Clinical trial · Interventional
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
NCT02996214CI-TRIAL-00043399LIPUSUunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Non-small-cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Paclitaxel Liposome | Drug | Paclitaxel Liposome | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LP group
- description
- 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.
- interventionNames
- Drug: Paclitaxel Liposome
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- GP group
- description
- 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.
- interventionNames
- Drug: Gemcitabine
- Drug: Cisplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZhang 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. PMID 34699693