Ensayos clínicos

Inclusion Criteria:

• 18 years of age and older.
• Life expectancy of ≥ 3 months.
• New diagnosis of brain metastases from a histologically or cytologically confirmed primary or metastatic NSCLC tumor within 5 years of registration on the study. If the original histological proof of malignancy is greater than 5 years, then pathological confirmation is required (i.e., from extra-cranial or intracranial disease).
• Karnofsky performance status (KPS) ≥ 70
• 1 inoperable brain metastasis or 2- 10 brain lesions per screening MRI, confirmed by contrast enhanced MRI amenable to SRS according to the following criteria:
  • largest tumor volume < 10 cc;
  • longest tumor diameter < 3 cm;
  • Cumulative volume of all tumors ≤ 15 cc.
• At least one measurable lesion per RANO-BM (Response Assessment in Neuro-Oncology Brain Metastases) Criteria for brain metastasis.
• Patients must be receiving optimal therapy for their extracranial disease according to local practice at each center. Patients may continue on systemic therapy while receiving TTFields.
• Able to operate the NovoTTF-100M device independently or with the help of a caregiver.
• Clinical trials prior to enrollment are allowed, as long as no brain directed therapy was included (current treatment trials are exclusionary).

Exclusion Criteria:

• Patients who are known to have somatic tumor mutations in the following genes, for which targeted agents are available that directly affect the treatment of brain metastasis: Anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR), ROS-1 proto-oncogene, and proto-oncogene B-RAF.
• Patients who have a single, operable brain metastasis.
• Patients with significant edema leading to risk of brain herniation.
• Patients with midline shift > 10mm.
• Patients with intractable seizures.
• Leptomeningeal metastases.
• Recurrent brain metastases.
• Prior WBRT for newly diagnosed brain metastases.
• Severe comorbidities:
  • Clinically-significant inadequate hematological, hepatic and renal function, defined as: Neutrophil count < 1.5 x 10^9/L and platelet count < 100 x 10^9/L; bilirubin > 1.5 x upper limit of normal (ULN); aspartate transaminase (AST) and/or alanine aminotransferase (ALT) > 2.5 x ULN or > 5 x ULN if patient has documented liver metastases; and serum creatinine > 1.5 x ULN;
  • History of significant cardiovascular disease unless the disease is well controlled. Significant cardiac disease includes second/third degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation or dyspnea);
  • History of arrhythmia that is symptomatic or requires treatment. Patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial;
  • History of cerebrovascular accident (CVA) within 6 months prior to randomization or that is not stable;
  • Active infection or serious underlying medical condition that would impair the ability of the patient to received protocol therapy;
  • History of any psychiatric condition that might impair patient's ability to understand or comply with the requirements of the study or to provide consent.
• Implantable electronic medical devices in the brain.
• Known allergies to medical adhesives or hydrogel.
• Currently pregnant or breastfeeding.
• Concurrent brain directed therapy (beyond SRS and NovoTTF-100M as per protocol).

Eligibility last updated 2/14/22. Questions regarding updates should be directed to the study team contact.