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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
Phase 2, PHASE3 trial testing Tumor treating fields(EFE-P100) in Non-small Cell Lung Cancer (NSCLC) in 348 participants. Status unknown.
25 May 2024
Quick facts
| Lead sponsor | Jiangsu Healthy Life Innovation Medical Technology Co., Ltd |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 348 |
| Start date | 20 December 2022 |
| Primary completion | 25 May 2024 |
| Estimated completion | 31 July 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tumor treating fields(EFE-P100)
- Docetaxel injection — full drug profile →
Conditions studied
- Non-small Cell Lung Cancer (NSCLC) — all drugs for Non-small Cell Lung Cancer (NSCLC) →
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.
Verify or expand the search:
- PubMed search for NCT05661240
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Non-small Cell Lung Cancer (NSCLC)
Currently open trials in the same condition.
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- NCT07140016 — A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) · Phase 1 · recruiting
Other Jiangsu Healthy Life Innovation Medical Technology Co., Ltd trials
Trials by the same sponsor.
- NCT06716775 — Tumor Treating Fields (TTF) in Combination with Stereotactic Radiosurgery(SRS) for Brain Metastases from Non-small Cell · NA · not yet recruiting
- NCT06611345 — A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers · NA · recruiting
- NCT06353360 — TTField in Combination With Temozolomide and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma. · Phase 2 · unknown
- NCT05653453 — Clinical Study of Tumor Treating Fields Combined with Gemcitabine and Albumin-bound Paclitaxel in the First-line Treatme · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05661240 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jiangsu Healthy Life Innovation Medical Technology Co., Ltd
- Last refreshed: 22 December 2022
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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