A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00457392

First received: April 4, 2007

Last updated: February 13, 2013

Last verified: February 2013

History of Changes

Results First Received: July 6, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Carcinoma, Non-Small Cell Lung
Interventions:	Drug: erlotinib Drug: sunitinib Drug: placebo

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
Sunitinib + Erlotinib	Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
Erlotinib	Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.

Participant Flow: Overall Study

	Sunitinib + Erlotinib	Erlotinib
STARTED	480	480
Treated	473	477
COMPLETED	0	0
NOT COMPLETED	480	480
Objective Progression or Relapse	221	288
Death	104	105
Adverse Event	82	40
Global Deterioration of Health Status	21	8
Withdrawal by Participant	14	9
Lost to Follow-up	5	6
Protocol Violation	4	3
Unspecified	7	1
Participants who are ongoing	15	17
Randomized, Not Treated	7	3

Baseline Characteristics

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Reporting Groups

	Description
Sunitinib + Erlotinib	Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
Erlotinib	Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
Total	Total of all reporting groups

Baseline Measures

	Sunitinib + Erlotinib	Erlotinib	Total
Number of Participants [units: participants]	480	480	960
Age [units: Years] Mean ± Standard Deviation	61.10 ± 9.97	60.80 ± 9.13	60.90 ± 9.56
Gender [units: Participants]
Female	183	196	379
Male	297	284	581

Outcome Measures

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1. Primary:

Overall Survival (OS) [ Time Frame: Baseline to death or 28 days after last dose for the last participant ]

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2. Secondary:

Progression-Free Survival (PFS) [ Time Frame: Baseline to disease progression or death due to any cause or 28 days after last dose ]

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3. Secondary:

Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline to disease progression or discontinuation from study or 28 days after last dose ]

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4. Secondary:

Duration of Response (DR) [ Time Frame: Baseline to disease progression or death or discontinuation from study or 28 days after last dose ]

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5. Secondary:

One-year Survival Probability [ Time Frame: Baseline until death or until 28 days after last dose for the last participant ]

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6. Secondary:

EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score [ Time Frame: Baseline and End of Treatment (EOT) or Withdrawal ]

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Serious Adverse Events

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Other Adverse Events

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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. Restriction Description: 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.

Limitations and Caveats

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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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00457392 History of Changes
Other Study ID Numbers:	A6181087, SUN1087
Study First Received:	April 4, 2007
Results First Received:	July 6, 2011
Last Updated:	February 13, 2013
Health Authority:	United States: Food and Drug Administration

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