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

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 .

Study Overview

• Status: Unknown
• Conditions: Squamous Non-small-cell Lung Cancer
• Intervention / Treatment: Drug: Paclitaxel Liposome; Drug: Cisplatin; Drug: Gemcitabine

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 536
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.; Other Names: Lipusu®; Drug: Cisplatin; Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.; Other Names: Nuoxin®
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: Cisplatin; Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.; Other Names: Nuoxin®; Drug: Gemcitabine; Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.; Other Names: Gemzar®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response .	From study entry to measured progressive disease, up to 2 years
Overall Survival	Overall survival is defined from study entry to the date of death from any cause.	From study entry to death from any cause, up to 2 years
Adverse events	Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0	From baseline until 21 days after the last dose
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).	From study entry to measured progressive disease, up to 2 years
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	From study entry untill radiological disease progression, up to 2 years

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ACTUAL): December 1, 2019
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: December 4, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (ESTIMATE): December 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Gemcitabine; Paclitaxel; Cisplatin
• Other Study ID Numbers: LY-TM-LPS-2016-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO