TerminatedPhase 2NCT04892472

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 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.

Checked against the public recordLast updated Apr 23, 2025 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 2
U.S. locations24
SponsorNovoCure GmbH
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
NovoCure GmbH
Interventions being studied
Device: NovoTTF-200T; Drug: Pembrolizumab (MK-3475) 200 mg
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of stage III or metastatic NSCLC without EGFR sensitizing mutation or ALK translocation * Age ≥ 22 years * Have a PD-L1 positive (TPS≥1%) tumor by local laboratory assessment * Have evaluable (measureable or non-measureable) disease in thorax per RECIST 1.1 * ECOG performance status of 0 to 1 * Have not received prior treatments for metastatic or current advanced NSCLC. Palliative treatment is allowed and subjects who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease are eligible if therapy completed at least 12 months prior to the development of metastatic or current advanced disease. * Life expectancy of at least 3 months * Able to operate the NovoTTF-200T device Exclusion Criteria: * Has known active or untreated CNS metastases and/or carcinomatous meningitis * Has an EGFR sensitizing mutation and/ or ALK translocation * Can be treated with curative intent with either surgical resection and/or chemoradiation * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or an agent directed to another stimulatory or co-inhibitory T cell receptor within the past 12 months * Has received prior systemic anti-cancer therapy for metastatic or current advanced NSCLC (palliative radiotherapy is allowed) * Being unable to operate the NovoTTF-200T device independently or with the help of a caregiver * Pregnancy or breastfeeding * Received live vaccine in the past 30 days or had major surgery in the last 3 weeks * Is expected to require any other form of systemic or localized antineoplastic therapy while on study

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Central Alabama ResearchBirmingham, Alabama
  • Palo Verde Cancer SpecialistsGlendale, Arizona
  • Mayo ClinicPhoenix, Arizona
  • Long Beach Memorial Medical CenterLong Beach, California
  • UCHealth Memorial HospitalColorado Springs, Colorado
  • Cancer Care of North FloridaLake City, Florida
  • Miami Cancer Insititute - Baptist Health South FloridaMiami, Florida
  • University of Illinois Hospital and Health Sciences SystemChicago, Illinois
  • Parkview Research CenterFort Wayne, Indiana
  • Franciscan St. Francis Health IndianapolisIndianapolis, Indiana
  • Saint Elizabeth HealthcareEdgewood, Kentucky
  • Baptist Health Oncology ResearchLexington, Kentucky

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 23, 2025. Always confirm current availability with the study team.

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