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

Phase 4

• Conditions: Squamous Non-small-cell Lung Cancer
• Interventions: Drug: Paclitaxel Liposome; Drug: Gemcitabine; Drug: Cisplatin

• Registration Number: NCT02996214
• Lead Sponsor: Nanjing Luye Sike Pharmaceutical Co., Ltd.

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 .

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-04
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Primary Completion: 2019-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-13
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 536

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LP group	Paclitaxel Liposome	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.
LP group	Cisplatin	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.
GP group	Cisplatin	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.
GP group	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	From study entry to measured progressive disease, up to 2 years	Progression free survival will be calculated from study entry to documented disease progression using RECISTv1.1 or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate	From study entry to measured progressive disease, up to 2 years	Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response .
Overall Survival	From study entry to death from any cause, up to 2 years	Overall survival is defined from study entry to the date of death from any cause.
Adverse events	From baseline until 21 days after the last dose	Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0
Correlation between gene sequence or expression level and therapeutic effect	From study entry untill radiological disease progression, up to 2 years	Correlation between gene sequence or expression level and therapeutic effect is assessed using the blood or tumor tissue of subjects by genetic testing
Quality of Life questionnaire	From study entry to measured progressive disease, up to 2 years	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).