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NCT04892472 · ClinicalTrials.gov registry record · Phase 2
EF-36/Keynote B36: A Pilot, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 2 study, sponsored by NovoCure.
- Terminated
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT04892472 is a Phase 2 study that was terminated before completion, run by NovoCure. The registered enrollment target is 15 participants.
The verdict
NCT04892472, a Phase 2 study, was terminated before completion, sponsored by NovoCure.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, open-label study of Tumor Treating Fields (TTFields) at 150 kHz to the thorax using the NovoTTF-200T System with IV pembrolizumab in subjects previously untreated for advanced or metastatic, PD-L1 positive non-small cell lung cancer (NSCLC). The primary objective is to evaluate the progression-free survival (PFS) by RECIST 1.1 in subjects with TPS ≥1 percent, 1L metastatic/current advanced NSCLC treated with TTFields concomitant with pembrolizumab compared to those treated with pembrolizumab alone. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
Interventions
- DEVICE NovoTTF-200T
- DRUG Pembrolizumab (MK-3475) 200 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-07-12 |
| Est. Completion | 2025-01-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04892472
The ClinicalTrials.gov registry entry for NCT04892472 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NovoCure, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which NovoTTF-200T is the first listed.
NCT04892472 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04892472 about?
NCT04892472 is a clinical study titled "EF-36/Keynote B36: A Pilot, Randomized, Open-label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for First Line Treatment of Advanced or Metastatic Non-small Cell Lung Cancer". This is a multicenter, randomized, open-label study of Tumor Treating Fields (TTFields) at 150 kHz to the thorax using the NovoTTF-200T System with IV pembrolizumab in subjects previously untreated for advanced or metastatic, PD-L1 positive non-small cell lung cancer (NSCLC). The primary objective i...
What is the current status of trial NCT04892472?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2021-07-12. Estimated completion is 2025-01-10.
What interventions are being tested in trial NCT04892472?
The interventions under investigation include: NovoTTF-200T (DEVICE), Pembrolizumab (MK-3475) 200 mg (DRUG).
Who is sponsoring clinical trial NCT04892472?
This trial is sponsored by NovoCure, which has 11 total clinical trials registered on ClinicalTrials.gov.
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