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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Device: Tumor treating fields（EFE-P100）; Drug: Docetaxel injection

• Study Type: Interventional
• Enrollment (Anticipated): 348
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Zhou; Phone Number: 02165115006; Email: caicunzhou@yahoo.com.cn

Study Locations

• China
  • Shanghai, China
    • Shanghai Pulmonary Hospital
    • Contact: Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18 and ≤80, both sexes;
2. Expected survival time ≥3 months;
3. 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.
4. 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.
5. At least one measurable or evaluable lesion according to RECIST version 1.1;
6. ECOG 0-1;
7. Concomitant Adverse Event（AE） after previous treatment should return to normal level or Common Terminology Criteria for Adverse Events（CTCAE） grade 1;
8. Voluntarily sign informed consent.

Exclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Previous docetaxel therapy or docetaxel-containing combination therapy;
5. There are contraindications to docetaxel treatment or a known severe allergy to docetaxel;
6. 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;
7. 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;
8. 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);
9. 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;
10. If she had severe infection before the first treatment, the investigator judged that she was not suitable to participate in this study.
11. A history of human immunodeficiency virus (HIV) infection (known HIV1/2 antibody positive);
12. The presence of active hepatitis B, active hepatitis C, or other active infections that the investigator determines may affect the patient's treatment;
13. 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;
14. Symptomatic ascites, pleural effusion, pericardial effusion, etc., except those who are stable after clinical treatment (including therapeutic puncture);
15. Infection, ulceration and unhealed wound on the skin where the electrode is applied;
16. Currently participating in other antitumor therapy clinical trials;
17. Implantable electronic medical devices, such as pacemakers;
18. Chest and abdomen have implanted metal materials of medical instruments, such as bone nails;
19. Allergic to conductive hydrogels or medical adhesives;
20. Pregnant or trying to become pregnant or breastfeeding;
21. Poor compliance or other factors as judged by the investigator were not appropriate for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tumor treating fields combined with docetaxel injection; 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.	Device: Tumor treating fields（EFE-P100）; Device: Tumor treating fields（EFE-P100） Subjects will use EFE-P100 until disease progression or for a maximum of 24 months.; Drug: Docetaxel injection; Drug: Docetaxel injection Subjects will receive Docetaxel injection until disease progression or for a maximum of 24 months.
Active Comparator: docetaxel injection; Drug: docetaxel each cycle is 21 days，docetaxel will be administered intravenously，75 mg/m2 on the first day of each cycle.	Drug: Docetaxel injection; Drug: Docetaxel injection Subjects will receive Docetaxel injection until disease progression or for a maximum of 24 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.	Up to 2 years
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
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

Collaborators and Investigators

• Sponsor: Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
• Investigators: Principal Investigator: Zhou, MD

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2022
• Primary Completion (Anticipated): May 25, 2024
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Estimate): December 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Disease Progression; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: P100-NSCLC2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No