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

EF- 36

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.

2021-07-12

2024-07-01

2026-12-01

Recruiting

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2023-10-06