Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer (EVENT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01857271|
Recruitment Status : Terminated (low accrual)
First Posted : May 20, 2013
Results First Posted : July 8, 2020
Last Update Posted : July 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer||Drug: Erlotinib Hydrochloride Procedure: Therapeutic Conventional Surgery Other: Laboratory Biomarker Analysis||Phase 2|
I. To estimate the rate of mediastinal nodal clearance and complete pathological response after neoadjuvant erlotinib (erlotinib hydrochloride) in patients with epidermal growth factor receptor (EGFR) mutated stage III non-small cell lung cancer (NSCLC).
I. To determine the progression free survival in patient population of EGFR mutated stage III NSCLC patients who are treated with neoadjuvant erlotinib therapy.
II. To determine the overall survival. III. To estimate the overall response rate from neoadjuvant erlotinib. IV. To estimate the surgical resection rate. V. To evaluate the safety of neoadjuvant erlotinib.
I. To determine several molecular and cellular biomarkers in the tumors, the skin and the serum that are predictive of the efficacy of neoadjuvant erlotinib.
Patients receive erlotinib hydrochloride orally (PO) once daily (QD) for 2 months and then undergo thoracotomy.
After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, and then every 6 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III NSCLC Patients With EGFR Mutations (EVENT Trial)|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 31, 2017|
|Actual Study Completion Date :||August 31, 2017|
Experimental: Treatment (erlotinib hydrochloride and thoracotomy)
Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.
Drug: Erlotinib Hydrochloride
Other Name: Cp-358,774
Procedure: Therapeutic Conventional Surgery
Other: Laboratory Biomarker Analysis
- Rate of Mediastinal Nodal Clearance, Defined as Pathologically Negative N2 Disease in the Final Surgical Resection Specimen or Mediastinoscopy [ Time Frame: 3 years 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857271
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10461|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Haiying Cheng||Albert Einstein College of Medicine|