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EF-36/Keynote: A pilot, single arm, open-label study of Tumor Treating Fields (TTFields, 150 kHz) concomitant with pembrolizumab for first line treatment of advanced or metastatic intrathoracic non-small cell lung cancer
Description
This is a multicenter, single arm, open-label study of Tumor Treating Fields (TTFields) at 150 kHz to the thorax using the NovoTTF-200T System concomitant with IV pembrolizumab in subjects previously untreated for their advanced or metastatic intrathoracic, PD-L1 positive non-small cell lung cancer (NSCLC). The primary objective is to evaluate the objective response rate (ORR) by RECIST 1.1 in subjects with TPS ≥1 percent.
The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
Learn more at clinicaltrials.gov
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, newly diagnosed unresectable stage III or metastatic (M1a) intrathoracic NSCLC without EGFR sensitizing mutation or ALK translocation
- Age ≥ 22 years
- Have a PD-L1 positive (TPS≥1%) tumor by local laboratory assessment
- Measurable disease by RECIST 1.1
- ECOG performance status of 0 to 1
- Have not received prior systemic treatments for NSCLC.
- Life expectancy of at least 3 months
- Able to operate the NovoTTF-200T system
Exclusion
- Has an extrathoracic metastasis (i.e. M component is M1b or M1c)
- Has an EGFR sensitizing mutation and/ or ALK translocation
- If Stage III, can be treated with curative intent with either surgical resection and/or chemoradiation
- Has received prior systemic anti-cancer therapy or prior radiotherapy for NSCLC (palliative radiotherapy is allowed)
- Being unable to operate the NovoTTF-200T device independently or with the help of a caregiver
- Pregnancy or breastfeeding
- Significant illnesses not associated with the primary disease
- Implanted electronic devices (e.g. pacemaker) in the upper torso