A Study of Bevacizumab Plus Carboplatin and Paclitaxel in Subjects With Advanced, Previously Untreated, Squamous Non-Small Cell Lung Cancer (BRIDGE)

This study has been completed.

Sponsor:

Information provided by:

Genentech

ClinicalTrials.gov Identifier:

NCT00318136

First received: April 24, 2006

Last updated: May 5, 2010

Last verified: May 2010

History of Changes

Results First Received: March 19, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Non-small Cell Lung Cancer
Interventions:	Drug: Bevacizumab Drug: Carboplatin Drug: Paclitaxel

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
Treated With Bevacizumab	Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).

Participant Flow: Overall Study

	Treated With Bevacizumab
STARTED	47
COMPLETED	2
NOT COMPLETED	45

Baseline Characteristics

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Reporting Groups

	Description
Treated With Bevacizumab	Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).

Baseline Measures

	Treated With Bevacizumab
Number of Participants [units: participants]	31
Age ^[1] [units: years] Mean ± Standard Deviation	65.0 ± 7.9
Gender ^[1] [units: participants]
Female	10
Male	21

[1]	Of the 47 enrolled subjects, 31 met the protocol-specified criteria and received bevacizumab.

Outcome Measures

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1. Primary:

Incidence of Grade ≥3 Pulmonary Hemorrhage Adverse Events [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ]

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2. Secondary:

Selected Adverse Events [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ]

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3. Secondary:

Adverse Events That Led to Discontinuation of Bevacizumab [ Time Frame: First bevacizumab administration until 60 days after discontinuation of bevacizumab or death ]

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4. Secondary:

Progression-free Survival [ Time Frame: Length of study ]

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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. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.

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
Organization: Genentech, Inc.
phone: 800-821-8590

No publications provided

Responsible Party:	Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier:	NCT00318136 History of Changes
Other Study ID Numbers:	AVF3744g
Study First Received:	April 24, 2006
Results First Received:	March 19, 2010
Last Updated:	May 5, 2010
Health Authority:	United States: Food and Drug Administration

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