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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

Tracking Information
First Submitted Date  ICMJE May 16, 2013
First Posted Date  ICMJE May 20, 2013
Results First Submitted Date  ICMJE November 15, 2019
Results First Posted Date  ICMJE July 8, 2020
Last Update Posted Date July 8, 2020
Study Start Date  ICMJE November 2013
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2020)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
Rate of mediastinal nodal clearance and complete pathological response after neoadjuvant erlotinib. [ Time Frame: 2 months ]
The mediastinal nodal clearance is defined as pathologicaly negative N2 disease in the final surgical resection specimen or mediastinoscopy. This can be objectively measured and in the literature, has been confirmed as the best predictor of long term survival in patients with stage III NSCLC treated with neoadjuvant therapy and had surgical resection.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2013)
  • Progression Free Survival [ Time Frame: 5 years ]
    Length of time during and after study enrollment which cancer does not get worse radiologically. Evaluations will be performed every 3 months for first year, every 6 months afterward.
  • Overall Survival [ Time Frame: 5 years ]
    Length of time from study enrollment until death. Follow-ups will be performed every 3 months for first year, every 6 months afterward.
  • Number and Nature of Adverse Events experienced [ Time Frame: Up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 16, 2013)
  • Overall response rate from neoadjuvant erlotinib [ Time Frame: 2 months ]
  • Surgical resection rate [ Time Frame: 2 months ]
  • Determination of predictive value of molecular and cellular biomarkers. [ Time Frame: Up to 5 years ]
    Several molecular and cellular biomarkers in the tumors, skin and serum that are potentially predictive of the efficacy of neoadjuvant Tarceva (erlotinib) will be investigated as correlative studies.
 
Descriptive Information
Brief Title  ICMJE Erlotinib Hydrochloride Before Surgery in Treating Patients With Stage III Non-Small Cell Lung Cancer
Official Title  ICMJE EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III NSCLC Patients With EGFR Mutations (EVENT Trial)
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.
Detailed Description

PRIMARY OBJECTIVES:

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).

SECONDARY OBJECTIVES:

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.

TERTIARY OBJECTIVES:

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.

OUTLINE:

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stage IIIA Non-Small Cell Lung Cancer
  • Stage IIIB Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Erlotinib Hydrochloride
    Given PO
    Other Name: Cp-358,774
  • Procedure: Therapeutic Conventional Surgery
    Undergo thoracotomy
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Study Arms  ICMJE Experimental: Treatment (erlotinib hydrochloride and thoracotomy)
Patients receive erlotinib hydrochloride PO QD for 2 months and then undergo thoracotomy.
Interventions:
  • Drug: Erlotinib Hydrochloride
  • Procedure: Therapeutic Conventional Surgery
  • Other: Laboratory Biomarker Analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 27, 2018)
3
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2013)
55
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • Hemoglobin >= 9.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= g/dl is acceptable)
  • Serum creatinine =< 1.5 x upper limit of normal (ULN)
  • Total bilirubin < 2.0 times the institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x the ULN
  • Women of childbearing potential must have:

    • A negative serum or urine pregnancy test (sensitivity =< 25 IU human chorionic gonadotropin [HCG]/L) within 72 hours prior to the start of study drug administration
    • Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy
  • Ability to take oral medication
  • Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

  • 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:

    • Cardiac symptoms; any of the following should be considered for exclusion:

      • 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
      • Are pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01857271
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Haiying Cheng, Albert Einstein College of Medicine
Study Sponsor  ICMJE Albert Einstein College of Medicine
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Haiying Cheng Albert Einstein College of Medicine
PRS Account Albert Einstein College of Medicine
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP