non-small Cell Lung Cancer (NSCLC) Patients
Baseline characteristics by cohort
| Measure |
Icotinib
n=200 Participants
Icotinib 125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
n=199 Participants
Gefitinib 250 mg every 24 hours by mouth
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
164 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Age, Continuous
|
55.52 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
56.43 years
STANDARD_DEVIATION 9.43 • n=7 Participants
|
55.98 years
STANDARD_DEVIATION 9.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
118 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
200 participants
n=5 Participants
|
199 participants
n=7 Participants
|
399 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2-7 monthsPopulation: All patients who received at least one dose of study drug with measurable disease at baseline.
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 |
Icotinib
n=199 Participants
125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
n=196 Participants
250 mg every 24 hours by mouth
|
|---|---|---|
|
Progression Free Survival
|
4.6 months
Interval 3.5 to 6.3
|
3.4 months
Interval 2.3 to 3.8
|
SECONDARY outcome
Timeframe: From first study treatment until time of deathMedian number of months from first study treatment until time of death
Outcome measures
| Measure |
Icotinib
n=199 Participants
125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
n=196 Participants
250 mg every 24 hours by mouth
|
|---|---|---|
|
Overall Survival
|
13.3 months
Interval 11.1 to 16.2
|
13.9 months
Interval 11.4 to 17.3
|
SECONDARY outcome
Timeframe: While receiving study treatment; assessed every 21 days until progressionChange in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
Outcome measures
| Measure |
Icotinib
n=199 Participants
125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
n=196 Participants
250 mg every 24 hours by mouth
|
|---|---|---|
|
Best Tumor Response
Disease Control (CR+PR+SD)
|
75.4 percentage of patients
|
74.9 percentage of patients
|
|
Best Tumor Response
Complete Response (CR)
|
0.5 percentage of patients
|
0 percentage of patients
|
|
Best Tumor Response
Partial Response (PR)
|
27.1 percentage of patients
|
27.2 percentage of patients
|
|
Best Tumor Response
Stable Disease (SD)
|
47.7 percentage of patients
|
47.7 percentage of patients
|
|
Best Tumor Response
Progressive Disease (PD)
|
21.1 percentage of patients
|
20.5 percentage of patients
|
SECONDARY outcome
Timeframe: 2-7 monthsMedian time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression.
Outcome measures
| Measure |
Icotinib
n=199 Participants
125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
n=196 Participants
250 mg every 24 hours by mouth
|
|---|---|---|
|
Time To Progression
|
5.2 months
Interval 3.6 to 6.6
|
3.7 months
Interval 2.5 to 5.0
|
SECONDARY outcome
Timeframe: Assessed over two yearsAdverse Events (AEs) and Serious AEs (SAEs) are presented regardless of causality for patients who received at least one dose of Icotinib or Gefitinib. Events were graded by the investigator using the NCI CTCAE Scale (version 3.0) which provides a grading scale for each AE term. Grade 3 = Severe Grade 4 = Life-threatening or disabling
Outcome measures
| Measure |
Icotinib
n=200 Participants
125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
n=199 Participants
250 mg every 24 hours by mouth
|
|---|---|---|
|
Safety and Tolerability
At least one ADR
|
121 participants
|
140 participants
|
|
Safety and Tolerability
At least one SAE
|
13 participants
|
15 participants
|
|
Safety and Tolerability
Grade 3 and 4 AEs
|
9 participants
|
10 participants
|
|
Safety and Tolerability
At least one AE
|
166 participants
|
165 participants
|
Adverse Events
Icotinib
Serious events: 13 serious events
Other events: 166 other events
Deaths: 0 deaths
Gefitinib
Serious events: 15 serious events
Other events: 165 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Icotinib
n=200 participants at risk
Icotinib 125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
n=199 participants at risk
Gefitinib 250 mg every 24 hours by mouth
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
4/200 • Number of events 4
Events were collected by systematic assessment
|
2.5%
5/199 • Number of events 5
Events were collected by systematic assessment
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.50%
1/200 • Number of events 1
Events were collected by systematic assessment
|
1.0%
2/199 • Number of events 2
Events were collected by systematic assessment
|
|
Infections and infestations
Pneumonia
|
0.00%
0/200
Events were collected by systematic assessment
|
1.0%
2/199 • Number of events 2
Events were collected by systematic assessment
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/200 • Number of events 1
Events were collected by systematic assessment
|
0.50%
1/199 • Number of events 1
Events were collected by systematic assessment
