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

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Hide Baseline Characteristics

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.
No text entered.

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. ]

Show Outcome Measure 1

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

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide 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
No text entered.

More Information

Show More Information

To Top