A Randomized Phase III Study Comparing Carboplatin With Nab-Paclitaxel Versus Docetaxel for Elderly Patients With Squamous-Cell Lung Cancer: Study Protocol

Background: Treatment with carboplatin (CBDCA) with weekly paclitaxel (PTX) has shown survival benefits compared with vinorelbine or gemcitabine in elderly patients with non-small-cell carcinoma (NSCLC). Docetaxel (DOC), however, remains a standard treatment in NSCLC. The 130-nm albumin-bound formulation of PTX (nab-PTX) has shown activity in NSCLC. Treatment with CBDCA with weekly nab-PTX showed significantly higher efficacy than CBDCA with PTX in patients with squamous histology and significantly increased overall survival (OS) in patients aged 70 years and older. Patients and Methods: This randomized, multicenter, phase III trial (UMIN000019843) was designed to compare the efficacy and safety of CBDCA with nab-PTX with DOC in patients aged 70 years and older with advanced squamous NSCLC. Elderly patients who have received no previous chemotherapy for advanced/metastatic squamous NSCLC with Eastern Cooperative Oncology Group performance status of 0 or 1 will be randomized 1:1 to DOC (60 mg/m ² intravenous [I.V.] on day 1) or CBDCA (area under the blood concentration time curve 6 on day 1) with nab-PTX (100 mg/m ² I.V. on days 1, 8, and 15) of each 21-day cycle. The primary end point is OS. Recruitment began in December 2015 and planned enrollment is 250 patients. Conclusion: If OS is greater in patients treated with CBDCA with nab-PTX than with DOC, this study will provide a new standard of care for elderly patients with squamous NSCLC.