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

Luye Pharma Group

Status and phase: Unknown; Phase 4

Conditions: Squamous Non-small-cell Lung Cancer

Treatments: Drug: Gemcitabine; Drug: Cisplatin; Drug: Paclitaxel Liposome

Study type: Interventional

Funder types: Industry

Identifiers

NCT02996214

LY-TM-LPS-2016-01

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 536 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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536 participants in 2 patient groups

LP group

Experimental group

Description:

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.

Treatment:

Drug: Paclitaxel Liposome

Drug: Cisplatin

GP group

Active Comparator group

Description:

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.

Treatment:

Drug: Gemcitabine

Drug: Cisplatin