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

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

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 .

Inclusion Criteria:

1. Aged 18-75 years old, both gender;

2. ECOG: 0-1;

3. Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ;

4. 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;

5. 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);

6. Life expectancy of at least 12 weeks;

7. 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;

8. Signed informed consent.

Exclusion Criteria:

1. Hypersensitivity reaction to the interventional drugs;
2. Pregnant or breastfeeding;
3. Women or men of childbearing age who disagree with the use of effective contraceptive measures during the study period;
4. Brain metastase ;
5. Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer