Stage IIIA Non-Small Cell Lung Cancer Clinical Trial
Official title:
Phase II Multicenter Trial of Neoadjuvant Cisplatin and Nab-paclitaxel for (N2) Defined Stage IIIA Non-Small Cell Lung Cancer (NSCLC)
The purpose of this research study is to determine whether giving cisplatin and nab-paclitaxel before surgery will reduce the presence of disease in certain areas of the lung at the time of surgery.
Objectives
To estimate the rate of N2 nodal clearance at time of surgery in patients with NSCLC
undergoing treatment with neoadjuvant nab-paclitaxel plus cisplatin and surgery.
Estimate response rate and complete response rate in non-small cell lung cancer (NSCLC)
after 3 cycles of neoadjuvant nab-paclitaxel plus cisplatin
Estimate complete pathological response of primary tumor and lymph nodes at the time of
surgery in patients with NSCLC undergoing treatment with neoadjuvant nab-paclitaxel plus
cisplatin
Estimate disease free survival for all patients who undergo surgery and also stratified by
nodal clearance
Patients will be assigned to receive three (3) cycles of cisplatin (mg/m2) and
nab-paclitaxel (125 mg/m2). Surgery will then be conducted per standard of care.
Approximately 4-12 weeks after the surgical resection, patients will receive one of three
available treatment regimens based on the results of the surgical reports, which include:
Two four week cycles of therapy of Cisplatin and Nab-paclitaxel; Four three-week cycles of
Cisplatin and Pemetrexed, or four three-week cycles of Cisplatin and Gemcitabine
Thirty (30) days after treatment ends, subjects will be followed for any ongoing serious
adverse events, if necessary, and every 3-6 months thereafter for two years.
After the two years of follow-up, subjects will be followed for survival and disease status
Estimate overall survival for entire group and stratified by nodal clearance
To estimate event free survival (EFS)
Estimate time to distant recurrence and time to local recurrence following total study
procedures
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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