Paclitaxel Micelles for Injection / Paclitaxel Injection in Combination With Cisplatin for First-line Therapy of Advanced NSCLC

• Status: Active, not recruiting
• Trial end date: 2021-12-01

Summary

An open-label randomized and controlled clinical trial: This study was to compare the anticancer efficacy and safety in the First-Line Treatment in patients with Advanced Non-Small-Cell Lung Cancer with Paclitaxel Micelles for Injection In combination with Cisplatin versus Paclitaxel Injection Containing Cremophor EL(polyoxyethylenated castor oil) In combination with Cisplatin in the way of an open-label, randomized controlled clinical trial.

Treatment Protocol:

The subjects were randomized in the Paclitaxel Micelles for Injection Group and the Paclitaxel Injection Group by the proportion of 2:1. The centralized randomization method was adopted in this trial. Since the study was a comparison of first-line treatment, the test for superiority was adopted. The objective response rate was the primary indicator of efficacy in this study.

Trial Group:

Paclitaxel Micelles for Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.

No pretreatment, including anti-allergic prevention and antiemetic prophylaxis, was required for the patients before infusion of Paclitaxel Micelles for Injection patients.

Control Group:

Conventional Paclitaxel Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.

Standard preventive treatment must be given to patients in accordance with the specific requirements in specifications of Paclitaxel Injection.

Regardless of the Trial Group or the Control Group, six treatment periods shall be the upper limit.

To estimate the sample size based on objective remission indicators (CR + PR) in the study. Hypothesis: the objective remission rate of the Paclitaxel Micelles for Injection combined with Cisplatin in the Trial Group is different with that of first-line treatment of advanced non-small cell lung cancer, and is also different with that of the Cremophor EL-containing Paclitaxel Injection combined with Cisplatin in the Control Group. Trial parameter settings: assuming α = 0.05 and 1-β = 80%, the Trial Group: Control Group is designed as per the proportion of 2: 1. According to the sample size formula , a total of 426 patients is required, including 284 patients assigned in the Trial Group and 142 in the Control Group. In consideration of case expulsion in the process of clinical, enlarged by 10%, actually 468 cases were included in the groups, including 312 in the Trial Group and 156 in the Control Group.

• Phase: Phase 3

Details

• Lead Sponsor: Shanghai Yizhong Biotechnology Co., Ltd.
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel