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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: Clinical Trial Phase 2 study, sponsored by NovoCure.
NCT04892472 is a Phase 2 study that was terminated before completion, run by NovoCure. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS will be measured from the date of enrollment to date of progression (in months) based on RECIST 1.1 criteria. The analysis will include stratification by PD-L1 expression, TPS≥1-49% and TPS≥50%, as a secondary outcome.
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 |
Why NCT04892472 stopped before completion
NCT04892472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which NovoTTF-200T is the first listed.
NCT04892472 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04892472's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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