PF-00299804 in Stage IIIB or Stage IV Non-Small Cell Lung Cancer Not Responding to Standard Therapy for Advanced or Metastatic Cancer

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ClinicalTrials.gov Identifier: NCT01000025

Recruitment Status : Completed

First Posted : October 22, 2009

Results First Posted : October 27, 2014

Last Update Posted : August 22, 2023

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Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition	Lung Cancer
Interventions	Drug: PF-00299804 Drug: Placebo
Enrollment	720

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	PF-804	Placebo
Arm/Group Description	Study treatment arm	Control arm
Arm/Group Description	Study treatment arm	Control arm
Period Title: Overall Study
Started	480	240
Completed	12	2
Not Completed	468	238
Reason Not Completed
Adverse Event	43	2
Withdrawal by Subject	13	8
Death	23	13
Lack of Efficacy	363	208
Intercurrent Illness	26	7

Baseline Characteristics

Arm/Group Title		PF-00299804	Placebo	Total
Arm/Group Description		Patients receive oral PF-00299804 o...	Patients receive oral placebo once ...	Total of all reporting groups
Arm/Group Description		Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PF-00299804: PF-804 45 mg PO, daily	Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Placebo: Placebo 45 mg PO, daily	Total of all reporting groups
Overall Number of Baseline Participants		480	240	720
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	480 participants	240 participants	720 participants
		63.5 (32 to 86)	65.5 (34 to 90)	64 (32 to 90)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	480 participants	240 participants	720 participants
	Female	236 49.2%	120 50.0%	356 49.4%
	Male	244 50.8%	120 50.0%	364 50.6%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	480 participants	240 participants	720 participants
	American Indian or Alaska Native	2 0.4%	0 0.0%	2 0.3%
	Asian	172 35.8%	87 36.3%	259 36.0%
	Native Hawaiian or Other Pacific Islander	1 0.2%	0 0.0%	1 0.1%
	Black or African American	4 0.8%	1 0.4%	5 0.7%
	White	288 60.0%	144 60.0%	432 60.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	13 2.7%	8 3.3%	21 2.9%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	480 participants	240 participants	720 participants
United States		1	1	2
Philippines		20	11	31
Taiwan		11	6	17
Canada		207	101	308
Thailand		28	14	42
Brazil		25	14	39
Peru		0	1	1
Australia		50	27	77
New Zealand		7	4	11
Italy		77	34	111
Korea, Republic of		47	24	71
Argentina		7	3	10

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	Median and 95% confidence intervals
Description	Median and 95% confidence intervals
Time Frame	42 Months

Outcome Measure Data

Analysis Population Description

ITT


Arm/Group Title	PF-00299804	Placebo
Arm/Group Description:	Patients receive oral PF-00299804 o...	Patients receive oral placebo once ...
Arm/Group Description:	Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PF-00299804: PF-804 45 mg PO, daily	Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Placebo: Placebo 45 mg PO, daily
Overall Number of Participants Analyzed	480	240
Median (95% Confidence Interval) Unit of Measure: Months
	6.83 (6.08 to 7.49)	6.31 (5.32 to 7.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-00299804, Placebo
	Comments	The trial was designed to detect a 25% deduction in risk of death with PF-804 with 90% power using a 1-sided 2.5% level significance test. The sample size was estimated as 720 patients.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.506
	Comments	Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.1-sied p-value.
	Method	Log Rank
	Comments	Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95% 0.83 to 1.21
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival in KRAS-WT Patients
Description	Median and 95% confidence intervals of Overall survival in KRAS-WT pat...
Description	Median and 95% confidence intervals of Overall survival in KRAS-WT patients
Time Frame	42 Months

