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Trial record 1 of 1 for:    NCT01774721
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ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC. (ARCHER1050)

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ClinicalTrials.gov Identifier: NCT01774721
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Results First Posted : October 26, 2018
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Pfizer
SFJ Lung Cancer Ltd.
Information provided by (Responsible Party):
SFJ Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer With EGFR-Activating Mutations
Interventions Drug: Dacomitinib (PF-00299804)
Drug: Gefitinib
Enrollment 452
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description Participants received 45 milligrams (mg) of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first. Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Period Title: Overall Study
Started 227 225
Treated 227 224
Completed 0 0
Not Completed 227 225
Reason Not Completed
Death             76             91
Withdrawal by Subject             14             10
Lost to Follow-up             1             1
Did not meet eligibility criteria             0             3
Ongoing in study             136             120
Arm/Group Title Dacomitinib Gefitinib Total
Hide Arm/Group Description Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first. Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first. Total of all reporting groups
Overall Number of Baseline Participants 227 225 452
Hide Baseline Analysis Population Description
ITT Population included all participants who were randomized, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or received a different treatment from that to which they were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 227 participants 225 participants 452 participants
61.2  (11.26) 60.9  (10.17) 61.1  (10.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 227 participants 225 participants 452 participants
Female
146
  64.3%
125
  55.6%
271
  60.0%
Male
81
  35.7%
100
  44.4%
181
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 227 participants 225 participants 452 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
227
 100.0%
225
 100.0%
452
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 227 participants 225 participants 452 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
170
  74.9%
176
  78.2%
346
  76.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   0.4%
0
   0.0%
1
   0.2%
White
56
  24.7%
49
  21.8%
105
  23.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression Free Survival (PFS) Based on Independent Radiologic Central (IRC) Review
Hide Description PFS: time from randomization to date of progression of disease (PD) as determined by IRC review as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD for target lesions: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm; for non-target lesions: unequivocal progression of pre-existing lesions. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.
Time Frame Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 225
Median (95% Confidence Interval)
Unit of Measure: months
14.7
(11.1 to 16.6)
9.2
(9.1 to 11.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dacomitinib, Gefitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method 1-sided stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.589
Confidence Interval (2-Sided) 95%
0.469 to 0.739
Estimation Comments Based on stratified Cox regression model
2.Secondary Outcome
Title Progression Free Survival (PFS) Based on Investigator Assessment
Hide Description PFS: time from randomization to date of PD as determined by investigator assessment as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria or death due to any cause, whichever occurred first. PD for target lesions: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm; for non-target lesions: unequivocal progression of pre-existing lesions. Overall tumor burden increased sufficiently to merit discontinuation of therapy. In presence of stable disease (did not achieve partial response, complete response or PD) or partial response (>=30% decrease under baseline of sum of diameters of all target measurable lesions, short diameter used in the sum for target nodes, longest diameter used in sum for all other target lesions) in target disease; for new lesions: appearance of any new unequivocal malignant lesion indicated PD.
Time Frame Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 225
Median (95% Confidence Interval)
Unit of Measure: months
16.6
(12.9 to 18.4)
11.0
(9.4 to 12.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dacomitinib, Gefitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method 1-sided stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.622
Confidence Interval (2-Sided) 95%
0.497 to 0.779
Estimation Comments Based on stratified Cox regression model
3.Secondary Outcome
Title Number of Participants With Best Overall Response (BOR) Based on IRC Review
Hide Description Number of participants with BOR based on IRC review(complete response[CR] or confirmed partial response[PR]) was recorded from randomization until disease progression based on RECISTv1.1. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes must decreased to normal size(short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be ‘normal’ in size(<short axis <10 mm); for new lesions: repeated assessments of a new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter was used in sum for target nodes, longest diameter was used in sum for all other target lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Time Frame Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 225
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
12
   5.3%
4
   1.8%
Partial response
158
  69.6%
157
  69.8%
4.Secondary Outcome
Title Number of Participants With Best Overall Response (BOR) Based on Investigator Assessment
Hide Description Number of participants with BOR based on investigator assessment (CR or confirmed PR) was recorded from randomization until disease progression based on RECIST v1.1. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes must decreased to normal size (short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be ‘normal’ in size (<short axis <10 mm); for new lesions: repeated assessments of a new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter was used in sum for target nodes, longest diameter was used in sum for all other target lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Time Frame Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 225
Measure Type: Count of Participants
Unit of Measure: Participants
Complete response
2
   0.9%
1
   0.4%
Partial response
169
  74.4%
157
  69.8%
5.Secondary Outcome
Title Objective Response Rate (ORR) Based on IRC Review
Hide Description Percentage of participants with a BOR of either CR or PR based on IRC review recorded from the start of treatment until disease progression based on RECIST v1.1. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes must decreased to normal size (short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be ‘normal’ in size (<short axis <10 mm); for new lesions: repeated assessments of a new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter was used in sum for target nodes, longest diameter was used in sum for all other target lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Time Frame Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
74.9
(68.7 to 80.4)
71.6
(65.2 to 77.4)
6.Secondary Outcome
Title Objective Response Rate (ORR) Based on Investigator Assessment
Hide Description Percentage of participants with a BOR of either CR or PR based on investigator assessment recorded from the start of treatment until disease progression based on RECIST v1.1. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes must decreased to normal size (short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be ‘normal’ in size (<short axis <10 mm); for new lesions: repeated assessments of a new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter was used in sum for target nodes, longest diameter was used in sum for all other target lesions. PD was defined as 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Time Frame Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 225
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.3
(69.2 to 80.8)
70.2
(63.8 to 76.1)
7.Secondary Outcome
Title Duration of Response (DoR)
Hide Description DoR was defined as time from first documentation of objective response(CR or PR, whichever occurred first)to date of PD or death from any cause, whichever occurred first. CR for target lesion: disappearance of all target lesions with exception of nodal disease. All target nodes decreased to normal size(short axis <10 mm); for non-target lesions: disappearance of all non-target lesions and normalization of tumor marker levels. All lymph nodes must be ‘normal’ in size(<short axis <10 mm); for new lesions:repeated assessments of new lesion if it was equivocal. PR: >=30% decrease under baseline of sum of all target measurable lesions, short diameter used in sum for target nodes, longest diameter used in sum for all other target lesions. PD: 20% increase in sum of diameters of target measurable lesions above the smallest sum observed(over baseline if no decrease in sum is observed),with a minimum absolute increase of 5 mm. DoR was recorded based on IRC review and investigator’s assessment.
Time Frame Day 28 of Cycle 1, Cycle 2 then every 8 weeks until disease progression or death due to any cause, whichever occurred first (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population included all randomized participants, with study treatment assignment designated according to initial randomization, regardless of whether participants received study treatment or a different treatment from that to which they were randomized.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 225
Median (95% Confidence Interval)
Unit of Measure: months
DoR: IRC review Number Analyzed 170 participants 161 participants
14.8
(12.0 to 17.4)
8.3
(7.4 to 9.2)
DoR: Investigator assessment Number Analyzed 171 participants 158 participants
15.9
(13.8 to 17.6)
9.2
(8.2 to 11.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dacomitinib, Gefitinib
Comments Comparison of dacomitinib vs gefitinib based on IRC review
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method 1-sided stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.403
Confidence Interval (2-Sided) 95%
0.307 to 0.529
Estimation Comments Based on stratified Cox regression model
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Dacomitinib, Gefitinib
Comments Comparison of dacomitinib vs gefitinib based on Investigator assessment
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method 1-sided stratified log-rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.545
Confidence Interval (2-Sided) 95%
0.418 to 0.711
Estimation Comments Based on stratified Cox regression model
8.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non- serious adverse events.
Time Frame From baseline up to 28-35 days after last dose of study drug (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 224
Measure Type: Number
Unit of Measure: participants
TEAEs 226 220
SAEs 62 50
9.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities of Grade 3 or Higher Severity Based on NCI CTCAE Version 4.03: Biochemistry and Haematology
Hide Description Laboratory parameters included haematological and biochemistry parameters. Haematology parameters included anaemia, activated partial thromboplastin time, haemoglobin, international normalized ratio, lymphocyte count, lymphopenia, neutrophils (absolute), platelets, prothrombin time and white blood cells. Biochemistry parameters included alanine aminotransferase (increased), alkaline phosphatase (increased), aspartate aminotransferase (increased), bilirubin (total), creatinine (increased), hypercalcaemia, hyperglycaemia, hyperkalaemia, hypermagnesaemia, hypernatraemia, hypoalbuminaemia, hypocalcaemia, hypoglycaemia, hypokalaemia, hypomagnesaemia, hyponatraemia. Test abnormalities were graded by AEs according to the Common Terminology Criteria for Adverse Events(NCI CTCAE) version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure.
Time Frame From baseline up to 28-35 days after last dose of study drug (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 224
Measure Type: Count of Participants
Unit of Measure: Participants
Anaemia (Grade 3)
2
   0.9%
6
   2.7%
Haemoglobin (Grade 3)
0
   0.0%
1
   0.4%
Lymphopenia (Grade 3)
13
   5.7%
6
   2.7%
Lymphopenia (Grade 4)
1
   0.4%
0
   0.0%
Neutrophil count (absolute) (Grade 3)
0
   0.0%
1
   0.4%
WBC count (Grade 3)
1
   0.4%
1
   0.4%
Alanine aminotransferase increased (Grade 3)
3
   1.3%
26
  11.6%
Alanine aminotransferase increased (Grade 4)
0
   0.0%
2
   0.9%
Aspartate aminotransferase increased (Grade 3)
1
   0.4%
15
   6.7%
Aspartate aminotransferase increased (Grade 4)
0
   0.0%
2
   0.9%
Alkaline phosphatase increased (Grade 3)
2
   0.9%
6
   2.7%
Bilirubin increased (total) (Grade 3)
1
   0.4%
1
   0.4%
Creatinine increased (Grade 3)
0
   0.0%
1
   0.4%
Hypercalcaemia (Grade 3)
1
   0.4%
0
   0.0%
Hyperglycaemia (Grade 3)
2
   0.9%
5
   2.2%
Hyperkalaemia (Grade 4)
0
   0.0%
2
   0.9%
Hypermagnesaemia (Grade 3)
7
   3.1%
6
   2.7%
Hypocalcaemia (Grade 3)
3
   1.3%
4
   1.8%
Hypoglycaemia (Grade 3)
0
   0.0%
2
   0.9%
Hypoglycaemia (Grade 4)
1
   0.4%
0
   0.0%
Hypokalaemia (Grade 3)
13
   5.7%
5
   2.2%
Hypokalaemia (Grade 4)
2
   0.9%
0
   0.0%
Hypomagnesaemia (Grade 3)
2
   0.9%
0
   0.0%
Hyponatraemia (Grade 3)
6
   2.6%
5
   2.2%
Hyponatraemia (Grade 4)
1
   0.4%
1
   0.4%
10.Secondary Outcome
Title Number of Participants With Laboratory Test Abnormalities: Urinalysis
Hide Description Urinalysis parameter included urine protein, urine blood/haemoglobin, urine glucose and urine sediment. Test abnormalities was defined as deviation from normal range (higher or lower). Normal range of 24-hour urine protein test: less than 150 mg of protein per day, urine glucose: 0 to 0.8 mmol/L (millimole per liter), urine protein: 0 to 20 mg/dL (milligrams per deciliter). Urine blood/haemoglobin abnormality was defined as presence and absence of blood/haemoglobin in urine of participants. Urine sediment abnormality was defined as the presence of any bacteria, casts, crystals, and epithelial cells. Only categories with at least 1 participant with abnormality are reported in this outcome measure.
Time Frame From baseline up to 28-35 days after last dose of study drug (up to 48 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 224
Measure Type: Count of Participants
Unit of Measure: Participants
High Urine Protein
1
   0.4%
1
   0.4%
Low Urine Glucose
1
   0.4%
0
   0.0%
High Urine Blood/Haemoglobin
4
   1.8%
4
   1.8%
11.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormalities in Vital Signs
Hide Description Criteria for vital signs abnormalities: systolic pulse rate less than (<) 50 beats per minute (bpm) or greater than (>)130 bpm and maximum increase or decrease from baseline in pulse rate of 30 bpm. Systolic blood pressure of maximum increase from baseline (MIB) >=40 millimeters of mercury (mmHg), maximum decrease from baseline (MDB) in systolic blood pressure =<60 mmHg. Diastolic blood pressure of MIB >=20 mmHg and MDB in diastolic blood pressure >40 and =<20 mm Hg. Only categories with at least 1 participant with abnormality are reported in this outcome measure.
Time Frame From baseline up to 28-35 days after last dose of study drug (up to 48 months)
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Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 227 224
Measure Type: Count of Participants
Unit of Measure: Participants
MIB in systolic BP >=40 mmHg
13
   5.7%
20
   8.9%
MDB in systolic BP <=-60 mmHg
0
   0.0%
1
   0.4%
MIB in diastolic BP >=20 mmHg
38
  16.7%
44
  19.6%
MDB in diastolic BP >-40 and <=-20mmHg
46
  20.3%
52
  23.2%
MDB in diastolic BP <=-40 mmHg
0
   0.0%
1
   0.4%
Maximum post baseline pulse rate >130 bpm
2
   0.9%
2
   0.9%
Minimum post baseline pulse rate <50 bpm
2
   0.9%
0
   0.0%
MIB in pulse rate >=30 bpm
13
   5.7%
12
   5.4%
MDB in pulse rate <=-30 bpm
17
   7.5%
16
   7.1%
12.Secondary Outcome
Title Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)
Hide Description ECG parameters included corrected QT interval using Bazett's formula (QTcB) and corrected QT interval using Fridericia's formula (QTcF). ECG criteria for abnormality: absolute value 450 - <480 msec, 480 - <500 msec >=500. The number of participants with potentially clinically significant ECG findings at any visit were reported.
