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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Haiying Cheng, Albert Einstein College of Medicine

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stage IIIA Non-Small Cell Lung Cancer
Stage IIIB Non-Small Cell Lung Cancer
Interventions Drug: Erlotinib Hydrochloride
Procedure: Therapeutic Conventional Surgery
Other: Laboratory Biomarker Analysis
Enrollment 3
Recruitment Details The patients were enrolled on 11/7/2013, 5/2014, and 9/24/2014.
Pre-assignment Details The study was difficult to enroll and eventually terminated/closed.
Arm/Group Title Treatment (Erlotinib Hydrochloride)
Hide Arm/Group Description

Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo restaging procedures to evaluate for surgery.

Erlotinib Hydrochloride: Given PO

Laboratory Biomarker Analysis: Correlative studies

Period Title: Overall Study
Started 3
Completed 2
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Treatment (Erlotinib Hydrochloride and Thoracotomy)
Hide Arm/Group Description

Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.

Erlotinib Hydrochloride: Given PO

Therapeutic Conventional Surgery: Undergo thoracotomy

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
[1]
Measure Description: Two females, one male.
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
1
  33.3%
Not Hispanic or Latino
1
  33.3%
Unknown or Not Reported
1
  33.3%
1.Primary Outcome
Title Rate of Mediastinal Nodal Clearance, Defined as Pathologically Negative N2 Disease in the Final Surgical Resection Specimen or Mediastinoscopy
Hide Description [Not Specified]
Time Frame 3 years 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closely prematurely due to poor accrual. No final analysis was performed due to very low number of subjects.
Arm/Group Title Treatment (Erlotinib Hydrochloride and Thoracotomy)
Hide Arm/Group Description:

Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.

Erlotinib Hydrochloride: Given PO

Therapeutic Conventional Surgery: Undergo thoracotomy

Laboratory Biomarker Analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Erlotinib Hydrochloride and Thoracotomy)
Hide Arm/Group Description

Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.

Erlotinib Hydrochloride: Given PO

Therapeutic Conventional Surgery: Undergo thoracotomy

Laboratory Biomarker Analysis: Correlative studies

All-Cause Mortality
Treatment (Erlotinib Hydrochloride and Thoracotomy)
Affected / at Risk (%)
Total   1/3 (33.33%) 
Hide Serious Adverse Events
Treatment (Erlotinib Hydrochloride and Thoracotomy)
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Erlotinib Hydrochloride and Thoracotomy)
Affected / at Risk (%)
Total   1/3 (33.33%) 
Gastrointestinal disorders   
Diarrhea   1/3 (33.33%) 
Skin and subcutaneous tissue disorders   
Rash   1/3 (33.33%) 
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Haiying Cheng
Organization: Albert Einstein Cancer Center
Phone: 718-405-8404
EMail: hcheng@montefiore.org
Layout table for additonal information
Responsible Party: Haiying Cheng, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT01857271    
Other Study ID Numbers: 2013-233
NCI-2013-02219 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2013-233-004
2013-233 ( Other Identifier: Albert Einstein College of Medicine )
P30CA013330 ( U.S. NIH Grant/Contract )
First Submitted: May 16, 2013
First Posted: May 20, 2013
Results First Submitted: November 15, 2019
Results First Posted: July 8, 2020
Last Update Posted: July 8, 2020