Trial Outcomes & Findings for Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery (NCT NCT00049543)
NCT ID: NCT00049543
Last Updated: 2015-01-01
Results Overview
The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the overall survival between two arms adjusting for the stratification factors. An unadjusted analysis will also be performed. Five years survival rate will be reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
503 participants
Primary outcome timeframe
From randomization to the time of death from any cause, assessed up to 5 years
Results posted on
2015-01-01
Participant Flow
Participant milestones
| Measure |
Arm I (Gefitinib)
Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
251
|
252
|
|
Overall Study
COMPLETED
|
249
|
243
|
|
Overall Study
NOT COMPLETED
|
2
|
9
|
Reasons for withdrawal
| Measure |
Arm I (Gefitinib)
Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
still on treatment
|
2
|
9
|
Baseline Characteristics
Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery
Baseline characteristics by cohort
| Measure |
Arm I (Gefitinib)
n=251 Participants
Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=252 Participants
Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Total
n=503 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
|
105 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
146 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
278 Participants
n=5 Participants
|
|
Age, Continuous
|
67.3 years
n=5 Participants
|
65.9 years
n=7 Participants
|
66.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
135 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
271 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
233 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
468 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
52 participants
n=5 Participants
|
50 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
199 participants
n=5 Participants
|
202 participants
n=7 Participants
|
401 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the time of death from any cause, assessed up to 5 yearsPopulation: ITT population
The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the overall survival between two arms adjusting for the stratification factors. An unadjusted analysis will also be performed. Five years survival rate will be reported.
Outcome measures
| Measure |
Arm I (Gefitinib)
n=251 Participants
Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=252 Participants
Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Survival
|
0.52 percentage of 5 years survival rate
Interval 0.44 to 0.58
|
0.57 percentage of 5 years survival rate
Interval 0.51 to 0.64
|
SECONDARY outcome
Timeframe: From randomization to the time of documented recurrence of the primary cancer, assessed up to 5 yearsPopulation: ITT population
The survival experience of patients in both treatment groups will be described by the Kaplan-Meier method. A stratified log-rank test will be used as the primary method to compare the disease free survival between two arms adjusting for the stratification factors. Five years disease free survival rate will be reported.
Outcome measures
| Measure |
Arm I (Gefitinib)
n=251 Participants
Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=252 Participants
Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Disease Free Survival
|
0.49 percentage of 5-year disease free rate
Interval 0.42 to 0.55
|
0.56 percentage of 5-year disease free rate
Interval 0.5 to 0.63
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: All patients who received at least 1 dose of the treatment
The incidence of toxicities will be summarized by type of adverse event and severity. A Fisher's exact test will be used to compare toxicities between the two arms.
Outcome measures
| Measure |
Arm I (Gefitinib)
n=249 Participants
Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=243 Participants
Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Incidence of Toxicities Graded Using the NCI Common Terminology Criteria for Adverse Events Version 3.0
|
229 participants
|
153 participants
|
Adverse Events
Arm I (Gefitinib)
Serious events: 34 serious events
Other events: 240 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 43 serious events
Other events: 226 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Gefitinib)
n=249 participants at risk
Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=243 participants at risk
Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Cardiac disorders
