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EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III Non-small Cell Lung Cancer Patients With EGFR Mutations (EVENT Trial).

Phase 2
18 Years
Not Enrolling
Non-Small Cell Lung Cancer

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Trial Information

EValuation of Erlotinib as a Neoadjuvant Therapy in Stage III Non-small Cell Lung Cancer Patients With EGFR Mutations (EVENT Trial).

Inclusion Criteria:

- Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIA or
IIIB non-small cell lung cancer within 4 weeks of registration.

- Activating mutation in EGFR oncogene

- 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:

1. History/physical examination prior to registration.

2. CT Scan of the chest or PET Scan within 28 days of study entry

3. CT Scan of abdomen or MRI of abdomen or Pet Scan within 28 days of study entry

4. An MRI of the brain or Head CT Scan with contrast within 28 days of study entry

5. Total body PET scan within 28 days of study entry

6. Mediastinoscopies are highly recommended.

- Patients must have measurable or evaluable disease.

- ECOG Performance Status 0-2.

- Age > 18.

- CBC/differential obtained within 2 weeks prior to registration on study, with
adequate bone marrow function defined as follows:

1. Absolute neutrophil count (ANC) >1,500 cells/ul

2. Platelets > 100,000 cells/ul

3. Hemoglobin > 9.0 g/dl (Note: The use of transfusion or other intervention to
achieve Hgb > g/dl is acceptable.)

4. Serum creatinine < 1.5 x ULN

5. Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)

6. AST and ALT < 2.5 x the ULN

7. Women of childbearing potential must have:

1. A negative serum or urine pregnancy test (sensitivity 25IU HCG/L) within 72
hours prior to the start of study drug administration

2. 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

- Ability to take oral medication

- Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria:

- Pleural or pericardial effusion

a. Pleural effusions allowed if one of the following conditions are met:

1. Negative cytology after adequate sampling by thoracentisis

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:

1. Cardiac Symptoms; any of the following should be considered for exclusion:

1. Uncontrolled angina, congestive heart failure or MI within (6 months)

2. Diagnosed congenital long QT syndrome

3. Any history of clinically significant ventricular arrhythmias (such as
ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)

4. Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)

2. History of significant bleeding disorder unrelated to cancer, including:

1. Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)

2. Diagnosed acquired bleeding disorder within one year (e.g., acquired
anti-factor VIII antibodies)

3. 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.

- Women who:

1. 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

2. have a positive pregnancy test at baseline, or

3. are pregnant or breastfeeding

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of mediastinal nodal clearance after neoadjuvant erlotinib.

Outcome Description:

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.

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

Bilal Piperdi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung cancer EGFR 3 erlotinib Tarceva surgery target
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Montefiore Medical Center Bronx, New York  10467-2490
Columbia University Medical Center New York, New York  10032
Beth Israel Hospital New York, New York  10003