Time Frame From baseline up to 28-35 days after last dose of study drug (up to 48 months)
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Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received. Here, "N" (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 217 7
Measure Type: Number
Unit of Measure: participants
QTcF Criteria: 450-<480 5 0
QTcB Criteria: 450-<480 22 0
QTcB Criteria: 480-<500 3 0
13.Secondary Outcome
Title Number of Participants With Maximum Relative Decrease From Baseline >20% in Left Ventricular Ejection Fraction (LVEF)
Hide Description An ejection fraction (EF) was the volumetric fraction of blood ejected from a ventricle of the heart with each heartbeat; it was a measure of the pumping efficiency of the heart. The EF of the left heart, known as the left ventricular ejection fraction, was a measure of the efficiency of pumping into the body's systemic circulation.
Time Frame From baseline up to 7 days of Cycle 4 (up to 91 days)
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Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study medication, with treatment assignments designated according to actual study treatment received. Here “N” signifies number of participants who were evaluable for this specified outcome measure.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 191 199
Measure Type: Number
Unit of Measure: participants
5 5
14.Secondary Outcome
Title Health Related Quality of Life (HRQOL): Time to Deterioration (TTD) in Pain, Dyspnea, Fatigue or Cough
Hide Description HRQOL was measured by standardized questionnaires (European Organization for Research and Treatment of Cancer (EORTC)) quality of life questionnaires (OLQ-C30) and its lung cancer module (QLQ-LC13). TTD in pain (chest, arm/shoulder), dyspnea, fatigue or cough was defined as time between baseline and first occurrence of increase in score of 10 points or greater from baseline in any of these 4 symptoms for at least two consecutive cycles. For those who had not shown deterioration, the data was censored at the last date when the participants completed an assessment for pain, dyspnea, fatigue or cough.
Time Frame Baseline until the end of treatment (up to 48 months)
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Hide Analysis Population Description
PRO analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 226 222
Median (95% Confidence Interval)
Unit of Measure: months
3.8
(2.3 to 4.8)
6.6
(3.8 to 9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dacomitinib, Gefitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5327
Comments [Not Specified]
Method 2-sided Hochberg adjusted p-value
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.173
Confidence Interval (2-Sided) 95%
0.928 to 1.483
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Overall Mean Scores of Euro Quality of Life-5 Dimension Visual Analog Scale (EQ-5D VAS)
Hide Description The Euro Quality of Life-5 dimension (EQ-5D) is a brief self-administered, validated reliable generic health status instrument. EQ-5D general health status can also be measured by a visual analog scale (EQ-5D VAS). EQ-5D VAS measures the participant's self-rated health status on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time Frame From Cycle 1 to 41 (up to 48 months)
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Hide Analysis Population Description
PRO analysis set included all enrolled participants, who started treatment and completed a baseline PRO assessments and at least one post-baseline PRO assessment after the first dose.
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Participants received 250 mg of gefitinib tablets orally once daily, in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 224 221
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
73.3869
(71.608 to 75.166)
77.6923
(75.895 to 79.490)
16.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Dacomitinib and Its Metabolite PF-05199265
Hide Description [Not Specified]
Time Frame Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
Arm/Group Title Dacomitinib
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Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Dacomitinib 84.19  (21.90)
PF-05199265 12.77  (7.58)
17.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax) of Dacomitinib and Its Metabolite PF-05199265
Hide Description [Not Specified]
Time Frame Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
Arm/Group Title Dacomitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 19
Median (Full Range)
Unit of Measure: hour
Dacomitinib
4.03
(2.0 to 24.0)
PF-05199265
6.0
(0.0 to 25.0)
18.Secondary Outcome
Title Area Under the Plasma Concentration-Time Curve From Time 0 to End of Dosing Interval (AUCtau) of Dacomitinib and Its Metabolite PF-05199265
Hide Description [Not Specified]
Time Frame Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
Arm/Group Title Dacomitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: nanogram*hour/milliliter (ng*hr/mL)
Dacomitinib 1712.08  (413.61)
PF-05199265 278.47  (163.53)
19.Secondary Outcome
Title Averaged Plasma Concentration at Steady State (Cavg) of Dacomitinib and Its Metabolite PF-05199265
Hide Description [Not Specified]
Time Frame Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)
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Hide Analysis Population Description
PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
Arm/Group Title Dacomitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
Dacomitinib 71.33  (17.23)
PF-05199265 11.60  (6.81)
20.Secondary Outcome
Title Minimum Observed Plasma Concentration (Cmin) of Dacomitinib and Its Metabolite PF-05199265
Hide Description [Not Specified]
Time Frame Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
Arm/Group Title Dacomitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
Dacomitinib 60.64  (14.85)
PF-05199265 10.49  (6.26)
21.Secondary Outcome
Title Fluctuation Coefficient Between Trough and Peak Plasma Concentration (DF) of Dacomitinib and Its Metabolite PF-05199265
Hide Description Fluctuation coefficient between trough and peak plasma concentration was determined as Cmax-Ctrough divided by Cavg, where Cmax was the maximum observed concentration within the dosing interval, Ctrough was the observed concentration prior to dose administration and Cavg was averaged plasma concentration at steady state.