Cardiac General - Other
|
0.80%
2/249
|
1.6%
4/243
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.40%
1/249
|
0.41%
1/243
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.40%
1/249
|
0.00%
0/243
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.40%
1/249
|
0.00%
0/243
|
|
Eye disorders
Blurred vision
|
0.40%
1/249
|
0.00%
0/243
|
|
Eye disorders
Ocular - Other
|
0.40%
1/249
|
0.00%
0/243
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
4/249
|
0.82%
2/243
|
|
Gastrointestinal disorders
Dry mouth
|
0.40%
1/249
|
0.00%
0/243
|
|
Gastrointestinal disorders
Esophagitis
|
0.40%
1/249
|
0.00%
0/243
|
|
Gastrointestinal disorders
Fistula, GI Small bowel NOS
|
0.00%
0/249
|
0.41%
1/243
|
|
Gastrointestinal disorders
GI - Other
|
0.40%
1/249
|
0.41%
1/243
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/249
|
0.41%
1/243
|
|
Gastrointestinal disorders
Heartburn
|
0.40%
1/249
|
0.41%
1/243
|
|
Gastrointestinal disorders
Hemorrhage, GI Colon
|
0.40%
1/249
|
0.00%
0/243
|
|
Gastrointestinal disorders
Hemorrhage, GI Lower GI NOS
|
0.40%
1/249
|
0.00%
0/243
|
|
Gastrointestinal disorders
Hemorrhage, GI Upper GI NOS
|
0.40%
1/249
|
0.00%
0/243
|
|
Gastrointestinal disorders
Nausea
|
0.80%
2/249
|
0.41%
1/243
|
|
Gastrointestinal disorders
Pain Abdomen NOS
|
0.40%
1/249
|
0.41%
1/243
|
|
Gastrointestinal disorders
Pancreatitis
|
0.80%
2/249
|
0.41%
1/243
|
|
Gastrointestinal disorders
Vomiting
|
0.80%
2/249
|
0.00%
0/243
|
|
General disorders
Constitutional Symptoms - Other
|
0.00%
0/249
|
0.82%
2/243
|
|
General disorders
Death Disease progression NOS
|
0.40%
1/249
|
0.00%
0/243
|
|
General disorders
Edema: limb
|
0.00%
0/249
|
0.82%
2/243
|
|
General disorders
Fatigue
|
0.80%
2/249
|
0.41%
1/243
|
|
General disorders
Fever
|
0.80%
2/249
|
0.41%
1/243
|
|
General disorders
Pain - Other
|
0.40%
1/249
|
0.00%
0/243
|
|
General disorders
Pain Chest/thorax NOS
|
0.00%
0/249
|
1.6%
4/243
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/249
|
0.41%
1/243
|
|
Hepatobiliary disorders
Liver dysfunction
|
0.80%
2/249
|
0.00%
0/243
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/249
|
0.41%
1/243
|
|
Infections and infestations
Infection - Other
|
1.6%
4/249
|
1.2%
3/243
|
|
Infections and infestations
Infection with normal ANC Lung
|
0.40%
1/249
|
0.41%
1/243
|
|
Infections and infestations
Infection with unknown ANC Lung
|
0.00%
0/249
|
0.82%
2/243
|
|
Injury, poisoning and procedural complications
Fracture
|
0.80%
2/249
|
0.00%
0/243
|
|
Investigations
ALT
|
0.00%
0/249
|
0.41%
1/243
|
|
Investigations
AST
|
0.00%
0/249
|
0.41%
1/243
|
|
Investigations
Creatinine
|
0.00%
0/249
|
0.41%
1/243
|
|
Investigations
Weight gain
|
0.40%
1/249
|
0.00%
0/243
|
|
Investigations
Weight loss
|
0.40%
1/249
|
0.00%
0/243
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/249
|
0.41%
1/243
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
3/249
|
0.82%
2/243
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/249
|
0.41%
1/243
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/249
|
0.41%
1/243
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/249
|
0.41%
1/243
|
|
Musculoskeletal and connective tissue disorders
Pain Bone
|
0.00%
0/249
|
0.41%
1/243
|
|
Musculoskeletal and connective tissue disorders
Pain Extremity-limb
|
0.00%
0/249
|
0.41%
1/243
|
|
Musculoskeletal and connective tissue disorders
Pain Joint
|
0.40%
1/249
|
0.41%
1/243
|
|
Nervous system disorders
Ataxia
|
0.40%
1/249
|
0.00%
0/243
|
|
Nervous system disorders
CNS hemorrhage
|
0.40%
1/249
|
0.00%
0/243
|
|
Nervous system disorders
Dizziness
|
0.40%
1/249
|
0.41%
1/243
|
|
Nervous system disorders
Encephalopathy
|
0.40%
1/249
|
0.00%
0/243
|
|
Nervous system disorders
Neuropathy-sensory
|
0.40%
1/249
|
0.41%
1/243
|
|
Nervous system disorders
Pain Head/headache
|
0.00%
0/249
|
0.41%
1/243
|
|
Nervous system disorders
Seizure
|
0.40%
1/249
|
0.00%
0/243
|
|
Nervous system disorders
Speech impairment
|
0.00%
0/249
|
0.41%
1/243
|
|
Nervous system disorders
Syncope
|
0.00%
0/249
|
0.41%
1/243
|
|
Psychiatric disorders
Confusion
|
0.00%
0/249
|
0.82%
2/243
|
|
Psychiatric disorders
Mood alteration Anxiety
|
0.80%
2/249
|
0.82%
2/243
|
|
Psychiatric disorders
Mood alteration Depression
|
0.00%
0/249
|
0.41%
1/243
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/249
|
0.41%
1/243
|
|
Renal and urinary disorders
Renal - Other
|
0.40%
1/249
|
0.41%
1/243
|
|
Renal and urinary disorders
Renal failure
|
0.40%
1/249
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
0.40%
1/249
|
0.00%
0/243
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/249
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.80%
2/249
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.0%
10/249
|
5.8%
14/243
|
|
Respiratory, thoracic and mediastinal disorders
Fistula, pulmonary Lung
|
0.00%
0/249
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary Lung
|
0.40%
1/249
|
0.00%
0/243
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary Respiratory tract NOS
|
0.00%
0/249
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.40%
1/249
|
0.00%
0/243
|
|
Respiratory, thoracic and mediastinal disorders
Pain Pleura
|
0.00%
0/249
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.40%
1/249
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.6%
4/249
|
1.2%
3/243
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.40%
1/249
|
0.00%
0/243
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary - Other
|
0.80%
2/249
|
0.41%
1/243
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/249
|
0.41%
1/243
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.40%
1/249
|
0.00%
0/243
|
|
Skin and subcutaneous tissue disorders
Hand-foot
|
0.40%
1/249
|
0.00%
0/243
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/249
|
0.82%
2/243
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.40%
1/249
|
0.00%
0/243
|
|
Vascular disorders
Hypertension
|
0.00%
0/249
|
0.41%
1/243
|
|
Vascular disorders
Hypotension
|
0.40%
1/249
|
0.41%
1/243
|
|
Vascular disorders
Peripheral arterial ischemia
|
0.00%
0/249
|
0.41%
1/243
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.6%
4/249
|
0.41%
1/243
|
Other adverse events
| Measure |
Arm I (Gefitinib)
n=249 participants at risk
Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
gefitinib: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=243 participants at risk
Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
15.7%
39/249
|
13.6%
33/243
|
|
Gastrointestinal disorders
Diarrhea
|
62.2%
155/249
|
30.9%
75/243
|
|
Gastrointestinal disorders
Heartburn
|
7.6%
19/249
|
8.2%
20/243
|
|
Gastrointestinal disorders
Nausea
|
26.5%
66/249
|
18.5%
45/243
|
|
Gastrointestinal disorders
Pain Abdomen NOS
|
7.2%
18/249
|
2.9%
7/243
|
|
Gastrointestinal disorders
Vomiting
|
12.9%
32/249
|
7.8%
19/243
|
|
General disorders
Edema: limb
|
4.4%
11/249
|
5.8%
14/243
|
|
General disorders
Fatigue
|
54.2%
135/249
|
53.5%
130/243
|
|
General disorders
Pain Chest/thorax NOS
|
34.5%
86/249
|
44.0%
107/243
|
|
Infections and infestations
Infection - Other
|
7.6%
19/249
|
8.2%
20/243
|
|
Investigations
ALT
|
5.2%
13/249
|
1.2%
3/243
|
|
Investigations
AST
|
5.6%
14/249
|
0.82%
2/243
|
|
Investigations
Weight loss
|
6.4%
16/249
|
2.5%
6/243
|
|
Metabolism and nutrition disorders
Anorexia
|
28.1%
70/249
|
16.5%
40/243
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.4%
26/249
|
9.5%
23/243
|
|
Musculoskeletal and connective tissue disorders
Pain Back
|
5.2%
13/249
|
7.0%
17/243
|
|
Musculoskeletal and connective tissue disorders
Pain Bone
|
4.4%
11/249
|
6.2%
15/243
|
|
Musculoskeletal and connective tissue disorders
Pain Joint
|
5.6%
14/249
|
9.5%
23/243
|
|
Musculoskeletal and connective tissue disorders
Pain Muscle
|
4.8%
12/249
|
9.5%
23/243
|
|
Nervous system disorders
Dizziness
|
6.8%
17/249
|
7.0%
17/243
|
|
Nervous system disorders
Neuropathy-sensory
|
10.4%
26/249
|
15.6%
38/243
|
|
Nervous system disorders
Pain Head/headache
|
7.6%
19/249
|
6.2%
15/243
|
|
Psychiatric disorders
Insomnia
|
4.8%
12/249
|
7.8%
19/243
|
|
Psychiatric disorders
Mood alteration Anxiety
|
6.4%
16/249
|
4.5%
11/243
|
|
Psychiatric disorders
Mood alteration Depression
|
5.6%
14/249
|
5.8%
14/243
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.3%
63/249
|
29.2%
71/243
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
52.2%
130/249
|
60.5%
147/243
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary Nose
|
6.4%
16/249
|
1.6%
4/243
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.2%
13/249
|
0.41%
1/243
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.8%
22/249
|
5.8%
14/243
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
43.0%
107/249
|
18.9%
46/243
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
5.2%
13/249
|
1.6%
4/243
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
36.9%
92/249
|
13.2%
32/243
|
|
Skin and subcutaneous tissue disorders
Rash
|
67.1%
167/249
|
27.2%
66/243
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60