Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Advanced Non-small Cell Lung Cancer (NSCLC)
Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Scottsdale/Phoenix, Arizona: 21-007447
NCT ID: NCT04892472
Sponsor Protocol Number: EF-36/KEYNOTE B36
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.
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.
- 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.
- 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
Mayo Clinic principal investigator
Vinicius Ernani, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office
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.
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