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Erlotinib and Chemotherapy for Patients With Stage IB-IIIA NSCLC With EGFR Mutations (ECON)
This study has been completed.
Sponsor:
Memorial Sloan Kettering Cancer Center
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
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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 |
Show Baseline Characteristics
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. ] |
| 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:
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| 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:
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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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More Information
Certain Agreements:
Results Point of Contact:
| 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
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 |