A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Genentech

ClinicalTrials.gov Identifier:

NCT00130728

First received: August 12, 2005

Last updated: September 26, 2011

Last verified: September 2011

History of Changes

Results First Received: November 16, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Non-Small Cell Lung Cancer
Interventions:	Drug: bevacizumab Drug: erlotinib HCl 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
Erlotinib HCl + Bevacizumab	oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo	oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Participant Flow: Overall Study

	Erlotinib HCl + Bevacizumab	Erlotinib HCl + Placebo
STARTED	319	317
Received Study Drug (Safety Population)	313	313
COMPLETED	108	104
NOT COMPLETED	211	213
Death	207	211
Lost to Follow-up	4	0
Withdrawal by Subject	0	2

Baseline Characteristics

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Reporting Groups

	Description
Erlotinib HCl + Bevacizumab	oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo	oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
Total	Total of all reporting groups

Baseline Measures

	Erlotinib HCl + Bevacizumab	Erlotinib HCl + Placebo	Total
Number of Participants [units: participants]	319	317	636
Age [units: years] Mean ± Standard Deviation	64.8 ± 10.4	65.0 ± 10.3	64.9 ± 10.4
Age, Customized [units: participants]
Between 18 and 59 years	91	90	181
Between 60 and 64 years	62	66	128
Between 65 and 69 years	59	53	112
>= 70 years	107	108	215
Gender [units: participants]
Female	148	147	295
Male	171	170	341

Outcome Measures

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1. Primary:

Overall Survival (OS) Among All Randomized Patients [ Time Frame: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years) ]

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2. Secondary:

Progression-free Survival (PFS) [ Time Frame: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years) ]

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3. Secondary:

Percentage of Participants With Objective Response [ Time Frame: The median duration of Objective response was up to 9.7 months ]

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Measure Type	Secondary
Measure Title	Percentage of Participants With Objective Response
Measure Description	Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions >= 4 weeks apart.
Time Frame	The median duration of Objective response was up to 9.7 months
Safety Issue	No

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.
Only patients with measurable disease at baseline were included in the analysis of the objective response. Patients without a post-baseline tumor assessment were considered non-responder.

Reporting Groups

	Description
Erlotinib HCl + Bevacizumab	oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
Erlotinib HCl + Placebo	oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle

Measured Values

	Erlotinib HCl + Bevacizumab	Erlotinib HCl + Placebo
Number of Participants Analyzed [units: participants]	301	306
Percentage of Participants With Objective Response [units: Percentage of participants] Number ( 95% Confidence Interval )	12.6 ( 9.1 to 16.8 )	6.2 ( 3.8 to 9.5 )

Statistical Analysis 1 for Percentage of Participants With Objective Response

Groups ^[1]	All groups
Method ^[2]	Mantel Haenszel
P Value ^[3]	0.0068
Percentage difference ^[4]	6.4
95% Confidence Interval	( 1.8 to 11.3 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Relative to placebo arm
[4]	Other relevant estimation information:
	Difference in objective response rates relative to placebo arm

4. Secondary:

Duration of Objective Response [ Time Frame: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months) ]

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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: The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study.

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: Medical Communications Specialist
Organization: Genentech, Inc.
phone: 800-821-8590

No publications provided by Genentech

Publications automatically indexed to this study:

Herbst RS, Ansari R, Bustin F, Flynn P, Hart L, Otterson GA, Vlahovic G, Soh CH, O'Connor P, Hainsworth J. Efficacy of bevacizumab plus erlotinib versus erlotinib alone in advanced non-small-cell lung cancer after failure of standard first-line chemotherapy (BeTa): a double-blind, placebo-controlled, phase 3 trial. Lancet. 2011 May 28;377(9780):1846-54.

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT00130728 History of Changes
Other Study ID Numbers:	OSI3364g
Study First Received:	August 12, 2005
Results First Received:	November 16, 2009
Last Updated:	September 26, 2011
Health Authority:	United States: Food and Drug Administration

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