Outcome Measure Data

Analysis Population Description

Patients with K-Ras mutation wild type


Arm/Group Title	PF-00299804	Placebo
Arm/Group Description:	Patients receive oral PF-00299804 o...	Patients receive oral placebo once ...
Arm/Group Description:	Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PF-00299804: PF-804 45 mg PO, daily	Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Placebo: Placebo 45 mg PO, daily
Overall Number of Participants Analyzed	220	120
Median (95% Confidence Interval) Unit of Measure: Months
	7.00 (6.01 to 8.21)	5.19 (4.53 to 7.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-00299804, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.043
	Comments	1-sided p-value
	Method	Log Rank
	Comments	Stratified by stratification factors at randomization except study center.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 95% 0.61 to 1.03
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Overall Survival in EGFR-mutant Patients
Description	Overall survival by EGFR-mutantion subgroups
Description	Overall survival by EGFR-mutantion subgroups
Time Frame	42 Months

Outcome Measure Data

Analysis Population Description

Patients with EGFR mutation


Arm/Group Title	PF-00299804	Placebo
Arm/Group Description:	Patients receive oral PF-00299804 o...	Patients receive oral placebo once ...
Arm/Group Description:	Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PF-00299804: PF-804 45 mg PO, daily	Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Placebo: Placebo 45 mg PO, daily
Overall Number of Participants Analyzed	114	68
Median (95% Confidence Interval) Unit of Measure: Months
	7.23 (6.08 to 8.61)	7.52 (4.99 to 9.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-00299804, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.46
	Comments	1-sided pvalue
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95% 0.67 to 1.44
	Estimation Comments	[Not Specified]

4.Secondary Outcome


Title	Progression-free Survival
Description	progression were evaluated using the revised international criteria (1...
Description	progression were evaluated using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee
Time Frame	42 Months

Outcome Measure Data

Analysis Population Description

ITT


Arm/Group Title	PF-00299804	Placebo
Arm/Group Description:	Patients receive oral PF-00299804 o...	Patients receive oral placebo once ...
Arm/Group Description:	Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PF-00299804: PF-804 45 mg PO, daily	Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Placebo: Placebo 45 mg PO, daily
Overall Number of Participants Analyzed	480	240
Median (95% Confidence Interval) Unit of Measure: Months
	2.66 (1.91 to 3.32)	1.58 (0.99 to 1.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-00299804, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	< 0.0001
	Comments	[Not Specified]
	Method	Log Rank
	Comments	Stratified by stratification factors at randomization except study center, but included K-Ras mutation status.

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.66
	Confidence Interval	(2-Sided) 95% 0.55 to 0.79
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Objective Response Rate
Description	Response were evaluated in this study using the revised international ...
Description	Response were evaluated in this study using the revised international criteria (1.1) proposed by the RECIST (Response Evaluation Criteria in Solid Tumours) committee. BEST RESPONSE from the start of study treatment until the end of treatment were reported.Objective response rate is the sum of CR + PR divided by the total number of patients in each group.
Time Frame	42 months

Outcome Measure Data

Analysis Population Description

ITT


Arm/Group Title	PF-00299804	Placebo
Arm/Group Description:	Patients receive oral PF-00299804 o...	Patients receive oral placebo once ...
Arm/Group Description:	Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PF-00299804: PF-804 45 mg PO, daily	Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Placebo: Placebo 45 mg PO, daily
Overall Number of Participants Analyzed	480	240
Mean (95% Confidence Interval) Unit of Measure: percentage of participants
	7.1 (4.8 to 9.4)	1.3 (0.0 to 2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PF-00299804, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	6.11
	Confidence Interval	(2-Sided) 95% 1.84 to 20.3
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0
Description	Number of participants with Toxicities by treatment received according...
Description	Number of participants with Toxicities by treatment received according to NCI CTCAE version 4.0
Time Frame	42 Months

Outcome Measure Data

Analysis Population Description

As treated population


Arm/Group Title	PF-00299804	Placebo
Arm/Group Description:	Patients receive oral PF-00299804 o...	Patients receive oral placebo once ...
Arm/Group Description:	Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PF-00299804: PF-804 45 mg PO, daily	Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Placebo: Placebo 45 mg PO, daily
Overall Number of Participants Analyzed	477	239
Measure Type: Number Unit of Measure: participants
	467	223

