Squamous Non-small-cell Lung Cancer
Conditions
Brief summary
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
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 .
Interventions
Paclitaxel liposome injection 175 mg/m\^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
DRUGGemcitabine
Gemcitabine 1000 mg/m\^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.
DRUGCisplatin
Cisplatin 75 mg/m\^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
Sponsors
Nanjing Luye Sike Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | From study entry to measured progressive disease, up to 2 years | Progression free survival will be calculated from study entry to documented disease progression using RECISTv1.1 or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | From study entry to measured progressive disease, up to 2 years | Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response . |
| Overall Survival | From study entry to death from any cause, up to 2 years | Overall survival is defined from study entry to the date of death from any cause. |
| Adverse events | From baseline until 21 days after the last dose | Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0 |
| Quality of Life questionnaire | From study entry to measured progressive disease, up to 2 years | 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). |
| Correlation between gene sequence or expression level and therapeutic effect | From study entry untill radiological disease progression, up to 2 years | Correlation between gene sequence or expression level and therapeutic effect is assessed using the blood or tumor tissue of subjects by genetic testing |
Outcome results
None listed