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

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.

Timeline

Start

2022-12-20

Primary completion

2024-05-25

Completion

2025-07-31

Drugs

Indications