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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

536 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-06-30

Brief Summary

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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 .

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Detailed Description

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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 .

Conditions

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Squamous Non-small-cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Paclitaxel Liposome

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Interventions

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Paclitaxel Liposome

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

Intervention Type DRUG

Gemcitabine

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

Intervention Type DRUG

Cisplatin

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

Intervention Type DRUG

Other Intervention Names

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Lipusu® Gemzar® Nuoxin®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No