Status:
TERMINATED
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
Lead Sponsor:
NovoCure GmbH
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
22+ years
Phase:
PHASE2
Brief 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 fo...
Detailed Description
TTFields have demonstrated significant activity in vitro and in NSCLC pre-clinical models, both as a single modality treatment and concomitant with chemotherapies and PD-1 inhibitors. TTFields have de...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
July 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04892472
Start Date
July 12 2021
End Date
January 10 2025
Last Update
April 23 2025
Active Locations (24)
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1
Central Alabama Research
Birmingham, Alabama, United States, 35209
2
Palo Verde Cancer Specialists
Glendale, Arizona, United States, 85304
3
Mayo Clinic
Phoenix, Arizona, United States, 85054
4
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806