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The tumor treating fields(EFE-P100)generates alternating electric field during operation, and the tumor treating fields(EFE-P100)has a specific frequency and a specific field intensity. The tumor treating fields(EFE-P100)patch acts on the corresponding part of the patient and prevents the mitosis of tumor cells. This study was divided into two phases including phase II and phase III clinical trials. The main purpose of phase II clinical trial is to evaluate the safety of tumor treating fields(EFE-P100) combined with docetaxel injection in the second-line treatment of stage IV non-small Cell Lung Cancer (NSCLC) patients who failed after platinum-containing chemotherapy and anti-programmed Death 1(PD-1)/Programmed Cell Death-Ligand 1(PD-L1) antibody treatment. The main purpose of phase III clinical trial is to compare the efficacy of tumor treating fields(EFE-P100) combined with docetaxel injection and docetaxel injection alone in the second-line treatment of stage IV non-small cell lung cancer (NSCLC) patients who failed after platinum-containing chemotherapy and anti-programmed Death 1(PD-1)/Programmed Cell Death-Ligand 1(PD-L1) antibody treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tumor treating fields combined with docetaxel injection | Experimental | Medical device:Tumor treating fields(EFE-P100) Tumor treating fields(EFE-P100)will be used each day. Drug: docetaxel each cycle is 21 days,docetaxel will be administered intravenously,75 mg/m2 on the first day of each cycle. |
|
| docetaxel injection | Active Comparator | Drug: docetaxel each cycle is 21 days,docetaxel will be administered intravenously,75 mg/m2 on the first day of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor treating fields(EFE-P100) | Device | Device: Tumor treating fields(EFE-P100) Subjects will use EFE-P100 until disease progression or for a maximum of 24 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival is defined as the time from the start of treatment with Tumor Treating Fields(EFE-P100) and Docetaxel until the first documentation of disease progression or death due to any cause, whichever occurs first | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments | The whole study period,an average of 2 year |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhou | Contact | 02165115006 | caicunzhou@yahoo.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhou | MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | China |
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| Docetaxel injection | Drug | Drug: Docetaxel injection Subjects will receive Docetaxel injection until disease progression or for a maximum of 24 months. |
|
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1. |
| Up to 2 years |
| Overall survival (OS) | From date of enrollment until the date of death from any cause | up to 12 months after the last study treatment |
| 12-month OS rate | 12-month Overall survival rate | 12 months |
| Progression Free Survival rate at 6 months | The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RECIST 1.1 criteria following the time of enrollment | 6 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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