Clinical trial NCT02996214: Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Squamous Non-small-cell Lung Cancer
Lead sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-12-19
Enrollment: 536
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Progression Free Survival
timeFrame: From study entry to measured progressive disease, up to 2 years
Secondary outcomes:
measure: Objective Response Rate
timeFrame: From study entry to measured progressive disease, up to 2 years
measure: Overall Survival
timeFrame: From study entry to death from any cause, up to 2 years
measure: Adverse events
timeFrame: From baseline until 21 days after the last dose
measure: Quality of Life questionnaire
timeFrame: From study entry to measured progressive disease, up to 2 years
measure: Correlation between gene sequence or expression level and therapeutic effect
timeFrame: From study entry untill radiological disease progression, up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: caicun zhou, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang J, Pan Y, Shi Q, Zhang G, Jiang L, Dong X, Gu K, Wang H, Zhang X, Yang N, Li Y, Xiong J, Yi T, Peng M, Song Y, Fan Y, Cui J, Chen G, Tan W, Zang A, Guo Q, Zhao G, Wang Z, He J, Yao W, Wu X, Chen K, Hu X, Hu C, Yue L, Jiang D, Wang G, Liu J, Yu G, Li J, Bai J, Xie W, Zhao W, Wu L, Zhou C. Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study. Cancer Commun (Lond). 2022 Jan;42(1):3-16. doi: 10.1002/cac2.12225. Epub 2021 Oct 26.