longkanker Lung cancer NSCLC
Conditions
Interventions
Mild to moderate dermatitis is the most common adverse event seen in subjects
treated with the NovoTTF-200T Treatment Kit. In order
to prevent and treat this condition, prophylaxis and intervention
Sponsors
Novocure GmbH
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Individuals must meet all of the following inclusion criteria in order to be eligible to be enrolled and participate in the study: 1. Signed informed consent form. a. Be >=22 years of age on the day of providing informed consent in the USA. b. Be >=18 years of age on the day of providing informed consent outside of the USA. 2. Life expectancy of > 3 months. 3. Histologically or cytologically confirmed diagnosis of NSCLC. 4. Documented positive tumor PD-L1 expression (TPS>=1%). 5. ECOG Score of 0-1. 6. Diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease. Subjects should not receive any systemic therapy after PD-1/PD-L1 Inhibitor + platinum failure before enrollment into the study. Maintenance therapy after platinum-based therapy and prior to progression is allowed. Sequence or combination of PD-1/PD-L1 inhibitor and platinum-based therapy is acceptable. 7. Subjects must have received one line of PD-1/PD-L1 inhibitor therapy for advanced or metastatic NSCLC. PD-1/PD-L1 inhibitor may have been given alone or in combination with other therapy. 8. Subjects who received PD-1/PD-L1 inhibitor for advanced disease, must have had a best response on PD-1/PD-L1 inhibitor of stable disease, partial response or complete response (in the opinion of the treating physician). 9. Subjects must have experienced disease progression (in the opinion of the treating physician) more than (>) 84 days following cycle 1 day 1 of their most recent PD-1/PD-L1 inhibitor therapy. Patients whose most recent line of therapy was PD-1/PD-L1 inhibitor monotherapy must have also experienced disease progression during or after prior platinum-based therapy. 10. Subject must have a CT with IV contrast or MRI with IV gadolinium scan of the brain to evaluate for central nervous system (CNS) disease within 28 days prior to study enrollment. 11. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to study enrollment: I. ANC >= 1.5 x 109/L (1,500/µL) without granulocyte colony-stimulating factor support II. Platelet count >= 100 x 109/L (100,000/µL) without transfusion III. Hemoglobin >= 90 g/L (9 g/dL) Subjects may be transfused to meet this criterion. IV. AST, ALT = 15 mL/min For subjects not receiving therapeutic anticoagulation: INR or aPTT <= 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants). 12. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: a. Not a woman of childbearing potential (WOCBP) b. A WOCBP who agrees to use two adequate barrier methods or a barrier method plus a hormonal method during the treatment period and for at least 120 days after the last dose of study therapy. Such methods of contraception, or true abstinence from heterosexual activity, when this is in line with the preferred and usual lifestyle of the subject, are required (periodic abstinence, e.g., calendar, ovulation, symptothermal, post-ovulation met
Exclusion criteria
Exclusion criteria: All individuals meeting any of the following exclusion criteria will be excluded from study enrollment and participation: 1. Mixed small cell and NSCLC histology. 2. Subject must not have leptomeningeal disease or spinal cord compression. 3. Subject must not have brain metastases unless: (1) metastases have been locally treated and have remained clinically controlled and asymptomatic for at least 14 days following treatment, and prior to study enrollment, AND (2) subject has no residual neurological dysfunction and has been off corticosteroids for at least seven days prior to study enrollment. 4. Contra-indication for PD-1/PD-L1 inhibitor therapy. 5. Subjects must not have received more than one line of PD-1/PD-L1 inhibitor for advanced disease. 6. Subjects with a known sensitizing mutation for which an Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), are excluded unless previously received at least one of the approved therapy(ies). Prior targeted therapy for subjects with targetable alterations is allowed if all other eligibility criteria are also met. 7. Subjects with more than (>) 2 lines of therapy in the advanced setting. 8. Had major surgery 30 Gy within 6 months before the first dose of study treatment. 10. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. For example: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ), or similar cancers that have undergone potentially curative therapy are not excluded. 11. Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. 12. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior study enrollment. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. 13. Significant comorbidity which is expected to affect the subject*s prognosis or ability to receive the study therapy: a. 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). b. History of arrhythmia that is symptomatic or requires treatment. Subjects with atrial fibrillation or flutter controlled by medication are not excluded from participation in the study. c. Any serio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) in subjects treated with TTFields concomitant with pembrolizumab compared to OS of subjects who were treated with docetaxel alone in the LUNAR/ EF-24 study. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in subjects treated with TTFields concomitant with pembrolizumab compared to PFS of subjects who were treated with docetaxel alone in the LUNAR/ EF-24 study. • OS in subjects treated with TTFields concomitant with pembrolizumab according to PD-L1 Tumor Proportion Score (TPS). • PFS in subjects treated with TTFields concomitant with pembrolizumab according to PD-L1 TPS. • OS in subjects treated with TTFields concomitant with pembrolizumab according to histology. • PFS in subjects treated with TTFields concomitant with pembrolizumab according to histology. • Relationship between OS and PFS, and NovoTTF-200T average monthly usage in subjects treated with TTFields concomitant with pembrolizumab • Safety profile of TTFields concomitant with pembrolizumab | — |
Countries
Netherlands
Outcome results
None listed