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

NCT02996214 | Unknown Phase 4 DMC

• 1 other identifier: LY-TM-LPS-2016-01
• Study Type: interventional
• Target: 536
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Squamous Non-small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Objective Response Rate

  From study entry to measured progressive disease, up to 2 years

• Overall Survival

  From study entry to death from any cause, up to 2 years

• Adverse events

  From baseline until 21 days after the last dose

• Quality of Life questionnaire

  From study entry to measured progressive disease, up to 2 years

• Correlation between gene sequence or expression level and therapeutic effect

  From study entry untill radiological disease progression, up to 2 years

Study Arms (2)

LP group

EXPERIMENTAL

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; Drug: Cisplatin

GP group

ACTIVE COMPARATOR

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; Drug: Cisplatin

Interventions

Paclitaxel Liposome DRUG

Paclitaxel liposome injection 175 mg/m\^2, given on day 1 of a 21-day cycle, for 4-6 cycles.

Also known as: Lipusu®

LP group

Gemcitabine DRUG

Gemcitabine 1000 mg/m\^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.

Also known as: Gemzar®

GP group

Cisplatin DRUG

Cisplatin 75 mg/m\^2, given on day 1 of a 21-day cycle, for 4-6 cycles.

Also known as: Nuoxin®

GP group; LP group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing Luye Sike Pharmaceutical Co., Ltd.: lead

Related Publications (1)

• 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.

  PMID: 34699693 DERIVED

MeSH Terms

Interventions

Gemcitabine; Cisplatin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• caicun zhou, doctor

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2016
• First Posted: December 19, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: February 13, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share