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
Megadott ok: Phase 2 study terminated due to insufficient enrollment and was not based on safety concerns. Novocure is enrolling a new Phase 3 study of TTFields as a first line treatment for advanced/metastatic NSCLC (NCT06216301).
Key facts
- Where
- Birmingham, Canton, Charlotte, Chicago, Colorado Springs, Dallas, Edgewood, Elmira, Farmington Hills, Fort Wayne, Glendale, Houston, Indianapolis, Knoxville, Lake City, Las Vegas, Lexington, Lincoln, Long Beach, Miami, Phoenix, Sterling Heights és Wynnewood, Egyesült ÁllamokSee the 24 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- Central Alabama ResearchBirmingham, Egyesült ÁllamokNo longer taking part
- Aultman HospitalCanton, Egyesült ÁllamokNo longer taking part
- Gabrail Cancer & Research CenterCanton, Egyesült ÁllamokNo longer taking part
- Oncology Specialists of CharlotteCharlotte, Egyesült ÁllamokNo longer taking part
- University of Illinois Hospital and Health Sciences SystemChicago, Egyesült ÁllamokNo longer taking part
- UCHealth Memorial HospitalColorado Springs, Egyesült ÁllamokNo longer taking part
- Texas Oncology Sammons Cancer CenterDallas, Egyesült ÁllamokNo longer taking part
- Saint Elizabeth HealthcareEdgewood, Egyesült ÁllamokNo longer taking part
- Arnot Ogen Medical Center - Falck Cancer CenterElmira, Egyesült ÁllamokNo longer taking part
- Michigan Center of Medical ResearchFarmington Hills, Egyesült ÁllamokNo longer taking part
- Parkview Research CenterFort Wayne, Egyesült ÁllamokNo longer taking part
- Palo Verde Cancer SpecialistsGlendale, Egyesült ÁllamokNo longer taking part
- The University of Texas MD Anderson Cancer CenterHouston, Egyesült ÁllamokNo longer taking part
- Franciscan St. Francis Health IndianapolisIndianapolis, Egyesült ÁllamokNo longer taking part
- Tennessee Cancer SpecialistsKnoxville, Egyesült ÁllamokNo longer taking part
- Cancer Care of North FloridaLake City, Egyesült ÁllamokNo longer taking part
- OptumCare Cancer CareLas Vegas, Egyesült ÁllamokNo longer taking part
- Baptist Health Oncology ResearchLexington, Egyesült ÁllamokNo longer taking part
- Cancer Partners of NebraskaLincoln, Egyesült ÁllamokNo longer taking part
- Long Beach Memorial Medical CenterLong Beach, Egyesült ÁllamokNo longer taking part
- Miami Cancer Insititute - Baptist Health South FloridaMiami, Egyesült ÁllamokNo longer taking part
- Mayo ClinicPhoenix, Egyesült ÁllamokNo longer taking part
- Cancer and Leukemia CenterSterling Heights, Egyesült ÁllamokNo longer taking part
- Lankenau Medical CenterWynnewood, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- NovoCure GmbH
- Trial code
- NCT04892472
- Record updated
- 2025. április 23.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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); 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; Has an EGFR sensitizing mutation and/ or ALK translocation; Has known active or untreated CNS metastases and/or carcinomatous meningitis; Being unable to operate the NovoTTF-200T device independently or with the help of a caregiver; Pregnancy or breastfeeding.