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

Squamous Non-small-cell Lung Cancer Clinical Trial

— LIPUSU  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02996214
• Other study ID #: LY-TM-LPS-2016-01
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 2016
• Est. completion date: June 2020

Study information

• Verified date: February 2020
• Source: Nanjing Luye Sike Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 536
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Squamous Non-small-cell Lung Cancer

Intervention

Drug:
• Paclitaxel Liposome
Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
• Gemcitabine
Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.
• Cisplatin
Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Luye Sike Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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