Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

This study has been completed.

Study NCT00085839 Information provided by OSI Pharmaceuticals

First Received on June 15, 2004. Last Updated on June 30, 2011 History of Changes

Results First Received: March 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Non-Small Cell Lung Cancer
Interventions:	Drug: Tarceva (Trademark) (erlotinib HCl, OSI-774) Drug: Combination carboplatin and 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
The first patient was treated 17 March 2004 and the last patient completed 19 March 2007.

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	Erlotinib 150 mg/day continuous therapy
Standard Chemotherapy	Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles

Participant Flow: Overall Study

	Erlotinib	Standard Chemotherapy
STARTED	52	51
COMPLETED	52	51
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Erlotinib	Erlotinib 150 mg/day continuous therapy
Standard Chemotherapy	Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles

Baseline Measures

	Erlotinib	Standard Chemotherapy	Total
Number of Participants [units: participants]	52	51	103
Age [units: years] Median ( Full Range )	69 ( 47 to 82 )	67 ( 47 to 84 )	68 ( 47 to 84 )
Gender [units: participants]
Female	29	23	52
Male	23	28	51
Race/Ethnicity, Customized [units: participants]
White	35	33	68
Black	12	10	22
Hispanic	4	7	11
Asian	1	1	2

Outcome Measures

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1. Primary:

Progression-free Survival [ Time Frame: Until time of disease progression (maximum 5 months) ]

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2. Secondary:

Overall Survival [ Time Frame: From first study treatment until time of death (maximum 26.8 months) ]

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3. Secondary:

Best Tumor Response [ Time Frame: While receiving study treatment (maximum 60 weeks) ]

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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.

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 Monitor
Organization: Astellas Pharma Global Development
e-mail: clinicaltrials@us.astellas.com

Publications of Results:

Lilenbaum R, Axelrod R, Thomas S, Dowlati A, Seigel L, Albert D, Witt K, Botkin D. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008 Feb 20;26(6):863-9.

Responsible Party:	Clinical Trials Registry, Astellas Pharma Global Development
ClinicalTrials.gov Identifier:	NCT00085839 History of Changes
Other Study ID Numbers:	OSI-774-201
Study First Received:	June 15, 2004
Results First Received:	March 28, 2011
Last Updated:	June 30, 2011
Health Authority:	United States: Food and Drug Administration