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Status unknownNCT02996214LIPUSUUpdated Feb 13, 2020

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

A Phase 4 interventional study of Paclitaxel Liposome and Gemcitabine in Squamous Non-small-cell Lung Cancer, sponsored by Nanjing Luye Sike Pharmaceutical Co., Ltd.. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-02-13.

Sponsored by Nanjing Luye Sike Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
536
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 .

Read the 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 .

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Conditions studied

  • Squamous Non-small-cell Lung Cancer
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 536 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Nanjing Luye Sike Pharmaceutical Co., Ltd. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
536 participants (estimated)

Study arms

  • Experimental
    LP group

    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

  • Active comparator
    GP group

    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

  • DrugPaclitaxel Liposome

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

    Also known as: Lipusu®

  • DrugGemcitabine

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

    Also known as: Gemzar®

  • DrugCisplatin

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

    Also known as: Nuoxin®

06

What researchers measure

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.

    Time frame: From study entry to measured progressive disease, up to 2 years

Secondary outcomes

  1. Objective Response Rate

    Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response .

    Time frame: From study entry to measured progressive disease, up to 2 years

  2. Overall Survival

    Overall survival is defined from study entry to the date of death from any cause.

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

  3. Adverse events

    Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0

    Time frame: From baseline until 21 days after the last dose

  4. Quality of Life questionnaire

    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).

    Time frame: From study entry to measured progressive disease, up to 2 years

  5. Correlation between gene sequence or expression level and therapeutic effect

    Correlation between gene sequence or expression level and therapeutic effect is assessed using the blood or tumor tissue of subjects by genetic testing

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 34699693 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02996214
Lead sponsor
Nanjing Luye Sike Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 19, 2016
Start date
Nov 2016
Primary completion
Dec 2019
Completion
Jun 2020 (estimated)
Last update
Feb 13, 2020

Study contacts

caicun zhou, doctor
principal investigator · Shanghai Pulmonary Hospital, Shanghai, China

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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