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Randomized Blinded Phase III Assessment of Second or Third-Line Chemotherapy With Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients With Advanced Non-Small Cell Lung Cancer and With at Least One Measurable Lung Lesion
BeyondSprings Pharmaceuticals, Inc.
The primary purpose of the study is to compare the overall survival of NSCLC patients receiving second- or third-line chemotherapy with docetaxel + plinabulin (DP Arm) to patients treated with docetaxel + placebo (D Arm) for advanced or metastatic disease.
Secondary purposes of the study are:
1.To compare the neutropenia (frequency, severity and clinical sequelae), duration of response, quality of life, response rate and progression free survival in patients with NSCLC treated with DP to patients treated with D as second- or third-line chemotherapy for advanced or metastatic disease; and
2.To compare the safety and adverse event profiles of DP to D respectively, as well as dose delays, dose modifications, and/or dose discontinuation of docetaxel due to safety concerns in the two treatment arms.
3.To evaluate population pharmacokinetics in patients enrolled in China and western countries (US and Australia).