Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)

This study has been completed.

Sponsor:

Collaborator:

Genentech, Inc.

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

ClinicalTrials.gov Identifier:

NCT00577707

First received: December 18, 2007

Last updated: October 19, 2015

Last verified: October 2015

History of Changes

Results First Received: October 19, 2015

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Non Small Cell Lung Cancer Lung Cancer
Intervention:	Drug: pemetrexed, cisplatin and erlotinib before surgery then erlotinib is given to patients after surgery for 2 years

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
Patients With Stage IB-IIIA NSCLC With EGFR Mutations	Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations

Participant Flow: Overall Study

	Patients With Stage IB-IIIA NSCLC With EGFR Mutations
STARTED	9
COMPLETED	6
NOT COMPLETED	3
Withdrawal by Subject	3

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
Patients With Stage IB-IIIA NSCLC With EGFR Mutations	Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations

Baseline Measures

	Patients With Stage IB-IIIA NSCLC With EGFR Mutations
Overall Participants Analyzed [Units: Participants]	9

Age [Units: Participants]
<=18 years	0
Between 18 and 65 years	4
>=65 years	5

Gender [Units: Participants]
Female	8
Male	1

Outcome Measures

1. Primary:

To Determine the Pathologic Complete Response Rate for Patients With Stage IB-IIIA NSCLC With Tumors That Harbor an EGFR Mutation Treated With Neoadjuvant Chemotherapy + Erlotinib [ Time Frame: Patients will undergo a CT scan of chest every 3 months for year 1 and every 4 months for year 2. In years 3 and 4, a chest CT or chest x-ray every 6 months. ]

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2. Secondary:

To Determine the Response Rate After 21 Days of Single Agent Erlotinib for Stage IB-IIIA NSCLC With a Known EGFR Mutation. [ Time Frame: calculate the response rate after 21 days of single agent erlotinib ]

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

3. Secondary:

To Determine the Response Rate, 3-year Overall Survival and Median Survival of Patients With Stage IB-IIIA NSCLC With a Known EGFR Mutation Receiving Neoadjuvant Chemotherapy and Erlotinib (and Adjuvant Erlotinib). [ Time Frame: 3 years ]

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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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Mark Kris
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4205
e-mail: krism@mskcc.org

Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00577707 History of Changes
Obsolete Identifiers:	NCT00602238
Other Study ID Numbers:	07-103
Study First Received:	December 18, 2007
Results First Received:	October 19, 2015
Last Updated:	October 19, 2015

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