Time Frame Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
Arm/Group Title Dacomitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: Fluctuation coefficient
Dacomitinib 0.2883  (0.1460)
PF-05199265 0.1105  (0.0827)
22.Secondary Outcome
Title Apparent Clearance (CL) of Dacomitinib
Hide Description Drug clearance was a quantitative measure of the rate at which a drug substance was removed from the blood (rate at which a drug is metabolized or eliminated by normal biological processes).
Time Frame Pre-dose and 2, 4, 6, 8, and 24 hours post-dose on Cycle 2 Day 1 (Day 29)
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who were treated with dacomitinib with at least 1 measured plasma concentration and were dose-compliant (who received 45 mg dacomitinib daily without interruptions/dose reductions for at least 14 days prior to day of data collection). This outcome measure was planned to be analyzed in Chinese subgroup only.
Arm/Group Title Dacomitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: Liter/hour (L/h)
27.61  (5.97)
23.Secondary Outcome
Title Pre-dose Plasma Concentrations (Ctrough) of Dacomitinib and Its Metabolite PF-05199265
Hide Description Trough plasma concentration was defined as the measured concentration at the end of a dosing interval at steady state (taken directly before next administration).
Time Frame Pre-dose on Day 1 of Cycle 2, 3, 4, 5 and 6
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Hide Analysis Population Description
PK analysis set included all participants who were treated with dacomitinib with at least one measured plasma concentration and were dose-compliant. Dose-compliant participants were those who received 45 mg dacomitinib daily without interruptions or dose reductions for at least 14 days prior to the day of data collection.
Arm/Group Title Dacomitinib
Hide Arm/Group Description:
Participants received 45 mg of dacomitinib tablets orally once daily in each treatment cycle of 28 days, up to a maximum duration of 48 months until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
Overall Number of Participants Analyzed 188
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 2 Day 1: Dacomitinib Number Analyzed 176 participants
70.24  (27.16)
Cycle 3 Day 1: Dacomitinib Number Analyzed 143 participants
68.34  (25.80)
Cycle 4 Day 1: Dacomitinib Number Analyzed 112 participants
68.16  (25.49)
Cycle 5 Day 1: Dacomitinib Number Analyzed 85 participants
64.50  (25.52)
Cycle 6 Day 1: Dacomitinib Number Analyzed 74 participants
61.68  (22.58)
Cycle 2 Day 1: PF-05199265 Number Analyzed 176 participants
13.20  (8.55)
Cycle 3 Day 1: PF-05199265 Number Analyzed 143 participants
14.42  (9.10)
Cycle 4 Day 1: PF-05199265 Number Analyzed 112 participants
13.70  (8.33)
Cycle 5 Day 1: PF-05199265 Number Analyzed 85 participants
12.48  (6.69)
Cycle 6 Day 1: PF-05199265 Number Analyzed 74 participants
13.05  (6.52)
Time Frame From baseline until 35 days after the last dose of study drug (up to 40 months)
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study.
 
Arm/Group Title Dacomitinib Gefitinib
Hide Arm/Group Description Participants received 45 mg of dacomitinib tablets orally once daily, up to a maximum of 41 cycles (each cycle of 28 days) until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first. Participants received 250 mg of gefitinib tablets orally once daily, up to a maximum of 38 cycles (each cycle of 28 days) until disease progression, intolerable toxicities, withdrawal, death, or investigator decision dictated by protocol compliance, whichever occurred first.
