Non-Small Cell Lung Cancer(NSCLC)Phase 3NCT02667743

Paclitaxel Micelles for Injection / Paclitaxel Injection in Combination With Cisplatin for First-line Therapy of Advanced NSCLC

A Phase 3 study testing Paclitaxel Micelles for Injection, Paclitaxel Injection and Cisplatin in people with Non-Small Cell Lung Cancer(NSCLC), run by Shanghai Yizhong Pharmaceutical Co., Ltd. at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

An open-label randomized and controlled clinical trial: This study was to compare the anticancer efficacy and safety in the First-Line Treatment in patients with Advanced Non-Small-Cell Lung Cancer with Paclitaxel Micelles for Injection In combination with Cisplatin versus Paclitaxel Injection Containing Cremophor… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Non-Small Cell Lung Cancer(NSCLC)
What is being tested?: Paclitaxel Micelles for Injection, Paclitaxel Injection and Cisplatin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 454 participants
Where: 3 sitesChina
Study dates: May 2015to Dec 2021
Phase: Phase 3
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

First-line patients with locally advanced or metastatic NSCLC (Clinical Stage of ⅢB/Ⅳ, TNM (primary tumor, regional nodes, metastasis) Staging Edition 7) confirmed by histological or cytological diagnosis or of postoperative recurrence;
First-line patients include:
Patients who are newly diagnosed as ⅢB/Ⅳ and have undergone no radiotherapy or chemotherapy or molecular targeting treatment;
Patients with postoperative reoccurrence and metastasis and receiving no adjuvant radiotherapy or chemotherapy or molecular targeting treatment;
Patients with postoperative reoccurrence and metastasis and receiving adjuvant radiotherapy or chemotherapy or molecular targeting treatment, but it has been more than one year since the end of such therapies or treatment.
Patients who have received prior radiotherapy can be enrolled. However, the radiation area must be <25% of bone marrow area, the prior radiotherapy has been completed at least 4 weeks before the enrollment, and the acute radiation toxicity must have been restored. Local lesions that have undergone radiotherapy are not allowed to be included in the measurable lesions save as such lesions with significant progress recorded after the last radiotherapy.

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Patients with available measurable lesions in line with the requirements of "measurable lesions" in the response evaluation criteria "RECIST Version 1.1". Lesions with at least one accurately measurable diameter (serve as the maximum diameter): the maximum diameter of target lesions with CT scan ≥20 mm or the maximum diameter with spiral CT or MRI scan ≥10 mm;
ECOG (Eastern Cooperative Oncology Group) score ≤ 1 points and expected survival of at least 3 months;
18 to 70 years old, male or female;
Blood picture and functions of major organs such as heart, lung, liver, kidneys are basically normal.
Blood routine test must meet the following criteria:
ANC≥1.5×109/L；
PLT≥100×109/L；
Hb≥90g/L。
Blood biochemical test must meet the following criteria:
Plasma total bilirubin ≤1.5 × upper limit of normal (ULN);
ALT (Alanine aminotransferase), AST (Aspartate transaminase) or AKP≤2.5 × ULN (for patients with hepatic metastases, ALT, AST or AKP≤5 × ULN; for patients with bone metastases, AKP≤10 × ULN);
Cr ≤1.5 × ULN;
Patients have no cardiac insufficiency symptoms at baseline; no serious abnormal signs in ECG
Efficacy of cancer-related imaging examinations are completed within 2 weeks before enrollment and clinical condition assessment, the three routine tests of blood, urea, and stool, blood biochemical examination, ECG, CEA (carcinoembryonic antigen) and other examinations completed within 1 week before enrollment;
Patients can understand the purpose of the clinical trial, participate out of their own will, and sign the informed consent;
Patients have good compliance, accept the doctor's follow-up evaluations, and voluntarily follow treatment protocol during the study;
Male or female patients with childbearing potential voluntarily take contraceptive measures during the trial.

Who cannot join

In case of any of the following circumstances, the patient is not allowed to participate in this study:
Patients known to have mutant EGFR (epidermal growth factor receptor), ALK (anaplastic lymphoma kinase) in genetic examinations;
Patients with primary brain or central nervous metastases (including leptomeningeal metastasis), excluding patients with asymptomatic single brain metastasis under strict control; and patients with central nervous tumors accompanied by cerebral hypertension or neuropsychiatric symptoms;
Patients with non-eliminated acute and chronic infections or patients also suffer from other serious diseases simultaneously;
Patients who cannot complete the entire trial process as the investigator may deem fit;
Patients with peripheral neuropathy above grade I;

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Patients with an allergic history to Paclitaxel;
The existence of a third space effusion that cannot be controlled by drainage or other means (such as middle - large pleural effusion, middle - large pericardial effusion and ascites); patients with asymptomatic small pleural effusion requiring no clinical intervention may be enrolled subject to strict control;
Patients with mental illness or mental disorders, poor compliance, or cannot account treatment responses;
Patients with poor tolerability due to serious organic diseases or major organ failure, such as decompensated heart and lung failure;
Patients with bleeding tendency diseases;
Organ transplant recipients;
Patients with drug abuse and other adverse drug addicts, long-term alcoholics and patients with AIDS and other infectious diseases;
Long-term users of adrenal corticosteroids or immunosuppressive agents;
Patients have suffered from other malignant cancers within 5 years (except for cured basal cell carcinoma and cervical carcinoma in situ);
Patients with active hepatitis and liver metastasis exceeding three-quarters of the whole liver.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Guangdong General Hospital
Guangzhou, Guangdong, 510080
Jiangsu Cancer Hospital
Nanjing, Zhejiang, 210009
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030

Other trials in China

About this study

Treatment Protocol:

The subjects were randomized in the Paclitaxel Micelles for Injection Group and the Paclitaxel Injection Group by the proportion of 2:1. The centralized randomization method was adopted in this trial. Since the study was a comparison of first-line treatment, the test for superiority was adopted. The objective response rate was the primary indicator of efficacy in this study.

Trial Group:

Paclitaxel Micelles for Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.

No pretreatment, including anti-allergic prevention and antiemetic prophylaxis, was required for the patients before infusion of Paclitaxel Micelles for Injection patients.

Control Group:

Conventional Paclitaxel Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.

Standard preventive treatment must be given to patients in accordance with the specific requirements in specifications of Paclitaxel Injection.

Regardless of the Trial Group or the Control Group, six treatment periods shall be the upper limit.

To estimate the sample size based on objective remission indicators (CR + PR) in the study. Hypothesis: the objective remission rate of the Paclitaxel Micelles for Injection combined with Cisplatin in the Trial Group is different with that of first-line treatment of advanced non-small cell lung cancer, and is also different with that of the Cremophor EL-containing Paclitaxel Injection combined with Cisplatin in the Control Group. Trial parameter settings: assuming α = 0.05 and 1-β = 80%, the Trial Group: Control Group is designed as per the proportion of 2: 1. According to the sample size formula , a total of 426 patients is required, including 284 patients assigned in the Trial Group and 142 in the Control Group. In consideration of case expulsion in the process of clinical, enlarged by 10%, actually 468 cases were included in the groups, including 312 in the Trial Group and 156 in the Control Group.

Conditions: Non-Small Cell Lung Cancer(NSCLC)
Being tested: Paclitaxel Micelles for Injection, Paclitaxel Injection, Cisplatin
Keywords: NSCLC, Paclitaxel Micelles for Injection
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paclitaxel Micelles for InjectionDrug
Paclitaxel InjectionDrug
CisplatinDrug

Study groups in NCT02667743
Study group	Role	What they receive
Paclitaxel Micelles for Injection + Cisplatin	Experimental	In the First Period, 230 mg/m2 of Paclitaxel Micelles for Injection was intravenously administrated for three hours without special infusion device, then 70 mg/m2 of Cisplatin was intravenously administrated for two hours. Three weeks constituted one course of treatment. In the Second Period, 300 mg/㎡ of Paclitaxel Micelles for Injection was intravenously administrated for three hours without special infusion device to patients whose minimum neutrophil ≥1.0 × 109 /L and minimum platelet count ≥80 × 109 /L and with no hematologic toxicity of grade II to IV occurred in the First Period. Then 70 mg/m2 of Cisplatin was intravenously administrated for two hours. Three weeks constituted one course of treatment. Receives: Drug: Paclitaxel Micelles for Injection; Drug: Cisplatin
Paclitaxel Injection + Cisplatin	Active comparator	175 mg/m2 of conventional Paclitaxel Injection was intravenously administrated for three hours, then 70 mg/m2 of Cisplatin was intravenously administrated for two hours. Three weeks constituted one course of treatment. Receives: Drug: Paclitaxel Injection; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Objective response rate
Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured: Baseline to measured PD (up to 36 months)

