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Phase Ⅱ/Ⅲ Clinical Study of Tumor Treating Fields (EFE-P100)Combined With Docetaxel in the Treatment of Stage IV Non-small Cell Lung Cancer Patients With Disease Progression After Platinum-based Chemotherapy and Anti-programmed Death 1(PD-1)/Programmed Cell Death-Ligand 1(PD-L1) Antibody Treatment

Primary Purpose

Non-small Cell Lung Cancer (NSCLC)

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tumor treating fields(EFE-P100)
Docetaxel injection
Sponsored by
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 and ≤80, both sexes; Expected survival time ≥3 months; Non-small cell lung cancer was confirmed histologically or cytologically and classified as stage IV NSCLC according to the American Joint Committee on Cancer(AJCC)of eighth edition. Imaging progression (according to RECIST V1.1 criteria) or clinical progression during previous anti-PD - (L) 1 antibody and platinum-containing therapy or after treatment; - Neoadjuvant or adjuvant therapy, such as disease recurrence or progression ≤6 months after the end of treatment, counted as first-line treatment; - Prior treatment with at least 2 cycles of anti-PD - (L) 1 antibody, allowed as a single agent or in combination with platinum-based chemotherapy. At least one measurable or evaluable lesion according to RECIST version 1.1; ECOG 0-1; Concomitant Adverse Event(AE) after previous treatment should return to normal level or Common Terminology Criteria for Adverse Events(CTCAE) grade 1; Voluntarily sign informed consent. Exclusion Criteria: Epidermal growth factor receptor(EGFR)-activating mutations or Anaplastic Lymphoma Kinase(ALK) fusion gene was positive; However, if squamous non-small cell lung cancer has not been tested before, it can no longer be tested and allowed to be enrolled. Untreated brain metastases, or with meningeal metastases, spinal cord compression, etc. Patients who had received previous treatment for brain metastases and were asymptomatic if they had been stable for at least 4 weeks on imaging before randomization and had stopped systemic hormone therapy (dose >10mg/ day prednisone or other equivalent hormone) for more than 2 weeks were eligible. Severe bone injury due to bone metastases, including severe bone pain that is poorly controlled, pathologic fractures of major sites that have occurred within the last 6 months or are expected to occur in the near future. Previous docetaxel therapy or docetaxel-containing combination therapy; There are contraindications to docetaxel treatment or a known severe allergy to docetaxel; A history of diagnosis of a tumor other than small-cell lung cancer and antitumor therapy within 5 years prior to enrollment, excluding treated stage I prostate cancer, cervical or uterine cancer in situ, breast cancer in situ, and non-melanoma skin cancer; Abnormal bone marrow, heart, liver and kidney function: A. Neutrophil count <1.5×109/L, platelet count <100×109/L, hemoglobin <90 g/L; TBiL> upper normal value (ULN); AST and/or ALT>2.5×ULN; ALP>2.5×ULN (>5×ULN if bone metastases are present); C. Serum creatinine >1.5×ULN; Creatinine clearance rate <50 mL/min; A history of severe cardiovascular disease, including second/third degree heart block; Severe ischemic heart disease; Poor control of hypertension; New York Heart Association (NYHA) class II or worse congestive heart failure (mild physical activity limitation; Comfortable at rest, but normal activities can cause fatigue, palpitations, or difficulty breathing); Patients who required systemic corticosteroid (other corticosteroid at a dose of more than 10mg prednisone per day or an equivalent physiologic dose) or other immunosuppressive agents within 14 days prior to enrollment or during the study period were eligible for enrollment if: A. The use of topical or inhaled glucocorticoids is permitted; B. Allow short-term (≤7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases; If she had severe infection before the first treatment, the investigator judged that she was not suitable to participate in this study. A history of human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive); The presence of active hepatitis B, active hepatitis C, or other active infections that the investigator determines may affect the patient's treatment; There is a definite history of neurological or psychiatric disorders (e.g., epilepsy, dementia) or drug use or alcohol abuse within the last year that may affect trial compliance; Symptomatic ascites, pleural effusion, pericardial effusion, etc., except those who are stable after clinical treatment (including therapeutic puncture); Infection, ulceration and unhealed wound on the skin where the electrode is applied; Currently participating in other antitumor therapy clinical trials; Implantable electronic medical devices, such as pacemakers; Chest and abdomen have implanted metal materials of medical instruments, such as bone nails; Allergic to conductive hydrogels or medical adhesives; Pregnant or trying to become pregnant or breastfeeding; Poor compliance or other factors as judged by the investigator were not appropriate for the study.

