Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Advanced Non-small Cell Lung Cancer (NSCLC)

Overview

About this study

The purpose of this study 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Vinicius Ernani, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

  • Low intensity, intermediate frequency, alternating electric fields (Tumor Treating Fields; TTFields) exhibit anti-mitotic activity in cancer cells. Promising preclinical data have led to a single arm phase I/II trial in NSCLC patients. Read More on PubMed
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CLS-20524004

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