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