Adverse Events

Time Frame	42 Months
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	PF-00299804	Placebo
Arm/Group Description	Patients receive oral PF-00299804 o...	Patients receive oral placebo once ...
Arm/Group Description	Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. PF-00299804: PF-804 45 mg PO, daily	Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Placebo: Placebo 45 mg PO, daily
All-Cause Mortality
	PF-00299804	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	PF-00299804	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	191/477 (40.04%)	87/239 (36.40%)
Blood and lymphatic system disorders
Anemia ^†	1/477 (0.21%)	0/239 (0.00%)
Febrile neutropenia ^†	1/477 (0.21%)	1/239 (0.42%)
Cardiac disorders
Atrial fibrillation ^†	0/477 (0.00%)	1/239 (0.42%)
Cardiac arrest ^†	1/477 (0.21%)	0/239 (0.00%)
Myocardial infarction ^†	1/477 (0.21%)	1/239 (0.42%)
Pericardial effusion ^†	1/477 (0.21%)	2/239 (0.84%)
Pericardial tamponade ^†	0/477 (0.00%)	1/239 (0.42%)
Pericarditis ^†	1/477 (0.21%)	0/239 (0.00%)
Ear and labyrinth disorders
Hearing impaired ^†	1/477 (0.21%)	0/239 (0.00%)
Endocrine disorders
Adrenal insufficiency ^†	0/477 (0.00%)	1/239 (0.42%)
Eye disorders
Cataract ^†	1/477 (0.21%)	0/239 (0.00%)
Corneal ulcer ^†	1/477 (0.21%)	0/239 (0.00%)
Gastrointestinal disorders
Abdominal distension ^†	1/477 (0.21%)	0/239 (0.00%)
Abdominal pain ^†	4/477 (0.84%)	3/239 (1.26%)
Anal hemorrhage ^†	1/477 (0.21%)	0/239 (0.00%)
Ascites ^†	1/477 (0.21%)	0/239 (0.00%)
Colitis ^†	1/477 (0.21%)	0/239 (0.00%)
Colonic obstruction ^†	1/477 (0.21%)	0/239 (0.00%)
Constipation ^†	3/477 (0.63%)	0/239 (0.00%)
Diarrhea ^†	17/477 (3.56%)	1/239 (0.42%)
Dysphagia ^†	0/477 (0.00%)	2/239 (0.84%)
Esophageal stenosis ^†	0/477 (0.00%)	1/239 (0.42%)
Gastrointestinal pain ^†	1/477 (0.21%)	0/239 (0.00%)
Ileus ^†	0/477 (0.00%)	1/239 (0.42%)
Mucositis oral ^†	5/477 (1.05%)	0/239 (0.00%)
Nausea ^†	5/477 (1.05%)	0/239 (0.00%)
Obstruction gastric ^†	0/477 (0.00%)	1/239 (0.42%)
Pancreatitis ^†	1/477 (0.21%)	0/239 (0.00%)
Small intestinal obstruction ^†	1/477 (0.21%)	0/239 (0.00%)
Upper gastrointestinal hemorrhage ^†	0/477 (0.00%)	1/239 (0.42%)
Vomiting ^†	8/477 (1.68%)	3/239 (1.26%)
General disorders
Chills ^†	1/477 (0.21%)	0/239 (0.00%)
Death NOS ^†	2/477 (0.42%)	0/239 (0.00%)
Fatigue ^†	4/477 (0.84%)	2/239 (0.84%)
Fever ^†	7/477 (1.47%)	1/239 (0.42%)
Gait disturbance ^†	1/477 (0.21%)	0/239 (0.00%)
Infusion site extravasation ^†	1/477 (0.21%)	0/239 (0.00%)
Non-cardiac chest pain ^†	1/477 (0.21%)	0/239 (0.00%)
Pain ^†	2/477 (0.42%)	1/239 (0.42%)
Sudden death NOS ^†	1/477 (0.21%)	2/239 (0.84%)
Hepatobiliary disorders
Hepatic failure ^†	1/477 (0.21%)	0/239 (0.00%)
Infections and infestations
Bronchial infection ^†	1/477 (0.21%)	1/239 (0.42%)
Enterocolitis infectious ^†	1/477 (0.21%)	0/239 (0.00%)
Lung infection ^†	32/477 (6.71%)	12/239 (5.02%)
Lymph gland infection ^†	1/477 (0.21%)	0/239 (0.00%)
Mucosal infection ^†	1/477 (0.21%)	0/239 (0.00%)
Other infections and infestations ^†	1/477 (0.21%)	0/239 (0.00%)
Scrotal infection ^†	1/477 (0.21%)	0/239 (0.00%)
Sepsis ^†	2/477 (0.42%)	3/239 (1.26%)
Skin infection ^†	1/477 (0.21%)	0/239 (0.00%)
Urinary tract infection ^†	2/477 (0.42%)	0/239 (0.00%)
Injury, poisoning and procedural complications
Fall ^†	1/477 (0.21%)	0/239 (0.00%)
Fracture ^†	3/477 (0.63%)	1/239 (0.42%)
Hip fracture ^†	3/477 (0.63%)	0/239 (0.00%)
Investigations
Neutrophil count decreased ^†	0/477 (0.00%)	1/239 (0.42%)
Weight loss ^†	0/477 (0.00%)	1/239 (0.42%)
Metabolism and nutrition disorders
Anorexia ^†	3/477 (0.63%)	1/239 (0.42%)
Dehydration ^†	16/477 (3.35%)	0/239 (0.00%)
Hypercalcemia ^†	0/477 (0.00%)	1/239 (0.42%)
Hyperglycemia ^†	0/477 (0.00%)	1/239 (0.42%)
Hypokalemia ^†	1/477 (0.21%)	0/239 (0.00%)
Hyponatremia ^†	1/477 (0.21%)	0/239 (0.00%)
Musculoskeletal and connective tissue disorders
Back pain ^†	2/477 (0.42%)	2/239 (0.84%)
Bone pain ^†	1/477 (0.21%)	0/239 (0.00%)
Chest wall pain ^†	1/477 (0.21%)	1/239 (0.42%)
Generalized muscle weakness ^†	2/477 (0.42%)	0/239 (0.00%)
Pain in extremity ^†	2/477 (0.42%)	0/239 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other neoplasms benign, malignant and unspecified ^†	79/477 (16.56%)	43/239 (17.99%)
Tumor pain ^†	2/477 (0.42%)	0/239 (0.00%)
Nervous system disorders
Cognitive disturbance ^†	0/477 (0.00%)	1/239 (0.42%)
Depressed level of consciousness ^†	4/477 (0.84%)	0/239 (0.00%)
Dizziness ^†	2/477 (0.42%)	1/239 (0.42%)
Dysphasia ^†	1/477 (0.21%)	0/239 (0.00%)
Encephalopathy ^†	1/477 (0.21%)	0/239 (0.00%)
Intracranial hemorrhage ^†	0/477 (0.00%)	1/239 (0.42%)
Ischemia cerebrovascular ^†	1/477 (0.21%)	0/239 (0.00%)
Other nervous system disorders ^†	1/477 (0.21%)	0/239 (0.00%)
Paresthesia ^†	0/477 (0.00%)	1/239 (0.42%)
Seizure ^†	1/477 (0.21%)	0/239 (0.00%)
Sinus pain ^†	1/477 (0.21%)	0/239 (0.00%)
Stroke ^†	2/477 (0.42%)	3/239 (1.26%)
Syncope ^†	0/477 (0.00%)	1/239 (0.42%)
Transient ischemic attacks ^†	0/477 (0.00%)	1/239 (0.42%)
Psychiatric disorders
Confusion ^†	3/477 (0.63%)	1/239 (0.42%)
Personality change ^†	0/477 (0.00%)	1/239 (0.42%)
Renal and urinary disorders
Acute kidney injury ^†	6/477 (1.26%)	0/239 (0.00%)
Respiratory, thoracic and mediastinal disorders
Aspiration ^†	0/477 (0.00%)	1/239 (0.42%)
Bronchopulmonary hemorrhage ^†	6/477 (1.26%)	4/239 (1.67%)
Cough ^†	0/477 (0.00%)	1/239 (0.42%)
Dyspnea ^†	26/477 (5.45%)	14/239 (5.86%)
Epistaxis ^†	2/477 (0.42%)	0/239 (0.00%)
Hoarseness ^†	1/477 (0.21%)	0/239 (0.00%)
Hypoxia ^†	4/477 (0.84%)	0/239 (0.00%)
Pleural effusion ^†	7/477 (1.47%)	3/239 (1.26%)
Pleuritic pain ^†	1/477 (0.21%)	0/239 (0.00%)
Pneumonitis ^†	2/477 (0.42%)	0/239 (0.00%)
Pneumothorax ^†	2/477 (0.42%)	1/239 (0.42%)
Productive cough ^†	1/477 (0.21%)	0/239 (0.00%)
Pulmonary edema ^†	1/477 (0.21%)	0/239 (0.00%)
Respiratory failure ^†	6/477 (1.26%)	2/239 (0.84%)
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders ^†	2/477 (0.42%)	1/239 (0.42%)
