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NCT05661240

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

Status unknown Phase 2, PHASE3 Last updated 22 December 2022
What this trial tests

Phase 2, PHASE3 trial testing Tumor treating fields(EFE-P100) in Non-small Cell Lung Cancer (NSCLC) in 348 participants. Status unknown.

Timeline
20 December 2022
Primary endpoint
25 May 2024
31 July 2025

Quick facts

Lead sponsorJiangsu Healthy Life Innovation Medical Technology Co., Ltd
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment348
Start date20 December 2022
Primary completion25 May 2024
Estimated completion31 July 2025
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Jiangsu Healthy Life Innovation Medical Technology Co., Ltd — full company profile →

Who can join

Adults 18 to 80, any sex, with Non-small Cell Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Non-small Cell Lung Cancer (NSCLC)

Currently open trials in the same condition.

Other Jiangsu Healthy Life Innovation Medical Technology Co., Ltd trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05661240.

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