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/200
Events were collected by systematic assessment
|
0.50%
1/199 • Number of events 1
Events were collected by systematic assessment
|
|
Cardiac disorders
Cardiac failure
|
1.0%
2/200 • Number of events 2
Events were collected by systematic assessment
|
0.00%
0/199
Events were collected by systematic assessment
|
|
Nervous system disorders
Dizziness
|
0.50%
1/200 • Number of events 1
Events were collected by systematic assessment
|
0.00%
0/199
Events were collected by systematic assessment
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.50%
1/200 • Number of events 1
Events were collected by systematic assessment
|
0.00%
0/199
Events were collected by systematic assessment
|
|
Gastrointestinal disorders
Anorexia
|
0.00%
0/200
Events were collected by systematic assessment
|
0.50%
1/199 • Number of events 1
Events were collected by systematic assessment
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/200
Events were collected by systematic assessment
|
0.50%
1/199 • Number of events 1
Events were collected by systematic assessment
|
|
General disorders
Haemorrhage
|
0.50%
1/200 • Number of events 1
Events were collected by systematic assessment
|
0.00%
0/199
Events were collected by systematic assessment
|
|
Cardiac disorders
Cardio-respiratory failure
|
0.50%
1/200 • Number of events 1
Events were collected by systematic assessment
|
0.00%
0/199
Events were collected by systematic assessment
|
|
General disorders
Multi-organ failure
|
0.50%
1/200 • Number of events 1
Events were collected by systematic assessment
|
1.0%
2/199 • Number of events 2
Events were collected by systematic assessment
|
|
General disorders
Hospitalization due to progression
|
0.50%
1/200 • Number of events 1
Events were collected by systematic assessment
|
0.00%
0/199
Events were collected by systematic assessment
|
Other adverse events
| Measure |
Icotinib
n=200 participants at risk
Icotinib 125 mg three times daily (375 mg per day) by mouth
|
Gefitinib
n=199 participants at risk
Gefitinib 250 mg every 24 hours by mouth
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
40.5%
81/200 • Number of events 81
Events were collected by systematic assessment
|
49.2%
98/199 • Number of events 98
Events were collected by systematic assessment
|
|
Gastrointestinal disorders
Diarrhea
|
21.5%
43/200 • Number of events 43
Events were collected by systematic assessment
|
29.1%
58/199 • Number of events 58
Events were collected by systematic assessment
|
|
General disorders
Pain
|
18.0%
36/200 • Number of events 36
Events were collected by systematic assessment
|
11.1%
22/199 • Number of events 22
Events were collected by systematic assessment
|
|
Investigations
Aminotransferase Increased
|
10.5%
21/200 • Number of events 21
Events were collected by systematic assessment
|
13.1%
26/199 • Number of events 26
Events were collected by systematic assessment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
17/200 • Number of events 17
Events were collected by systematic assessment
|
11.1%
22/199 • Number of events 22
Events were collected by systematic assessment
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.0%
12/200 • Number of events 12
Events were collected by systematic assessment
|
8.0%
16/199 • Number of events 16
Events were collected by systematic assessment
|
|
Gastrointestinal disorders
Anorexia
|
5.5%
11/200 • Number of events 11
Events were collected by systematic assessment
|
7.0%
14/199 • Number of events 14
Events were collected by systematic assessment
|
|
General disorders
Pyrexia
|
3.0%
6/200 • Number of events 6
Events were collected by systematic assessment
|
8.5%
17/199 • Number of events 17
Events were collected by systematic assessment
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.5%
9/200 • Number of events 9
Events were collected by systematic assessment
|
6.0%
12/199 • Number of events 12
Events were collected by systematic assessment
|
|
Gastrointestinal disorders
Nausea
|
4.0%
8/200 • Number of events 8
Events were collected by systematic assessment
|
6.5%
13/199 • Number of events 13
Events were collected by systematic assessment
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
5.0%
10/200 • Number of events 10
Events were collected by systematic assessment
|
5.5%
11/199 • Number of events 11
Events were collected by systematic assessment
|
|
Gastrointestinal disorders
Vomiting
|
4.5%
9/200 • Number of events 9
Events were collected by systematic assessment
|
6.0%
12/199 • Number of events 12
Events were collected by systematic assessment
|
|
Gastrointestinal disorders
Mucositis of oral cavity
|
5.0%
10/200 • Number of events 10
Events were collected by systematic assessment
|
4.5%
9/199 • Number of events 9
Events were collected by systematic assessment
|
Additional Information
Yan Sun, M.D.
Cancer Hospital, Chinese Academy of Medical Sciences
Phone: 0086-010-87788519
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60