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

NCT02667743 | Unknown Phase 3

• 1 other identifier: PM-03-2015
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 3

Brief 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 EL(polyoxyethylenated castor oil) In combination with Cisplatin in the way of an open-label, randomized controlled clinical trial. 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)

Keywords

NSCLC; Paclitaxel Micelles for Injection

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline to measured PD (up to 36 months)

Secondary Outcomes (5)

• Progression-Free-Survival

  Randomization to measured PD or date of death from any cause (up to 36 months)

• Overall survival

  Randomization to date of death from any cause (up to 36 months)

• Incidence of Adverse Events，Serious Adverse Events.

  up to 36 months

• Incidence of bone marrow suppression.

  up to 36 months

• The number of patients with dose adjustment.

  up to 36 months

Study Arms (2)

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.

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.

Drug: Paclitaxel Injection; Drug: Cisplatin

Interventions

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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;
• 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:

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Shanghai Yizhong Pharmaceutical Co., Ltd.: lead

Study Sites (3)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Jiangsu Cancer Hospital

Nanjing, Zhejiang, 210009, China

Location

Related Publications (1)

• 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.

  PMID: 33130217 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Injections; Paclitaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Baohui Han

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Yilong Wu

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Meiqi Shi

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 29, 2016
• Study Start: May 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: December 1, 2021
• Last Updated: March 17, 2021

Record last verified: 2020-03

Locations

CN (3)