Overview

Effect of Tumor Treating Fields (TTFields) (150 kHz) Concomitant With Pembrolizumab for Treatment of Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC)

Status:
Recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
NovoCure GmbH
Collaborator:
Merck Sharp & Dohme LLC
Treatments:
Pembrolizumab