Sites / Locations

  • Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tumor treating fields combined with docetaxel injection

docetaxel injection

Arm Description

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.

Drug: docetaxel each cycle is 21 days,docetaxel will be administered intravenously,75 mg/m2 on the first day of each cycle.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Overall survival (OS)
From date of enrollment until the date of death from any cause
12-month OS rate
12-month Overall survival rate
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

Full Information

First Posted
December 7, 2022
Last Updated
December 21, 2022
Sponsor
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05661240
Brief Title
Phase Ⅱ/Ⅲ Clinical Study of Tumor Treating Fields (EFE-P100)Combined With Docetaxel in the Treatment of Stage IV Non-small Cell Lung Cancer Patients With Disease Progression After Platinum-based Chemotherapy and Anti-programmed Death 1(PD-1)/Programmed Cell Death-Ligand 1(PD-L1) Antibody Treatment
Official Title
Phase Ⅱ/Ⅲ Clinical Study of Tumor Treating Fields(EFE-P100) Combined With Docetaxel in the Treatment of Stage IV Non-small Cell Lung Cancer Patients With Disease Progression After Platinum-based Chemotherapy and Anti-programmed Death 1(PD-1)/Programmed Cell Death-Ligand 1(PD-L1) Antibody Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 20, 2022 (Anticipated)
Primary Completion Date
May 25, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer (NSCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tumor treating fields combined with docetaxel injection
Arm Type
Experimental
Arm Description
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.
Arm Title
docetaxel injection
Arm Type
Active Comparator
Arm Description
Drug: docetaxel each cycle is 21 days,docetaxel will be administered intravenously,75 mg/m2 on the first day of each cycle.
Intervention Type
Device
Intervention Name(s)
Tumor treating fields(EFE-P100)
Intervention Description
Device: Tumor treating fields(EFE-P100) Subjects will use EFE-P100 until disease progression or for a maximum of 24 months.
Intervention Type
Drug
Intervention Name(s)
Docetaxel injection
Intervention Description
Drug: Docetaxel injection Subjects will receive Docetaxel injection until disease progression or for a maximum of 24 months.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Number of participants with adverse events (AEs)
Description
Will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with study treatments
Time Frame
The whole study period,an average of 2 year
Title
Objective response rate (ORR)
Description
ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
Time Frame
Up to 2 years
Title
Overall survival (OS)
Description
From date of enrollment until the date of death from any cause
Time Frame
up to 12 months after the last study treatment
Title
12-month OS rate
Description
12-month Overall survival rate
Time Frame
12 months
Title
Progression Free Survival rate at 6 months
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 and ≤80, both sexes; Expected survival time ≥3 months; Non-small cell lung cancer was confirmed histologically or cytologically and classified as stage IV NSCLC according to the American Joint Committee on Cancer(AJCC)of eighth edition. Imaging progression (according to RECIST V1.1 criteria) or clinical progression during previous anti-PD - (L) 1 antibody and platinum-containing therapy or after treatment; - Neoadjuvant or adjuvant therapy, such as disease recurrence or progression ≤6 months after the end of treatment, counted as first-line treatment; - Prior treatment with at least 2 cycles of anti-PD - (L) 1 antibody, allowed as a single agent or in combination with platinum-based chemotherapy. At least one measurable or evaluable lesion according to RECIST version 1.1; ECOG 0-1; Concomitant Adverse Event(AE) after previous treatment should return to normal level or Common Terminology Criteria for Adverse Events(CTCAE) grade 1; Voluntarily sign informed consent. Exclusion Criteria: Epidermal growth factor receptor(EGFR)-activating mutations or Anaplastic