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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00693992

First received: June 6, 2008

Last updated: December 8, 2016

Last verified: December 2016

History of Changes

Results First Received: December 8, 2016

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

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Arm I (Sunitinib Malate)	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
Arm II (Placebo)	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

Description

Arm I (Sunitinib Malate)

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

Arm II (Placebo)

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

Participant Flow: Overall Study

	Arm I (Sunitinib Malate)	Arm II (Placebo)
STARTED	106	104
COMPLETED	106	104
NOT COMPLETED	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Arm I (Sunitinib Malate)	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
Arm II (Placebo)	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	Total of all reporting groups

Description

Arm I (Sunitinib Malate)

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

Arm II (Placebo)

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

Total of all reporting groups

Baseline Measures

	Arm I (Sunitinib Malate)	Arm II (Placebo)	Total
Overall Participants Analyzed [Units: Participants]	106	104	210

Age [Units: Years] Median (Full Range)	65 (25 to 84)	67 (44 to 89)	66 (25 to 89)

Gender [Units: Participants] Count of Participants
Female	49 46.2%	44 42.3%	93 44.3%
Male	57 53.8%	60 57.7%	117 55.7%

Race (NIH/OMB) [Units: Participants] Count of 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 [Units: Participants]
United States	106	104	210

Outcome Measures

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1. Primary:

PFS [ Time Frame: Time from randomization to disease progression and death of any cause, whichever comes first (up to 5 years) ]

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2. Secondary:

Overall Survival (OS) [ Time Frame: Time from randomization to death (up to 5 years) ]

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3. Secondary:

Response Rate (RR) [ Time Frame: Duration of treatment (up to 5 years) ]

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4. Secondary:

Grade and Type of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Duration of study (up to 5 years) ]

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5. Secondary:

Time to Deterioration in QOL and Symptom Progression Using the EORTC QLQ-C30 and LC13 [ Time Frame: Up to 5 years ]

Results not yet reported. Anticipated Reporting Date: No text entered.

6. Secondary:

Time to Quality of Life or Symptom Deterioration as Assessed by Continuous Quality of Life (QOL) Scores, Including QLQ-C30 and LC13 Subscales [ Time Frame: Up to 5 years ]

Results not yet reported. Anticipated Reporting Date: No text entered.

7. Secondary:

VEGF Levels and Correlation With Clinical Outcomes, Including RR, PFS, and OS [ Time Frame: Up to 6 weeks ]

Results not yet reported. Anticipated Reporting Date: No text entered.

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:

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

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00693992 History of Changes
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 ( US NIH Grant/Contract Award Number ) U10CA031946 ( US NIH Grant/Contract Award Number )
Study First Received:	June 6, 2008
Results First Received:	December 8, 2016
Last Updated:	December 8, 2016

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