Squamous Non-small-cell Lung CancerPhase 4LIPUSUNCT02996214
Paclitaxel Liposome for Squamous Non-Small-cell Lung Cancer Study(LIPUSU)
A Phase 4 study testing Paclitaxel Liposome, Gemcitabine and Cisplatin in people with Squamous Non-small-cell Lung Cancer, run by Nanjing Luye Sike Pharmaceutical Co., Ltd..
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 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Squamous Non-small-cell Lung Cancer
- What is being tested?
- Paclitaxel Liposome, Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old, both gender;
- ECOG: 0-1;
- Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ;
- 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;
- 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);
- Life expectancy of at least 12 weeks;
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- 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;
- Signed informed consent.
Who cannot join
- Hypersensitivity reaction to the interventional drugs;
- Pregnant or breastfeeding;
- Women or men of childbearing age who disagree with the use of effective contraceptive measures during the study period;
- Brain metastase ;
- Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer
About this study
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
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 .
Read the 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 .
- Conditions
- Squamous Non-small-cell Lung Cancer
- Being tested
- Paclitaxel Liposome, Gemcitabine, Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel LiposomeDrug
Also called Lipusu®
Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
GemcitabineDrug
Also called Gemzar®
Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.
CisplatinDrug
Also called Nuoxin®
Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| LP group | Experimental | 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. Receives: Drug: Paclitaxel Liposome; Drug: Cisplatin |
| GP group | Active comparator | 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. Receives: Drug: Gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From study entry to measured progressive disease, up to 2 years
Secondary outcomes (5)
Objective Response Rate
Objective response rate is the percentage of participants who achieve best overall tumor response of complete response or partial response .
Measured: From study entry to measured progressive disease, up to 2 years
Overall Survival
Overall survival is defined from study entry to the date of death from any cause.
Measured: From study entry to death from any cause, up to 2 years
Adverse events
Adverse events is evaluated according to Common Terminology Criteria for Adverse Events Version 4.0
Measured: From baseline until 21 days after the last dose
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).
Measured: From study entry to measured progressive disease, up to 2 years
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
Measured: From study entry untill radiological disease progression, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Non-small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 536 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- caicun zhou, doctor, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996214
- Sponsor's protocol ID
- LY-TM-LPS-2016-01
- Acronym
- LIPUSU
- Status last verified
- Feb 2020
- First submitted
- 4 Dec 2016
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Zhang J, Pan Y, Shi Q, Zhang G, Jiang L, Dong X, Gu K, Wang H, Zhang X, Yang N, Li Y, Xiong J, Yi T, Peng M, Song Y, Fan Y, Cui J, Chen G, Tan W, Zang A, Guo Q, Zhao G, Wang Z, He J, Yao W, Wu X, Chen K, Hu X, Hu C, Yue L, Jiang D, Wang G, Liu J, Yu G, Li J, Bai J, Xie W, Zhao W, Wu L, Zhou C. Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study. Cancer Commun (Lond). 2022 Jan;42(1):3-16. doi: 10.1002/cac2.12225. Epub 2021 Oct 26.
PubMed 34699693
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02996214
- Acronym / sponsor ID
- LIPUSU / LY-TM-LPS-2016-01
- Conditions
- Squamous Non-small-cell Lung Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 536 participants (estimated)
- Lead sponsor
- Nanjing Luye Sike Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP group | Experimental | Drug: Paclitaxel Liposome, Drug: CisplatinLiposome 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 | Active comparator | Drug: Gemcitabine, Drug: CisplatinGemcitabine (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged 18-75 years old, both gender;
- ECOG: 0-1;
- Squamous non-small-cell lung cancer (stage IIIB or IV) confirmed by histologically or cytologically ;
- 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;
- 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);
Key exclusion criteria (5 listed)
- Hypersensitivity reaction to the interventional drugs;
- Pregnant or breastfeeding;
- Women or men of childbearing age who disagree with the use of effective contraceptive measures during the study period;
- Brain metastase ;
- Uncontrolled pleural effusion in patients with squamous non-small-cell lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel LiposomeAlso: Lipusu®Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. | Drug | LP group |
| GemcitabineAlso: Gemzar®Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles. | Drug | GP group |
| CisplatinAlso: Nuoxin®Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles. | Drug | GP group, LP group |
Primary outcome
Progression Free Survival
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 using RECISTv1.1 or death from any cause, whichever occurs first.
5 secondary outcomes
Objective Response Rate
Time frame: From study entry to measured progressive disease, up to 2 years
Overall Survival
Time frame: From study entry to death from any cause, up to 2 years
Adverse events
Time frame: From baseline until 21 days after the last dose
Quality of Life questionnaire
Time frame: From study entry to measured progressive disease, up to 2 years
Correlation between gene sequence or expression level and therapeutic effect
Time frame: From study entry untill radiological disease progression, up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 34699693Zhang J, Pan Y, Shi Q, Zhang G, Jiang L, Dong X, Gu K, Wang H, Zhang X, Yang N, Li Y, Xiong J, Yi T, Peng M, Song Y, Fan Y, Cui J, Chen G, Tan W, Zang A, Guo Q, Zhao G, Wang Z, He J, Yao W, Wu X, Chen K, Hu X, Hu C, Yue L, Jiang D, Wang G, Liu J, Yu G, Li J, Bai J, Xie W, Zhao W, Wu L, Zhou C. Paclitaxel liposome for injection (Lipusu) plus cisplatin versus gemcitabine plus cisplatin in the first-line treatment of locally advanced or metastatic lung squamous cell carcinoma: A multicenter, randomized, open-label, parallel controlled clinical study. Cancer Commun (Lond). 2022 Jan;42(1):3-16. doi: 10.1002/cac2.12225. Epub 2021 Oct 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
caicun zhou, doctor principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paclitaxel Liposome, Gemcitabine and Cisplatin in people with Squamous Non-small-cell Lung Cancer, run by Nanjing Luye Sike Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: From study entry to measured progressive disease, up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02996214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.