Clinical Trials

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated April 26, 2023. Questions regarding updates should be directed to the study team contact.