Study Stopped
low accrual
Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer
EVENT
EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III NSCLC Patients With EGFR Mutations (EVENT Trial)
4 other identifiers
interventional
3
1 country
3
Brief Summary
This phase II trial studies how well erlotinib hydrochloride works before surgery in treating patients with stage III non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib hydrochloride before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2013
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedResults Posted
Study results publicly available
July 8, 2020
CompletedJuly 8, 2020
June 1, 2020
3.8 years
May 16, 2013
November 15, 2019
June 24, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Mediastinal Nodal Clearance, Defined as Pathologically Negative N2 Disease in the Final Surgical Resection Specimen or Mediastinoscopy
3 years 9 months
Study Arms (1)
Treatment (erlotinib hydrochloride and thoracotomy)
EXPERIMENTALPatients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.
Interventions
Given PO
Undergo thoracotomy
Correlative studies
Eligibility Criteria
You may qualify if:
- Pathologically proven (either histologic or cytologic) diagnosis of stage IIIA or IIIB non-small cell lung cancer; (according to American Joint Committee on Cancer \[AJCC\] staging, 7th edition) within 4 weeks of registration; the patient should have histologically or cytologically confirmed N2 disease
- Activating mutation in EGFR
- No prior chemotherapy or radiation for lung cancer
- Patients may be potentially resectable or unresectable
- Stage III A or B disease, including no distant metastases- based on following diagnostic workup:
- History/physical examination prior to registration
- Computed tomography (CT) scan of the chest or positron emission tomography (PET) scan within 28 days of study entry
- CT scan of abdomen or magnetic resonance imaging (MRI) of abdomen or PET scan within 28 days of study entry
- An MRI of the brain or head CT scan with contrast within 28 days of study entry
- Total body PET scan within 28 days of study entry
- Mediastinoscopies are highly recommended
- Patients must have measurable or evaluable disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) \>= 1,500 cells/ul
- Platelets \>= 100,000 cells/ul
- +9 more criteria
You may not qualify if:
- Pleural or pericardial effusion
- Pleural effusions allowed if one of the following conditions are met: 1) negative cytology after adequate sampling by thoracentesis 2) effusion seen on CT scan but not on chest x-ray and deemed too small to tap under CT or ultrasound guidance
- Severe, active co-morbidity, defined as follows:
- Uncontrolled angina, congestive heart failure or myocardial infarction (MI) within (6 months)
- Diagnosed congenital long QT syndrome
- Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
- Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 450 msec)
- History of significant bleeding disorder unrelated to cancer, including:
- Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
- Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
- Ongoing or recent (=\< 3 months) significant gastrointestinal bleeding
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
- Men and women who:
- Are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or women who:
- Have a positive pregnancy test at baseline, or
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Columbia University Medical Center
New York, New York, 10032, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Haiying Cheng
- Organization
- Albert Einstein Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Haiying Cheng
Albert Einstein College of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 16, 2013
First Posted
May 20, 2013
Study Start
November 1, 2013
Primary Completion
August 31, 2017
Study Completion
August 31, 2017
Last Updated
July 8, 2020
Results First Posted
July 8, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share