Clinical Trials at Englewood Hospital: Lung Cancer
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EHMC IRB Study #: E-14-551
Dr. Lewis Attas
A Phase III, Randomized, Open-Label, Crossover, Multi-Center, Safety and Efficacy Study to Evaluate Nab-Paclitaxel (ABRAXANE®) as Maintenance Treatment after Induction with nab-Paclitaxel Plus Carboplatin in Subjects with Squamous Cell Non-Small Cell Lung Cancer (NSCLC)
Patients with squamous cell NSCLC stage IIIB or IV with no prior chemotherapy for metastatic disease and ≥ 18 years old will be eligible for this study.
To evaluate progression free survival (PFS) with nab-paclitaxel as maintenance treatment after response or stable disease (SD) with nab-paclitaxel plus carboplatin in subjects with squamous cell NSCLC.
Summary of procedures:
Patients eligible for standard treatment with nab-paclitaxel plus carboplatin for 4 "Induction" cycles will be enrolled. After 4 cycles of Induction, if the patient has a radiologically-assessed (CT or MRI scan) response to the Induction (CR, PR, or SD), they will continue on to the Maintenance part of the study. In Maintenance, subjects are randomized 2:1 to receive either (1) nab-Pacitaxel plus best supportive care (BSC) vs. (2) best supportive care (BSC) alone. Maintenance cycles continue every 21 days until disease progression or unacceptable toxicity. Subjects in the BCS alone arm are eligible to cross over to the nab-Paclitaxel plus BSC arm, if they experience progression of disease.
*Each listing only contains a summary of the study information. Please contact the Principal Investigator or Study Coordinator for the full details on a particular study.