MedTrace Logo

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

NCT05661240 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2022-12-22

No results posted yet for this study

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.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

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.

Sponsors & Collaborators

  • Jiangsu Healthy Life Innovation Medical Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhou · MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-20
Primary Completion
2024-05-25
Completion
2025-07-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05661240 on ClinicalTrials.gov