Rash acneiform ^†	2/477 (0.42%)	0/239 (0.00%)
Stevens-Johnson syndrome ^†	1/477 (0.21%)	0/239 (0.00%)
Vascular disorders
Hypotension ^†	0/477 (0.00%)	1/239 (0.42%)
Other vascular disorders ^†	0/477 (0.00%)	1/239 (0.42%)
Thromboembolic event ^†	12/477 (2.52%)	3/239 (1.26%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	PF-00299804	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	465/477 (97.48%)	219/239 (91.63%)
Eye disorders
Conjunctivitis ^†	47/477 (9.85%)	0/239 (0.00%)
Dry eye ^†	41/477 (8.60%)	5/239 (2.09%)
Gastrointestinal disorders
Abdominal pain ^†	61/477 (12.79%)	18/239 (7.53%)
Constipation ^†	120/477 (25.16%)	74/239 (30.96%)
Diarrhea ^†	380/477 (79.66%)	47/239 (19.67%)
Dry mouth ^†	50/477 (10.48%)	11/239 (4.60%)
Dyspepsia ^†	39/477 (8.18%)	12/239 (5.02%)
Gastroesophageal reflux disease ^†	30/477 (6.29%)	9/239 (3.77%)
Mucositis oral ^†	206/477 (43.19%)	8/239 (3.35%)
Nausea ^†	168/477 (35.22%)	59/239 (24.69%)
Vomiting ^†	134/477 (28.09%)	37/239 (15.48%)
General disorders
Edema limbs ^†	57/477 (11.95%)	28/239 (11.72%)
Fatigue ^†	254/477 (53.25%)	115/239 (48.12%)
Fever ^†	42/477 (8.81%)	15/239 (6.28%)
Non-cardiac chest pain ^†	33/477 (6.92%)	21/239 (8.79%)
Pain ^†	93/477 (19.50%)	50/239 (20.92%)
Infections and infestations
Lung infection ^†	25/477 (5.24%)	6/239 (2.51%)
Paronychia ^†	142/477 (29.77%)	0/239 (0.00%)
Investigations
Weight loss ^†	73/477 (15.30%)	23/239 (9.62%)
Metabolism and nutrition disorders
Anorexia ^†	222/477 (46.54%)	93/239 (38.91%)
Musculoskeletal and connective tissue disorders
Back pain ^†	83/477 (17.40%)	47/239 (19.67%)
Bone pain ^†	48/477 (10.06%)	20/239 (8.37%)
Chest wall pain ^†	41/477 (8.60%)	27/239 (11.30%)
Pain in extremity ^†	79/477 (16.56%)	35/239 (14.64%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain ^†	31/477 (6.50%)	13/239 (5.44%)
Nervous system disorders
Dizziness ^†	55/477 (11.53%)	25/239 (10.46%)
Dysgeusia ^†	34/477 (7.13%)	4/239 (1.67%)
Headache ^†	53/477 (11.11%)	29/239 (12.13%)
Peripheral sensory neuropathy ^†	84/477 (17.61%)	32/239 (13.39%)
Psychiatric disorders
Anxiety ^†	30/477 (6.29%)	20/239 (8.37%)
Insomnia ^†	84/477 (17.61%)	45/239 (18.83%)
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage ^†	25/477 (5.24%)	14/239 (5.86%)
Cough ^†	233/477 (48.85%)	108/239 (45.19%)
Dyspnea ^†	276/477 (57.86%)	132/239 (55.23%)
Epistaxis ^†	72/477 (15.09%)	4/239 (1.67%)
Productive cough ^†	58/477 (12.16%)	32/239 (13.39%)
Sore throat ^†	26/477 (5.45%)	3/239 (1.26%)
Skin and subcutaneous tissue disorders
Alopecia ^†	25/477 (5.24%)	11/239 (4.60%)
Dry skin ^†	171/477 (35.85%)	27/239 (11.30%)
Other skin and subcutaneous tissue disorders ^†	30/477 (6.29%)	5/239 (2.09%)
Palmar-plantar erythrodysesthesia syndrome ^†	55/477 (11.53%)	2/239 (0.84%)
Pruritus ^†	87/477 (18.24%)	28/239 (11.72%)
Rash acneiform ^†	283/477 (59.33%)	24/239 (10.04%)
Rash maculo-papular ^†	78/477 (16.35%)	16/239 (6.69%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