All-Cause Mortality
Dacomitinib Gefitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   76/227 (33.48%)   91/224 (40.63%) 
Show Serious Adverse Events Hide Serious Adverse Events
Dacomitinib Gefitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   62/227 (27.31%)   50/224 (22.32%) 
Blood and lymphatic system disorders     
Leukocytosis * 1  1/227 (0.44%)  0/224 (0.00%) 
Cardiac disorders     
Cardiac tamponade * 1  1/227 (0.44%)  0/224 (0.00%) 
Arteriosclerosis coronary artery * 2  0/227 (0.00%)  1/224 (0.45%) 
Eye disorders     
Keratitis * 2  1/227 (0.44%)  0/224 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 2  5/227 (2.20%)  0/224 (0.00%) 
Abdominal pain * 2  2/227 (0.88%)  0/224 (0.00%) 
Abdominal distension * 2  1/227 (0.44%)  0/224 (0.00%) 
Gastric ulcer haemorrhage * 2  1/227 (0.44%)  0/224 (0.00%) 
Ileus * 2  1/227 (0.44%)  0/224 (0.00%) 
Mouth haemorrhage * 2  1/227 (0.44%)  0/224 (0.00%) 
Rectal haemorrhage * 2  1/227 (0.44%)  0/224 (0.00%) 
Stomatitis * 2  1/227 (0.44%)  0/224 (0.00%) 
Vomiting * 2  1/227 (0.44%)  0/224 (0.00%) 
Dyspepsia * 2  0/227 (0.00%)  1/224 (0.45%) 
Haematochezia * 2  0/227 (0.00%)  1/224 (0.45%) 
Large intestinal obstruction * 1  0/227 (0.00%)  1/224 (0.45%) 
General disorders     
Disease progression * 2  8/227 (3.52%)  11/224 (4.91%) 
Death * 2  1/227 (0.44%)  1/224 (0.45%) 
Multiple organ dysfunction syndrome * 2  1/227 (0.44%)  0/224 (0.00%) 
Non-cardiac chest pain * 2  1/227 (0.44%)  0/224 (0.00%) 
Pyrexia * 2  1/227 (0.44%)  0/224 (0.00%) 
General physical health deterioration * 2  0/227 (0.00%)  1/224 (0.45%) 
Hepatobiliary disorders     
Liver injury * 2  2/227 (0.88%)  1/224 (0.45%) 
Drug-induced liver injury * 2  1/227 (0.44%)  1/224 (0.45%) 
Bile duct stone * 2  0/227 (0.00%)  1/224 (0.45%) 
Cholecystitis acute * 2  0/227 (0.00%)  1/224 (0.45%) 
Infections and infestations     
Pneumonia * 2  5/227 (2.20%)  2/224 (0.89%) 
Respiratory tract infection * 2  2/227 (0.88%)  1/224 (0.45%) 
Urinary tract infection * 2  2/227 (0.88%)  0/224 (0.00%) 
Bronchitis * 2  1/227 (0.44%)  0/224 (0.00%) 
Bronchopulmonary aspergillosis * 2  1/227 (0.44%)  0/224 (0.00%) 
Diverticulitis * 2  1/227 (0.44%)  0/224 (0.00%) 
Escherichia urinary tract infection * 2  1/227 (0.44%)  0/224 (0.00%) 
Gastroenteritis * 2  1/227 (0.44%)  0/224 (0.00%) 
Infection * 1  1/227 (0.44%)  0/224 (0.00%) 
Lung infection * 2  1/227 (0.44%)  1/224 (0.45%) 
Upper respiratory tract infection * 2  1/227 (0.44%)  0/224 (0.00%) 
Herpes zoster * 2  0/227 (0.00%)  1/224 (0.45%) 
Injury, poisoning and procedural complications     
Facial bones fracture * 2  1/227 (0.44%)  0/224 (0.00%) 
Hip fracture * 2  1/227 (0.44%)  1/224 (0.45%) 
Overdose * 1  1/227 (0.44%)  0/224 (0.00%) 
Spinal fracture * 2  1/227 (0.44%)  0/224 (0.00%) 
Extradural haematoma * 2  0/227 (0.00%)  1/224 (0.45%) 
Subdural haematoma * 2  0/227 (0.00%)  2/224 (0.89%) 
Tibia fracture * 2  0/227 (0.00%)  1/224 (0.45%) 
Investigations     
Alanine aminotransferase increased * 2  0/227 (0.00%)  1/224 (0.45%) 
Aspartate aminotransferase increased * 2  0/227 (0.00%)  1/224 (0.45%) 
Hepatic enzyme increased * 2  0/227 (0.00%)  2/224 (0.89%) 
Metabolism and nutrition disorders     
Decreased appetite * 2  2/227 (0.88%)  0/224 (0.00%) 
Dehydration * 2  1/227 (0.44%)  0/224 (0.00%) 
Malnutrition * 2  1/227 (0.44%)  1/224 (0.45%) 
