Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU)

Study Overview
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Brief Summary
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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 .

Detailed Description
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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 .

Official Title
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A Multicenter, Randomized, Open-label, Parallel-group Study of Paclitaxel Liposome and Cisplatin Compared With Gemcitabine and Cisplatin as First-line Therapy in Advanced Squamous Non-Small-Cell Lung Cancer

Conditions
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Squamous Non-small-cell Lung Cancer

Intervention / Treatment
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* Drug: Paclitaxel Liposome
* Drug: Gemcitabine
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-75 years old, both gender; ECOG: 0-1; Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ; No prior chemotherapy, biological therapy or immunotherapy; or subjects have recurrence and metastasis more than 6 months after the end of chemotherapy, but not gemcitabine or paclitaxel; At least one radiographically measurable or assessable lesion on chest CG according to RECIST1.1 (response evaluation criteria of solid tumors); regional lymph node metastases may also be measured or assessed by imaging (mediastinal lymph nodes); Life expectancy of at least 12 weeks; Before treatment, blood tests or biochemical measurements must meet the following criteria: White blood cell count (WBC)≥ 4.0*10^9/L; Neutrophil count (ANC)≥ 2.0*10^9/L; Platelet count (PLT)≥ 100*10^9/L; Hemoglobin (Hb)≥ 100g/L; Hepatic function: serum bilirubin ≤ 1.5 times the upper normal limit,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit; Renal function: creatinine ≤ 1.5 times the upper normal limit; Signed informed consent. Exclusion Criteria: Hypersensitivity reaction to the interventional drugs; Pregnant or breastfeeding; Women or men of childbearing age who disagree with the use of effective contraceptive measures during the study period; Brain metastase ; Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LP group<br>Liposome paclitaxel(Lipusu®) plus cisplatin. Paclitaxel liposome Sterile injection powder 175 mg/m^2, given on day 1 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. | Drug: Paclitaxel Liposome<br>* Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.<br>* Other names: Lipusu®;Drug: Cisplatin<br>* Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.<br>* Other names: Nuoxin®;|
| Active Comparator: GP group<br>Gemcitabine (Gemzar®) plus cisplatin. Gemcitabine hydrochloride for injection 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. | Drug: Gemcitabine<br>* Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.<br>* Other names: Gemzar®;Drug: Cisplatin<br>* Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.<br>* Other names: Nuoxin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From study entry to measured progressive disease, up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response . | 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. | 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 | 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). | 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 | From study entry untill radiological disease progression, up to 2 years |