Phase II Study Evaluating The Safety And Response To Neoadjuvant Dasatinib In Early Stage Non-Small Cell Lung Cancer
Status:
Terminated
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
Src expression has been identified in a majority of Non-Small Cell Lung Cancer (NSCLC) cell
lines and there is preclinical evidence that Src family kinases may be important in hypoxic
growth and angiogenesis in NSCLC. We hypothesize that the inhibition of Src pathway with
dasatinib will demonstrate anti-tumor activity in early stage NSCLC, with a tolerable safety
profile.
Patients will receive dasatinib, a Src inhibitor, for 3 weeks prior to surgical resection for
early stage NSCLC. Fresh frozen tumor tissue is needed for genomic analysis. If fresh frozen
tumor tissue is not available from the initial diagnosis, a biopsy will be required to
participate in this trial. A second tumor sample will be obtained at time of surgical
resection to evaluate for changes in genomic expression profiles.
Patients will be eligible to receive 3 months of adjuvant dasatinib therapy after completion
of standard adjuvant therapy or after recovery from surgery if no standard adjuvant therapy
is given, if there is evidence of neoadjuvant tumor response (radiologic and/or pathologic)
to dasatinib.
Many patients who present with NSCLC are active smokers. Patients who are smoking up until
the time of their surgery experience increased peri-operative complications compared to
patients who have not smoked cigarettes immediately prior to surgery. While this trial will
not be limited to active smokers, the period of smoking cessation prior to surgery is an
attractive window of opportunity during which the potentially active novel anticancer therapy
dasatinib can be offered to the patient.