Hyponatraemia * 2  0/227 (0.00%)  2/224 (0.89%) 
Musculoskeletal and connective tissue disorders     
Bone pain * 1  1/227 (0.44%)  0/224 (0.00%) 
Muscular weakness * 2  1/227 (0.44%)  0/224 (0.00%) 
Musculoskeletal pain * 2  1/227 (0.44%)  0/224 (0.00%) 
Back pain * 2  0/227 (0.00%)  1/224 (0.45%) 
Polymyalgia rheumatica * 2  0/227 (0.00%)  1/224 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma * 2  1/227 (0.44%)  0/224 (0.00%) 
Chronic myeloid leukaemia * 2  1/227 (0.44%)  0/224 (0.00%) 
Metastases to meninges * 2  1/227 (0.44%)  0/224 (0.00%) 
Malignant neoplasm progression * 2  0/227 (0.00%)  1/224 (0.45%) 
Pancreatic carcinoma * 2  0/227 (0.00%)  1/224 (0.45%) 
Nervous system disorders     
Cerebral infarction * 2  1/227 (0.44%)  2/224 (0.89%) 
Cerebral venous thrombosis * 2  1/227 (0.44%)  0/224 (0.00%) 
Spinal cord compression * 2  1/227 (0.44%)  0/224 (0.00%) 
Cerebrovascular accident * 2  0/227 (0.00%)  1/224 (0.45%) 
Cognitive disorder * 2  0/227 (0.00%)  1/224 (0.45%) 
Dizziness * 2  0/227 (0.00%)  1/224 (0.45%) 
Post herpetic neuralgia * 2  0/227 (0.00%)  1/224 (0.45%) 
Psychiatric disorders     
Depression * 1  0/227 (0.00%)  1/224 (0.45%) 
Suicide attempt * 2  0/227 (0.00%)  1/224 (0.45%) 
Renal and urinary disorders     
Acute kidney injury * 2  1/227 (0.44%)  0/224 (0.00%) 
Ureterolithiasis * 2  0/227 (0.00%)  1/224 (0.45%) 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 2  5/227 (2.20%)  2/224 (0.89%) 
Haemoptysis * 2  2/227 (0.88%)  0/224 (0.00%) 
Pneumonitis * 2  2/227 (0.88%)  1/224 (0.45%) 
Pneumothorax * 2  2/227 (0.88%)  0/224 (0.00%) 
Respiratory failure * 2  2/227 (0.88%)  0/224 (0.00%) 
Dyspnoea * 2  1/227 (0.44%)  4/224 (1.79%) 
Interstitial lung disease * 2  1/227 (0.44%)  1/224 (0.45%) 
Pulmonary embolism * 1  1/227 (0.44%)  0/224 (0.00%) 
Bronchospasm * 1  0/227 (0.00%)  1/224 (0.45%) 
Organizing pneumonia * 2  0/227 (0.00%)  1/224 (0.45%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform * 2  1/227 (0.44%)  0/224 (0.00%) 
Drug eruption * 2  1/227 (0.44%)  0/224 (0.00%) 
Rash maculo-papular * 2  1/227 (0.44%)  0/224 (0.00%) 
Decubitus ulcer * 2  0/227 (0.00%)  1/224 (0.45%) 
Vascular disorders     
Deep vein thrombosis * 2  1/227 (0.44%)  0/224 (0.00%) 
1
Term from vocabulary, 19.1
2
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dacomitinib Gefitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   224/227 (98.68%)   217/224 (96.88%) 
Blood and lymphatic system disorders     
Anaemia * 1  22/227 (9.69%)  16/224 (7.14%) 
Gastrointestinal disorders     
Diarrhoea * 1  198/227 (87.22%)  125/224 (55.80%) 
Stomatitis * 2  99/227 (43.61%)  40/224 (17.86%) 
Nausea * 2  43/227 (18.94%)  49/224 (21.88%) 
Constipation * 2  30/227 (13.22%)  31/224 (13.84%) 
Mouth ulceration * 2  28/227 (12.33%)  13/224 (5.80%) 
Vomiting * 2  20/227 (8.81%)  29/224 (12.95%) 
Aphthous ulcer * 2  13/227 (5.73%)  6/224 (2.68%) 
Oral pain * 2  12/227 (5.29%)  1/224 (0.45%) 
Abdominal pain * 2  10/227 (4.41%)  12/224 (5.36%) 
Dysphagia * 2  10/227 (4.41%)  12/224 (5.36%) 
Abdominal pain upper * 2  9/227 (3.96%)  14/224 (6.25%) 
General disorders     
Asthenia * 2  29/227 (12.78%)  28/224 (12.50%) 
Chest pain * 2  22/227 (9.69%)  32/224 (14.29%) 
Fatigue * 2  21/227 (9.25%)  19/224 (8.48%) 
Mucosal inflammation * 2  21/227 (9.25%)  8/224 (3.57%) 
Pyrexia * 2  19/227 (8.37%)  17/224 (7.59%) 