Lymphoma Kinase(ALK) fusion gene was positive; However, if squamous non-small cell lung cancer has not been tested before, it can no longer be tested and allowed to be enrolled. Untreated brain metastases, or with meningeal metastases, spinal cord compression, etc. Patients who had received previous treatment for brain metastases and were asymptomatic if they had been stable for at least 4 weeks on imaging before randomization and had stopped systemic hormone therapy (dose >10mg/ day prednisone or other equivalent hormone) for more than 2 weeks were eligible. Severe bone injury due to bone metastases, including severe bone pain that is poorly controlled, pathologic fractures of major sites that have occurred within the last 6 months or are expected to occur in the near future. Previous docetaxel therapy or docetaxel-containing combination therapy; There are contraindications to docetaxel treatment or a known severe allergy to docetaxel; A history of diagnosis of a tumor other than small-cell lung cancer and antitumor therapy within 5 years prior to enrollment, excluding treated stage I prostate cancer, cervical or uterine cancer in situ, breast cancer in situ, and non-melanoma skin cancer; Abnormal bone marrow, heart, liver and kidney function: A. Neutrophil count <1.5×109/L, platelet count <100×109/L, hemoglobin <90 g/L; TBiL> upper normal value (ULN); AST and/or ALT>2.5×ULN; ALP>2.5×ULN (>5×ULN if bone metastases are present); C. Serum creatinine >1.5×ULN; Creatinine clearance rate <50 mL/min; A history of severe cardiovascular disease, including second/third degree heart block; Severe ischemic heart disease; Poor control of hypertension; New York Heart Association (NYHA) class II or worse congestive heart failure (mild physical activity limitation; Comfortable at rest, but normal activities can cause fatigue, palpitations, or difficulty breathing); Patients who required systemic corticosteroid (other corticosteroid at a dose of more than 10mg prednisone per day or an equivalent physiologic dose) or other immunosuppressive agents within 14 days prior to enrollment or during the study period were eligible for enrollment if: A. The use of topical or inhaled glucocorticoids is permitted; B. Allow short-term (≤7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases; If she had severe infection before the first treatment, the investigator judged that she was not suitable to participate in this study. A history of human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive); The presence of active hepatitis B, active hepatitis C, or other active infections that the investigator determines may affect the patient's treatment; There is a definite history of neurological or psychiatric disorders (e.g., epilepsy, dementia) or drug use or alcohol abuse within the last year that may affect trial compliance; Symptomatic ascites, pleural effusion, pericardial effusion, etc., except those who are stable after clinical treatment (including therapeutic puncture); Infection, ulceration and unhealed wound on the skin where the electrode is applied; Currently participating in other antitumor therapy clinical trials; Implantable electronic medical devices, such as pacemakers; Chest and abdomen have implanted metal materials of medical instruments, such as bone nails; Allergic to conductive hydrogels or medical adhesives; Pregnant or trying to become pregnant or breastfeeding; Poor compliance or other factors as judged by the investigator were not appropriate for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhou
Phone
02165115006
Email
caicunzhou@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhou
Organizational Affiliation
MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhou

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Phase Ⅱ/Ⅲ Clinical Study of Tumor Treating Fields (EFE-P100)Combined With Docetaxel in the Treatment of Stage IV Non-small Cell Lung Cancer Patients With Disease Progression After Platinum-based Chemotherapy and Anti-programmed Death 1(PD-1)/Programmed Cell Death-Ligand 1(PD-L1) Antibody Treatment

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