Trial Outcomes & Findings for Icotinib for Completed Resected IB NSCLC With EGFR Mutation (NCT NCT02264210)
NCT ID: NCT02264210
Last Updated: 2024-09-25
Results Overview
3-year DFS was defined as the percentage of patients who were disease free at 3 years. 3-year DFS were calculated by the Kaplan-Meier method, and the difference in 3-year DFS between groups was compared by the Z test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
128 participants
Primary outcome timeframe
From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years
Results posted on
2024-09-25
Participant Flow
Participant milestones
| Measure |
Intervention Group
Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.
Icotinib: Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.
|
Observation Group
Observation.
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
65
|
|
Overall Study
COMPLETED
|
63
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Icotinib for Completed Resected IB NSCLC With EGFR Mutation
Baseline characteristics by cohort
| Measure |
Intervention Group
n=63 Participants
Icotinib: Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.
|
Observation Group
n=65 Participants
Observation only group.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 Years
n=5 Participants
|
57 Years
n=7 Participants
|
56 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
63 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
EGFR mutation site
Exon 19 deletion
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
EGFR mutation site
Exon 21 L858R
|
29 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
EGFR mutation site
Exon 18 G719X
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the time of disease recurrence or death as a result of any cause, assessed up to 3 years3-year DFS was defined as the percentage of patients who were disease free at 3 years. 3-year DFS were calculated by the Kaplan-Meier method, and the difference in 3-year DFS between groups was compared by the Z test.
Outcome measures
| Measure |
Intervention Group
n=63 Participants
Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.
|
Observation Group
n=65 Participants
Observation alone group.
|
|---|---|---|
|
3-year Disease-Free Survival
|
96.1 Percentage of patients at 3 years
Interval 91.3 to 99.9
|
84.0 Percentage of patients at 3 years
Interval 75.1 to 92.9
|
Adverse Events
Intervention Group
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Observation Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Intervention Group
n=63 participants at risk
Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.
|
Observation Group
n=65 participants at risk
Observation alone group.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
3.2%
2/63 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
0.00%
0/65 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
1/63 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
0.00%
0/65 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
|
General disorders
Pain
|
1.6%
1/63 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
0.00%
0/65 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
Other adverse events
| Measure |
Intervention Group
n=63 participants at risk
Icotinib 125 mg three times daily (375 mg per day) orally for 12 months.
|
Observation Group
n=65 participants at risk
Observation alone group.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
39.7%
25/63 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
0.00%
0/65 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.6%
13/63 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
0.00%
0/65 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
|
General disorders
Pain
|
11.1%
7/63 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
0.00%
0/65 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
|
Blood and lymphatic system disorders
Elevated ALT
|
9.5%
6/63 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
0.00%
0/65 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
|
General disorders
Decreased appetite
|
7.9%
5/63 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
0.00%
0/65 • 1 year
All AEs were classified according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place