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Lipusu Advanced Squamous Cell Carcinoma of Lung Study Carboplatin in Advanced Squamous Cell Carcinoma of Lung (LIPUSU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02996214
Recruitment Status : Not yet recruiting
First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Sponsor:
Information provided by (Responsible Party):
Nanjing Luye Sike Pharmaceutical Co., Ltd.

Brief Summary:
The purpose of this study is to investigate the efficacy and the safety of paclitaxel liposome injection and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell carcinoma of lung.

Condition or disease Intervention/treatment Phase
Lung Squamous Cell Carcinoma Drug: Paclitaxel Liposome Drug: Gemcitabine Drug: Cisplatin Phase 4

Detailed Description:
The purpose of this study is to investigate the efficacy and the safety of paclitaxel liposome injection and carboplatin compared with gemcitabine and carboplatin as first-line therapy in advanced squamous cell carcinoma of lung. This study is the Superiority Trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 536 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label, Parallel-group Study of Paclitaxel Liposome Injection and Cisplatin Compared With Gemcitabine and Carboplatin as First-line Therapy in Advanced Squamous Cell Carcinoma of Lung
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LP group
Liposome paclitaxel(Lipusu®) plus cisplatin. Paclitaxel liposome Sterile injection powder 175 mg/m2, given on day 1 of a 21-day cycle, for 6 cycles. Cisplatin 75 mg/m2, given on day 1 of a 21-day cycle, for 6 cycles.
Drug: Paclitaxel Liposome
Paclitaxel liposome injection 175 mg/m2, given on day 1 of a 21-day cycle, for 6 cycles.
Other Name: Lipusu®

Drug: Cisplatin
Cisplatin 75 mg/m2, given on day 1 of a 21-day cycle, for 6 cycles.
Other Name: Nuoxin®

Active Comparator: GP group
Gemcitabine (Gemzar®) plus cisplatin. Gemcitabine hydrochloride for injection 1000 mg/m2, given on days 1 and 8 of a 21-day cycle, for 6 cycles. Cisplatin 75 mg/m2, given on day 1 of a 21-day cycle, for 6 cycles.
Drug: Gemcitabine
Gemcitabine 1000 mg/m2, given on days 1 and 8 of a 21-day cycle, for 6 cycles.
Other Name: Gemzar®

Drug: Cisplatin
Cisplatin 75 mg/m2, given on day 1 of a 21-day cycle, for 6 cycles.
Other Name: Nuoxin®




Primary Outcome Measures :
  1. progression free survival (PFS) [ Time Frame: From study entry to measured progressive disease,up to 2 years ]
    Progression free survival will be calculated from study entry to documented disease progression or death from any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From study entry to measured progressive disease,up to 2 years ]
    ORR is the percentage of participants who achieve best overall tumor response of complete response (CR) or partial response (PR).

  2. Regional lymph node remission rate [ Time Frame: From study entry to measured progressive disease,up to 2 years ]
  3. Overall Survival (OS) [ Time Frame: From study entry to death from any cause,up to 2 years ]
    Overall survival (OS) duration is defined from study entry to the date of death from any cause.

  4. Safety Assessment [ Time Frame: From study entry to death from any cause,up to 2 years ]
    Safety assessment is evaluated by National Cancer Institute(NCI)Common Terminology Criteria for adverse events (CTCAE 4.0).

  5. Quality of Life [ Time Frame: 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 (EORTC QLQ-C30)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-75 years old, both gender;
  2. ECOG: 0-1;
  3. Histologically or cytologically confirmed diagnosis of squamous non-small-cell lung cancer (stage IIIB or IV);
  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*109/L;
    • Neutrophil count (ANC)≥ 2.0*109/L;
    • Platelet count (PLT)≥ 100*109/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;

2.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996214


Contacts
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Contact: caicun zhou, doctor 13301825532 caicunzhoudr@163.com

Sponsors and Collaborators
Nanjing Luye Sike Pharmaceutical Co., Ltd.

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Responsible Party: Nanjing Luye Sike Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02996214    
Other Study ID Numbers: LY-TM-LPS-2016-01
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors