Trial Information

A Phase II Study of Cisplatin Plus Docetaxel as Neoadjuvant Therapy for Stages IB Through Selected IIIA NSCLC

Non-small cell lung cancer (NSCLC) accounts for 80% of new lung cancer diagnoses in the US.
Surgery is the primary most successful treatment for early stage patients. However, even
lung cancers caught at an early stage (stage IB through selected IIIA) have 5 year survivals
after surgery at a rate of only 10-60%. Postoperative platinum based chemotherapy offers a
4-15% survival benefit, depending on stage in fit patients after complete surgical removal
of early stage disease. Preoperative platinum based chemotherapy has been shown in small
randomized trials to benefit patients with stage IIIA, N2 positive disease, but is not
standard of care in earlier stage disease, such as the population in this study.

The combination of cisplatin and docetaxel is approved in the US for front line therapy of
stage IV NSCLC based on randomized clinical data showing efficacy and manageable toxicity.
Given the efficacy and tolerance of this combination in the metastatic setting, this regimen
is an obvious choice for study in the neoadjuvant setting.

PET imaging is approved in the US for determining size, site and spread of lung cancer
(staging) and has been shown to reduce unnecessary surgery when used as part of preoperative
evaluation. Because NSCLC is not 100% responsive to chemotherapy and CT scans may not show a
change in tumor size until after several cycles of chemotherapy, PET imaging might be an
effective way to provide an earlier and more reliable estimate of response.

Preoperative chemotherapy will be given for a total of two cycles 21 days apart if any
adverse events have resolved and there is no evidence of disease progression. Patients will
undergo CT chest through liver and PET scans for restaging following the second cycle and
will then be scheduled for surgery 3-6 weeks after the second cycle of chemotherapy.
Patients who have responded according to CT and/or PET imaging, or surgical pathology will
go on to receive an additional two cycles of chemotherapy with docetaxel and cisplatin once
the patient has recovered from surgery.