Secondary outcomes (5)

Progression-Free-Survival
PFS(Progression-Free-Survival) was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first.
Measured: Randomization to measured PD or date of death from any cause (up to 36 months)
Overall survival
Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.
Measured: Randomization to date of death from any cause (up to 36 months)
Incidence of Adverse Events，Serious Adverse Events.
Measured: up to 36 months
Incidence of bone marrow suppression.
Measured: up to 36 months
The number of patients with dose adjustment.
Measured: up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2015Dec 2021

First posted29 Jan 2016 (estimated)
Study startMay 2015
Primary completionJan 2019
Study completionDec 2021 (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 Non-Small Cell Lung Cancer(NSCLC)Studies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 454 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02667743
Sponsor's protocol ID: PM-03-2015
Status last verified: Mar 2020
First submitted: 20 Jan 2016
Last updated: 17 Mar 2021
Results posted: No

Publications

Shi M, Gu A, Tu H, Huang C, Wang H, Yu Z, Wang X, Cao L, Shu Y, Wang H, Yang R, Li X, Chang J, Hu Y, Shen P, Hu Y, Guo Z, Tao M, Zhang Y, Liu X, Sun Q, Zhang X, Jiang Z, Zhao J, Chen F, Yu H, Zhang W, Sun J, Li D, Zhou J, Han B, Wu YL. Comparing nanoparticle polymeric micellar paclitaxel and solvent-based paclitaxel as first-line treatment of advanced non-small-cell lung cancer: an open-label, randomized, multicenter, phase III trial. Ann Oncol. 2021 Jan;32(1):85-96. doi: 10.1016/j.annonc.2020.10.479. Epub 2020 Oct 29.
PubMed 33130217

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Non-Small Cell Lung Cancer(NSCLC) trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Paclitaxel Micelles for Injection / Paclitaxel Injection in Combination With Cisplatin for First-line Therapy of Advanced NSCLC
ClinicalTrials.gov ID: NCT02667743
Acronym / sponsor ID: PM-03-2015
Conditions: Non-Small Cell Lung Cancer(NSCLC)
Keywords: NSCLC, Paclitaxel Micelles for Injection
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 454 participants (actual)
Lead sponsor: Shanghai Yizhong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: May 2015 (actual)
Primary completion: Jan 2019 (actual)
Study completion: Dec 2021 (estimated)
First posted: 29 Jan 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.

Treatment Protocol:

Trial Group:

Paclitaxel Micelles for Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.

No pretreatment, including anti-allergic prevention and antiemetic prophylaxis, was required for the patients before infusion of Paclitaxel Micelles for Injection patients.

Control Group:

Conventional Paclitaxel Injection and Cisplatin was intravenously administrated. Three weeks constituted one course of treatment.

Standard preventive treatment must be given to patients in accordance with the specific requirements in specifications of Paclitaxel Injection.

Regardless of the Trial Group or the Control Group, six treatment periods shall be the upper limit.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Paclitaxel Micelles for Injection + Cisplatin	Experimental	Drug: Paclitaxel Micelles for Injection, Drug: CisplatinIn the First Period, 230 mg/m2 of Paclitaxel Micelles for Injection was intravenously administrated for three hours without special infusion device, then 70 mg/m2 of Cisplatin was intravenously administrated for two hours. Three weeks constituted one course of treatment. In the Second Period, 300 mg/㎡ of Paclitaxel Micelles for Injection was intravenously administrated for three hours without special infusion device to patients whose minimum neutrophil ≥1.0 × 109 /L and minimum platelet count ≥80 × 109 /L and with no hematologic toxicity of grade II to IV occurred in the First Period. Then 70 mg/m2 of Cisplatin was intravenously administrated for two hours. Three weeks constituted one course of treatment.
Paclitaxel Injection + Cisplatin	Active comparator	Drug: Paclitaxel Injection, Drug: Cisplatin175 mg/m2 of conventional Paclitaxel Injection was intravenously administrated for three hours, then 70 mg/m2 of Cisplatin was intravenously administrated for two hours. Three weeks constituted one course of treatment.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

First-line patients with locally advanced or metastatic NSCLC (Clinical Stage of ⅢB/Ⅳ, TNM (primary tumor, regional nodes, metastasis) Staging Edition 7) confirmed by histological or cytological diagnosis or of postoperative recurrence;
Patients with available measurable lesions in line with the requirements of "measurable lesions" in the response evaluation criteria "RECIST Version 1.1". Lesions with at least one accurately measurable diameter (serve as the maximum diameter): the maximum diameter of target lesions with CT scan ≥20 mm or the maximum diameter with spiral CT or MRI scan ≥10 mm;
ECOG (Eastern Cooperative Oncology Group) score ≤ 1 points and expected survival of at least 3 months;
18 to 70 years old, male or female;
Blood picture and functions of major organs such as heart, lung, liver, kidneys are basically normal.

Key exclusion criteria (16 listed)

In case of any of the following circumstances, the patient is not allowed to participate in this study:
Patients known to have mutant EGFR (epidermal growth factor receptor), ALK (anaplastic lymphoma kinase) in genetic examinations;
Patients with primary brain or central nervous metastases (including leptomeningeal metastasis), excluding patients with asymptomatic single brain metastasis under strict control; and patients with central nervous tumors accompanied by cerebral hypertension or neuropsychiatric symptoms;
Patients with non-eliminated acute and chronic infections or patients also suffer from other serious diseases simultaneously;
Patients who cannot complete the entire trial process as the investigator may deem fit;

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 Micelles for Injection	Drug	Paclitaxel Micelles for Injection + Cisplatin
Paclitaxel Injection	Drug	Paclitaxel Injection + Cisplatin
Cisplatin	Drug	Paclitaxel Injection + Cisplatin, Paclitaxel Micelles for Injection + Cisplatin

Primary outcome

Objective response rate
Time frame: Baseline to measured PD (up to 36 months)
Objective response rate is defined as the proportion of subjects with complete or partial response as determined by the investigator using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

5 secondary outcomes

Progression-Free-Survival
Time frame: Randomization to measured PD or date of death from any cause (up to 36 months)
Overall survival
Time frame: Randomization to date of death from any cause (up to 36 months)
Incidence of Adverse Events，Serious Adverse Events.
Time frame: up to 36 months
Incidence of bone marrow suppression.
Time frame: up to 36 months
The number of patients with dose adjustment.
Time frame: up to 36 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
Derived from this study: PubMed 33130217Shi M, Gu A, Tu H, Huang C, Wang H, Yu Z, Wang X, Cao L, Shu Y, Wang H, Yang R, Li X, Chang J, Hu Y, Shen P, Hu Y, Guo Z, Tao M, Zhang Y, Liu X, Sun Q, Zhang X, Jiang Z, Zhao J, Chen F, Yu H, Zhang W, Sun J, Li D, Zhou J, Han B, Wu YL. Comparing nanoparticle polymeric micellar paclitaxel and solvent-based paclitaxel as first-line treatment of advanced non-small-cell lung cancer: an open-label, randomized, multicenter, phase III trial. Ann Oncol. 2021 Jan;32(1):85-96. doi: 10.1016/j.annonc.2020.10.479. Epub 2020 Oct 29.

Related trials for Non-Small Cell Lung Cancer(NSCLC)

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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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.

Baohui Han principal investigator

Shanghai Chest Hospital

Yilong Wu principal investigator

Guangdong Provincial People's Hospital

Meiqi Shi principal investigator

Jiangsu Cancer Institute & Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 23 inclusion and 16 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Objective response rate (time frame: Baseline to measured PD (up to 36 months)). 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 NCT02667743, 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 17 Mar 2021.