Sunitinib Malate as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Treated With Combination Chemotherapy

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ClinicalTrials.gov Identifier: NCT00693992

Recruitment Status : Completed

First Posted : June 9, 2008

Results First Posted : February 2, 2017

Last Update Posted : June 11, 2019

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Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Conditions	Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7
Interventions	Other: Laboratory Biomarker Analysis Other: Placebo Other: Quality-of-Life Assessment Drug: Sunitinib Malate
Enrollment	210

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm I (Sunitinib Malate)	Arm II (Placebo)
Arm/Group Description	Patients receive sunitinib malate 3...	Patients receive placebo 37.5 mg PO...
Arm/Group Description	Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO	Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
Period Title: Overall Study
Started	106	104
Completed	106	104
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Arm I (Sunitinib Malate)	Arm II (Placebo)	Total
Arm/Group Description		Patients receive sunitinib malate 3...	Patients receive placebo 37.5 mg PO...	Total of all reporting groups
Arm/Group Description		Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO	Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies	Total of all reporting groups
Overall Number of Baseline Participants		106	104	210
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Median (Full Range) Unit of measure: Years
	Number Analyzed	106 participants	104 participants	210 participants
		65 (25 to 84)	67 (44 to 89)	66 (25 to 89)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	106 participants	104 participants	210 participants
	Female	49 46.2%	44 42.3%	93 44.3%
	Male	57 53.8%	60 57.7%	117 55.7%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	106 participants	104 participants	210 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	3 2.9%	3 1.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	18 17.0%	13 12.5%	31 14.8%
	White	87 82.1%	85 81.7%	172 81.9%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 0.9%	3 2.9%	4 1.9%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	106 participants	104 participants	210 participants
United States		106	104	210

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival (PFS)
Description	Progression Free Survival (PFS) was defined as the time from randomiza...
Description	Progression Free Survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.
Time Frame	Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm I (Sunitinib Malate)	Arm II (Placebo)
Arm/Group Description:	Patients receive sunitinib malate 3...	Patients receive placebo 37.5 mg PO...
Arm/Group Description:	Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO	Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	106	104
Median (95% Confidence Interval) Unit of Measure: months
	4.3 (3.2 to 4.9)	2.6 (1.8 to 3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Sunitinib Malate), Arm II (Placebo)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0006
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.62
	Confidence Interval	(2-Sided) 95% 0.47 to 0.82
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival (OS)
Description	Overall survival (OS) is defined as the time from patient randomizatio...
Description	Overall survival (OS) is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.
Time Frame	Time from randomization to death (up to 5 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm I (Sunitinib Malate)	Arm II (Placebo)
Arm/Group Description:	Patients receive sunitinib malate 3...	Patients receive placebo 37.5 mg PO...
Arm/Group Description:	Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO	Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	106	104
Median (95% Confidence Interval) Unit of Measure: months
	11.7 (9.9 to 14.0)	12.1 (9.8 to 15.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Sunitinib Malate), Arm II (Placebo)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.89
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95% 0.73 to 1.31
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	Response Rate (RR)
Description	The percentage of patients who respond (completely or partially) to ea...
Description	The percentage of patients who respond (completely or partially) to each combination regimen will be estimated. Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.
Time Frame	Duration of treatment (up to 5 years)

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm I (Sunitinib Malate)	Arm II (Placebo)
Arm/Group Description:	Patients receive sunitinib malate 3...	Patients receive placebo 37.5 mg PO...
Arm/Group Description:	Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO	Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	106	104
Measure Type: Number Unit of Measure: percentage of participants
	11	5

4.Secondary Outcome


Title	Percentage of Deterioration in QOL at 3 Months Using the EORTC QLQ-C30 Global Health Subscale
Description	The percentage of patients with at least a 10% drop in the EORTC-QLQ-C...
Description	The percentage of patients with at least a 10% drop in the EORTC-QLQ-C30 Global Health Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
Time Frame	At 3 months

Outcome Measure Data

Analysis Population Description

Patients who completed the EORTC-QLQ-C30 Global Health Subscale at baseline and 3 months were included in this analysis.


Arm/Group Title	Arm I (Sunitinib Malate)	Arm II (Placebo)
Arm/Group Description:	Patients receive sunitinib malate 3...	Patients receive placebo 37.5 mg PO...
Arm/Group Description:	Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO	Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	80	83
Measure Type: Number Unit of Measure: percentage of patients
	55.8	28.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Sunitinib Malate), Arm II (Placebo)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0061
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

5.Secondary Outcome


Title	Percentage of Deterioration in Symptom Progression at 3 Months Using the EORTC LC13 Dyspnea Subscale
Description	The percentage of patients with at least a 10% drop in the EORTC LC13 ...
Description	The percentage of patients with at least a 10% drop in the EORTC LC13 Dyspnea Subscale score from baseline to 3-months. The difference between groups will be tested using Fisher's exact test.
Time Frame	At 3 months

Outcome Measure Data

Analysis Population Description

Patients who completed the EORTC LC13 Dyspnea Subscale at baseline and 3 months were included in this analysis.


Arm/Group Title	Arm I (Sunitinib Malate)	Arm II (Placebo)
Arm/Group Description:	Patients receive sunitinib malate 3...	Patients receive placebo 37.5 mg PO...
Arm/Group Description:	Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO	Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	83	85
Measure Type: Number Unit of Measure: percentage of patients
	31.5	29.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Sunitinib Malate), Arm II (Placebo)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.8393
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]

6.Secondary Outcome


Title	Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Description	Grade 3 or 4 adverse events which affected more than 5% of participant...
Description	Grade 3 or 4 adverse events which affected more than 5% of participants are summarized by arm.
Time Frame	Duration of study (up to 5 years)

Outcome Measure Data

Analysis Population Description

189 participants were evaluable for adverse events.


Arm/Group Title	Arm I (Sunitinib Malate)	Arm II (Placebo)
Arm/Group Description:	Patients receive sunitinib malate 3...	Patients receive placebo 37.5 mg PO...
Arm/Group Description:	Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO	Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed	97	92
Measure Type: Number Unit of Measure: percentage of participants
Fatigue	26	0
Thrombocytopenia	12	0
Hypertension	12	0
Rash	11	0
Mucositis	11	0
Neutropenia	7	0
Anemia	6	0

7.Other Pre-specified Outcome


Title	VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 6 weeks

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	189 participants were evaluable for adverse events.

Arm/Group Title	Arm I (Sunitinib Malate)		Arm II (Placebo)
Arm/Group Description	Patients receive sunitinib malate 3...		Patients receive placebo 37.5 mg PO...
Arm/Group Description	Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Sunitinib Malate: Given PO		Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Placebo: Given PO Quality-of-Life Assessment: Ancillary studies
All-Cause Mortality
	Arm I (Sunitinib Malate)		Arm II (Placebo)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Arm I (Sunitinib Malate)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	33/97 (34.02%)		14/92 (15.22%)
Blood and lymphatic system disorders
Hemoglobin decreased ^† 1	10/97 (10.31%)	11	1/92 (1.09%)	1
Hemolysis ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Cardiac disorders
Cardiac disorder ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Conduction disorder ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Left ventricular failure ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Myocardial ischemia ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Palpitations ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Ear and labyrinth disorders
External ear inflammation ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Endocrine disorders
Hypothyroidism ^† 1	2/97 (2.06%)	3	0/92 (0.00%)	0
Gastrointestinal disorders
Abdominal pain ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Constipation ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Diarrhea ^† 1	5/97 (5.15%)	6	1/92 (1.09%)	1
Duodenal hemorrhage ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Dyspepsia ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Dysphagia ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Gastrointestinal disorder ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Mucositis oral ^† 1	5/97 (5.15%)	5	0/92 (0.00%)	0
Nausea ^† 1	9/97 (9.28%)	10	5/92 (5.43%)	5
Oral hemorrhage ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Pancreatitis ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Upper gastrointestinal hemorrhage ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Vomiting ^† 1	4/97 (4.12%)	4	1/92 (1.09%)	1
General disorders
Chest pain ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Fatigue ^† 1	26/97 (26.80%)	34	8/92 (8.70%)	9
Fever ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Localized edema ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Pain ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Sudden death ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Hepatobiliary disorders
Cholecystitis ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Immune system disorders
Immune system disorder ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Infections and infestations
Infection without neutropenia ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Pneumonia ^† 1	3/97 (3.09%)	3	0/92 (0.00%)	0
Sepsis ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Skin infection ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Urinary tract infection ^† 1	3/97 (3.09%)	3	0/92 (0.00%)	0
Injury, poisoning and procedural complications
Fracture ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Investigations
Alanine aminotransferase increased ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Alkaline phosphatase increased ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Amylase increased ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Aspartate aminotransferase increased ^† 1	4/97 (4.12%)	4	0/92 (0.00%)	0
Electrocardiogram QTc interval prolonged ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Leukocyte count decreased ^† 1	3/97 (3.09%)	4	1/92 (1.09%)	1
Lipase increased ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Lymphocyte count decreased ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Neutrophil count decreased ^† 1	4/97 (4.12%)	4	0/92 (0.00%)	0
Platelet count decreased ^† 1	9/97 (9.28%)	11	0/92 (0.00%)	0
Metabolism and nutrition disorders
Anorexia ^† 1	12/97 (12.37%)	13	2/92 (2.17%)	3
Blood glucose increased ^† 1	1/97 (1.03%)	1	2/92 (2.17%)	2
Dehydration ^† 1	4/97 (4.12%)	4	0/92 (0.00%)	0
Serum albumin decreased ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Serum calcium decreased ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Serum magnesium decreased ^† 1	1/97 (1.03%)	1	1/92 (1.09%)	1
Serum phosphate decreased ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Serum potassium increased ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Serum sodium decreased ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Serum sodium increased ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Musculoskeletal and connective tissue disorders
Back pain ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Bone pain ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Chest wall pain ^† 1	1/97 (1.03%)	1	1/92 (1.09%)	1
Muscle weakness ^† 1	3/97 (3.09%)	3	1/92 (1.09%)	1
Neck pain ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Pain in extremity ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Nervous system disorders
Cognitive disturbance ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Depressed level of consciousness ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Dizziness ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Dysgeusia ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Encephalopathy ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Headache ^† 1	1/97 (1.03%)	2	0/92 (0.00%)	0
Ischemia cerebrovascular ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Peripheral motor neuropathy ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Peripheral sensory neuropathy ^† 1	3/97 (3.09%)	3	0/92 (0.00%)	0
Syncope ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Psychiatric disorders
Confusion ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Depression ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Insomnia ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Renal and urinary disorders
Proteinuria ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Renal failure ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Atelectasis ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Bronchial obstruction ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Cough ^† 1	3/97 (3.09%)	3	2/92 (2.17%)	2
Dyspnea ^† 1	7/97 (7.22%)	7	5/92 (5.43%)	5
Epistaxis ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Hypoxia ^† 1	3/97 (3.09%)	3	2/92 (2.17%)	2