Despite the eligibility requirement for tumor samples, samples were not available or inadequate for translational studies in 30 - 40% of patients. This does limits the power of the secondary analyses examining biomarker driven outcomes.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Keyue Ding
Organization:	NCIC Clinical Trails Group
Phone:	1-613-533-6000 ext 77705
EMail:	kding@ctg.queensu.ca

Publications of Results:

Ellis PM, Shepherd FA, Millward M, Perrone F, Seymour L, Liu G, Sun S, Cho BC, Morabito A, Leighl NB, Stockler MR, Lee CW, Wierzbicki R, Cohen V, Blais N, Sangha RS, Favaretto AG, Kang JH, Tsao MS, Wilson CF, Goldberg Z, Ding K, Goss GD, Bradbury PA; NCIC CTG; Australasian Lung Cancer Trials Group; NCI Naples Clinical Trials Unit. Dacomitinib compared with placebo in pretreated patients with advanced or metastatic non-small-cell lung cancer (NCIC CTG BR.26): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2014 Nov;15(12):1379-88. doi: 10.1016/S1470-2045(14)70472-3. Epub 2014 Oct 15.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Martin P, Shiau CJ, Pasic M, Tsao M, Kamel-Reid S, Lin S, Tudor R, Cheng S, Higgins B, Burkes R, Ng M, Arif S, Ellis PM, Hubay S, Kuruvilla S, Laurie SA, Li J, Hwang D, Lau A, Shepherd FA, Le LW, Leighl NB. Clinical impact of mutation fraction in epidermal growth factor receptor mutation positive NSCLC patients. Br J Cancer. 2016 Mar 15;114(6):616-22. doi: 10.1038/bjc.2016.22. Epub 2016 Feb 18.

Layout table for additonal information

Responsible Party:	Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
ClinicalTrials.gov Identifier:	NCT01000025
Other Study ID Numbers:	BR26 CAN-NCIC-BR26 ( Other Identifier: PDQ ) PFIZER-CAN-NCIC-BR26 ( Other Identifier: Pfizer ) CDR0000657246 ( Other Identifier: PDQ )
First Submitted:	October 21, 2009
First Posted:	October 22, 2009
Results First Submitted:	September 19, 2014
Results First Posted:	October 27, 2014
Last Update Posted:	August 22, 2023

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