Oedema peripheral * 1  13/227 (5.73%)  7/224 (3.13%) 
Pain * 2  11/227 (4.85%)  12/224 (5.36%) 
Infections and infestations     
Paronychia * 2  140/227 (61.67%)  45/224 (20.09%) 
Conjunctivitis * 2  43/227 (18.94%)  9/224 (4.02%) 
Upper respiratory tract infection * 2  27/227 (11.89%)  28/224 (12.50%) 
Nasopharyngitis * 2  21/227 (9.25%)  19/224 (8.48%) 
Rash pustular * 2  14/227 (6.17%)  3/224 (1.34%) 
Urinary tract infection * 2  14/227 (6.17%)  8/224 (3.57%) 
Investigations     
Weight decreased * 2  58/227 (25.55%)  37/224 (16.52%) 
Alanine aminotransferase increased * 2  44/227 (19.38%)  88/224 (39.29%) 
Aspartate aminotransferase increased * 2  42/227 (18.50%)  81/224 (36.16%) 
Blood bilirubin increased * 2  20/227 (8.81%)  19/224 (8.48%) 
Blood alkaline phosphatase increased * 2  14/227 (6.17%)  7/224 (3.13%) 
Gamma-glutamyltransferase increased * 2  14/227 (6.17%)  20/224 (8.93%) 
White blood cell count decreased * 2  6/227 (2.64%)  14/224 (6.25%) 
Weight increased * 2  5/227 (2.20%)  12/224 (5.36%) 
Metabolism and nutrition disorders     
Decreased appetite * 2  69/227 (30.40%)  56/224 (25.00%) 
Hypokalaemia * 2  22/227 (9.69%)  13/224 (5.80%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity * 1  31/227 (13.66%)  26/224 (11.61%) 
Musculoskeletal pain * 2  26/227 (11.45%)  28/224 (12.50%) 
Back pain * 2  18/227 (7.93%)  34/224 (15.18%) 
Arthralgia * 2  16/227 (7.05%)  15/224 (6.70%) 
Nervous system disorders     
Dysgeusia * 2  16/227 (7.05%)  11/224 (4.91%) 
Paraesthesia * 1  16/227 (7.05%)  11/224 (4.91%) 
Headache * 2  14/227 (6.17%)  19/224 (8.48%) 
Dizziness * 2  11/227 (4.85%)  17/224 (7.59%) 
Psychiatric disorders     
Insomnia * 2  24/227 (10.57%)  33/224 (14.73%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 2  48/227 (21.15%)  42/224 (18.75%) 
Dyspnoea * 2  29/227 (12.78%)  28/224 (12.50%) 
Epistaxis * 2  21/227 (9.25%)  5/224 (2.23%) 
Nasal inflammation * 2  15/227 (6.61%)  3/224 (1.34%) 
Haemoptysis * 2  10/227 (4.41%)  13/224 (5.80%) 
Productive cough * 2  9/227 (3.96%)  12/224 (5.36%) 
Skin and subcutaneous tissue disorders     
Dermatitis acneiform * 1  111/227 (48.90%)  64/224 (28.57%) 
Dry skin * 2  63/227 (27.75%)  38/224 (16.96%) 
Alopecia * 2  53/227 (23.35%)  28/224 (12.50%) 
Pruritus * 2  45/227 (19.82%)  32/224 (14.29%) 
Rash * 2  40/227 (17.62%)  24/224 (10.71%) 
Palmar-plantar erythrodysaesthesia syndrome * 2  33/227 (14.54%)  7/224 (3.13%) 
Rash maculo-papular * 2  28/227 (12.33%)  27/224 (12.05%) 
Dermatitis * 2  25/227 (11.01%)  9/224 (4.02%) 
Skin fissures * 2  21/227 (9.25%)  6/224 (2.68%) 
Acne * 2  20/227 (8.81%)  13/224 (5.80%) 
Erythema * 2  12/227 (5.29%)  3/224 (1.34%) 
Vascular disorders     
Hypertension * 2  13/227 (5.73%)  10/224 (4.46%) 
1
Term from vocabulary, 19.1
2
Term from vocabulary, MedDRA 19.1
*
Indicates events were collected by non-systematic assessment
Data for overall survival is not reported at Primary completion date and will be reported after the study completion date.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: SFJ Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01774721     History of Changes
Other Study ID Numbers: DP312804
First Submitted: January 21, 2013
First Posted: January 24, 2013
Results First Submitted: March 29, 2018
Results First Posted: October 26, 2018
Last Update Posted: April 17, 2019