Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medical University of South Carolina
With
Boehringer Ingelheim
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Histologically confirmed NSCLC, who are deemed to be surgical candidates by standard criteria. Patients with all histologies will be allowed to enroll.
Patients with Stage IA to IIIA disease
ECOG Performance Status 0-1
Measurable disease by RECIST 1.1 criteria
Mediastinoscopy and/or Endoscopic Bronchial Ultrasound (EBUS) and/or Endoscopic Ultrasound (EUS) for complete surgical staging when clinically indicated
Total bilirubin ≤1.5 mg/dl, SGOT (AST) and SGPT (ALT)≥ 3 x ULN
Serum creatinine ≤ 1.5 mg/dl
Serious, active infections must be controlled. Patients may be enrolled while still on antibiotics as long as clinical signs of active infection have resolved.
A signed informed consent document (ICD)
Patients 18 years or older
Able and willing to take oral medications
You may not be if
Known preexisting lung disease.
History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption or CTC grade ≥2 diarrhea of any etiology.
Baseline (\<1 month before treatment) cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram
Patients may not be receiving any other investigational agents.
History of allergic reactions to anilinoquinazolins like gefitinib, erlotinib or BIBW 2992
Uncontrolled intercurrent illness that would preclude a patient from undergoing surgery
Psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant (positive pregnancy test) or lactating
Inability to comply with study and/or follow-up procedures
Patients who are not surgical candidates or refuse surgery