Pleural effusion ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Pulmonary hemorrhage ^† 1	1/97 (1.03%)	1	1/92 (1.09%)	1
Respiratory disorder ^† 1	1/97 (1.03%)	1	1/92 (1.09%)	1
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome ^† 1	6/97 (6.19%)	8	0/92 (0.00%)	0
Skin hypopigmentation ^† 1	2/97 (2.06%)	3	0/92 (0.00%)	0
Vascular disorders
Hypertension ^† 1	7/97 (7.22%)	8	3/92 (3.26%)	3
Thrombosis ^† 1	1/97 (1.03%)	1	1/92 (1.09%)	2
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 6
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm I (Sunitinib Malate)		Arm II (Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	87/97 (89.69%)		85/92 (92.39%)
Blood and lymphatic system disorders
Hemoglobin decreased ^† 1	9/97 (9.28%)	28	3/92 (3.26%)	6
Hemolysis ^† 1	0/97 (0.00%)	0	2/92 (2.17%)	9
Cardiac disorders
Left ventricular failure ^† 1	1/97 (1.03%)	1	2/92 (2.17%)	4
Sinus bradycardia ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Ventricular tachycardia ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Ear and labyrinth disorders
External ear inflammation ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Endocrine disorders
Hypothyroidism ^† 1	5/97 (5.15%)	11	5/92 (5.43%)	7
Gastrointestinal disorders
Abdominal pain ^† 1	2/97 (2.06%)	2	2/92 (2.17%)	3
Constipation ^† 1	0/97 (0.00%)	0	2/92 (2.17%)	3
Diarrhea ^† 1	44/97 (45.36%)	112	15/92 (16.30%)	37
Dyspepsia ^† 1	1/97 (1.03%)	2	0/92 (0.00%)	0
Dysphagia ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Flatulence ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Gastritis ^† 1	1/97 (1.03%)	2	0/92 (0.00%)	0
Mouth necrosis ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Mucositis oral ^† 1	34/97 (35.05%)	71	7/92 (7.61%)	14
Nausea ^† 1	37/97 (38.14%)	73	20/92 (21.74%)	42
Stomach pain ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Vomiting ^† 1	5/97 (5.15%)	10	1/92 (1.09%)	1
General disorders
Chest pain ^† 1	3/97 (3.09%)	4	0/92 (0.00%)	0
Edema limbs ^† 1	0/97 (0.00%)	0	4/92 (4.35%)	13
Fatigue ^† 1	69/97 (71.13%)	218	67/92 (72.83%)	204
Fever ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Localized edema ^† 1	1/97 (1.03%)	3	0/92 (0.00%)	0
Pain ^† 1	2/97 (2.06%)	2	1/92 (1.09%)	1
Immune system disorders
Immune system disorder ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Infections and infestations
Pneumonia ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Injury, poisoning and procedural complications
Bruising ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Fracture ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Injury to superior vena cava ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Investigations
Alanine aminotransferase increased ^† 1	1/97 (1.03%)	2	1/92 (1.09%)	1
Alkaline phosphatase increased ^† 1	2/97 (2.06%)	3	0/92 (0.00%)	0
Amylase increased ^† 1	1/97 (1.03%)	1	2/92 (2.17%)	4
Aspartate aminotransferase increased ^† 1	1/97 (1.03%)	2	1/92 (1.09%)	1
CD4 lymphocytes decreased ^† 1	2/97 (2.06%)	3	0/92 (0.00%)	0
Creatinine increased ^† 1	1/97 (1.03%)	12	3/92 (3.26%)	15
Electrocardiogram QTc interval prolonged ^† 1	1/97 (1.03%)	1	2/92 (2.17%)	4
Leukocyte count decreased ^† 1	7/97 (7.22%)	23	2/92 (2.17%)	9
Lipase increased ^† 1	1/97 (1.03%)	1	2/92 (2.17%)	4
Lymphocyte count decreased ^† 1	3/97 (3.09%)	6	0/92 (0.00%)	0
Neutrophil count decreased ^† 1	10/97 (10.31%)	23	1/92 (1.09%)	1
Platelet count decreased ^† 1	13/97 (13.40%)	24	1/92 (1.09%)	2
Weight loss ^† 1	4/97 (4.12%)	6	0/92 (0.00%)	0
Metabolism and nutrition disorders
Anorexia ^† 1	32/97 (32.99%)	83	19/92 (20.65%)	34
Blood glucose increased ^† 1	1/97 (1.03%)	2	7/92 (7.61%)	31
Blood uric acid increased ^† 1	1/97 (1.03%)	12	0/92 (0.00%)	0
Serum albumin decreased ^† 1	3/97 (3.09%)	7	0/92 (0.00%)	0
Serum calcium increased ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	3
Serum glucose decreased ^† 1	0/97 (0.00%)	0	2/92 (2.17%)	2
Serum magnesium decreased ^† 1	1/97 (1.03%)	2	2/92 (2.17%)	7
Serum phosphate decreased ^† 1	1/97 (1.03%)	1	1/92 (1.09%)	6
Serum potassium decreased ^† 1	2/97 (2.06%)	3	1/92 (1.09%)	7
Serum sodium decreased ^† 1	4/97 (4.12%)	8	1/92 (1.09%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	2/97 (2.06%)	2	1/92 (1.09%)	3
Back pain ^† 1	3/97 (3.09%)	5	6/92 (6.52%)	12
Bone pain ^† 1	1/97 (1.03%)	1	1/92 (1.09%)	1
Chest wall pain ^† 1	1/97 (1.03%)	3	1/92 (1.09%)	1
Muscle weakness ^† 1	1/97 (1.03%)	3	0/92 (0.00%)	0
Musculoskeletal disorder ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Myalgia ^† 1	1/97 (1.03%)	1	2/92 (2.17%)	3
Neck pain ^† 1	1/97 (1.03%)	4	0/92 (0.00%)	0
Pain in extremity ^† 1	3/97 (3.09%)	3	2/92 (2.17%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
Nervous system disorders
Accessory nerve disorder ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Depressed level of consciousness ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Dizziness ^† 1	0/97 (0.00%)	0	2/92 (2.17%)	2
Dysgeusia ^† 1	4/97 (4.12%)	8	1/92 (1.09%)	1
Headache ^† 1	15/97 (15.46%)	27	12/92 (13.04%)	26
Ischemia cerebrovascular ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Peripheral motor neuropathy ^† 1	1/97 (1.03%)	1	1/92 (1.09%)	2
Peripheral sensory neuropathy ^† 1	6/97 (6.19%)	15	5/92 (5.43%)	7
Syncope ^† 1	1/97 (1.03%)	1	1/92 (1.09%)	1
Psychiatric disorders
Agitation ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	6
Anxiety ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Confusion ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Depression ^† 1	1/97 (1.03%)	2	1/92 (1.09%)	1
Insomnia ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Renal and urinary disorders
Renal failure ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	5/97 (5.15%)	7	5/92 (5.43%)	13
Dyspnea ^† 1	5/97 (5.15%)	7	6/92 (6.52%)	23
Epistaxis ^† 1	4/97 (4.12%)	6	0/92 (0.00%)	0
Mediastinal hemorrhage ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Pharyngolaryngeal pain ^† 1	1/97 (1.03%)	1	0/92 (0.00%)	0
Pulmonary hemorrhage ^† 1	1/97 (1.03%)	2	2/92 (2.17%)	2
Respiratory tract hemorrhage ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	3
Skin and subcutaneous tissue disorders
Alopecia ^† 1	1/97 (1.03%)	1	3/92 (3.26%)	4
Hand-and-foot syndrome ^† 1	28/97 (28.87%)	83	8/92 (8.70%)	14
Rash desquamating ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	2
Skin hypopigmentation ^† 1	9/97 (9.28%)	21	0/92 (0.00%)	0
Vascular disorders
Hemorrhage ^† 1	2/97 (2.06%)	2	0/92 (0.00%)	0
Hypertension ^† 1	29/97 (29.90%)	81	13/92 (14.13%)	41
Thrombosis ^† 1	0/97 (0.00%)	0	1/92 (1.09%)	1
† Indicates events were collected by systematic assessment 1 Term from vocabulary, MedDRA 6

