The purpose of this study is to investigate the efficacy and the safety of paclitaxel liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced squamous non-small-cell lung cancer .
The purpose of this study is to investigate the efficacy and safety of paclitaxel liposome and cisplatin compared with gemcitabine and cisplatin as first-line therapy in advanced squamous non-small-cell lung cancer .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
536
Paclitaxel liposome injection 175 mg/m\^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
Gemcitabine 1000 mg/m\^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.
Cisplatin 75 mg/m\^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
Progression Free Survival
Progression free survival will be calculated from study entry to documented disease progression using RECISTv1.1 or death from any cause, whichever occurs first.
Time frame: From study entry to measured progressive disease, up to 2 years
Objective Response Rate
Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response .
Time frame: From study entry to measured progressive disease, up to 2 years
Overall Survival
Overall survival is defined from study entry to the date of death from any cause.
Time frame: From study entry to death from any cause, up to 2 years
Adverse events
Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0
Time frame: From baseline until 21 days after the last dose
Quality of Life questionnaire
The quality of life is assessed using the European Organization for the Research and Treatment of Cancer Questionnaire Core-30 (EORTC QLQ-C30) and Quality of Life Questionnaire Lung Cancer 13(QLQ-LC13).
Time frame: From study entry to measured progressive disease, up to 2 years
Correlation between gene sequence or expression level and therapeutic effect
Correlation between gene sequence or expression level and therapeutic effect is assessed using the blood or tumor tissue of subjects by genetic testing
Time frame: From study entry untill radiological disease progression, up to 2 years
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