Limitations and Caveats

[Not Specified]

More Information

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.

Results Point of Contact

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Name/Title:	Mark A. Socinski, M.D.
Organization:	University of Pittsburgh
EMail:	socinskima@upmc.edu

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

Baggstrom MQ, Socinski MA, Wang XF, Gu L, Stinchcombe TE, Edelman MJ, Baker S Jr, Feliciano J, Novotny P, Hahn O, Crawford JA, Vokes EE. Maintenance Sunitinib following Initial Platinum-Based Combination Chemotherapy in Advanced-Stage IIIB/IV Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Placebo-Controlled Phase III Study-CALGB 30607 (Alliance). J Thorac Oncol. 2017 May;12(5):843-849. doi: 10.1016/j.jtho.2017.01.022. Epub 2017 Feb 1.

Layout table for additonal information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00693992
Obsolete Identifiers:	NCT01647087
Other Study ID Numbers:	NCI-2009-00469 NCI-2009-00469 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000597649 CALGB 30607 ( Other Identifier: Alliance for Clinical Trials in Oncology ) CALGB-30607 ( Other Identifier: CTEP ) U10CA180821 ( U.S. NIH Grant/Contract ) U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted:	June 6, 2008
First Posted:	June 9, 2008
Results First Submitted:	December 8, 2016
Results First Posted:	February 2, 2017
Last Update Posted:	June 11, 2019

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