NSCLC Lung cancer
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: 1. a. >=22 years of age in the USA b. >=18 years of age outside of the USA. 2. Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the American Joint Committee on Cancer [AJCC] criteria) non-squamous or squamous NSCLC. 3. Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1. 4. Have not received prior systemic treatment for their metastatic NSCLC. Subjects who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease are eligible if the therapy was completed at least 12 months prior to the development of metastatic disease. 5. Have provided tumor tissue from locations not radiated prior to biopsy; formalin - fixed specimens after the subject has been diagnosed with metastatic disease will be preferred for determination of PD-L1 status assessed locally prior to randomization. 6. ECOG Performance Status (PS) of 0-1. 7. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to randomization: o ANC >= 1.5 x 109/L (1500/µL) without granulocyte colony-stimulating factor support o Platelet count >= 100 x 109/L (75,000/µL) without transfusion o Hemoglobin >= 90 g/L (9 g/dL) Subjects may be transfused to meet this criterion. o AST, ALT
Exclusion criteria
Exclusion criteria: 1. Mixed small cell and NSCLC histology. 2. EGFR sensitizing mutation and/or ALK translocation, and/or ROS1 and/or RET targetable gene rearrangement, and/or METex14 skipping mutation, and/or NTRK1/2 gene fusion directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available. Source documentation of the applicable driver mutations should be available at the site. Note: For subjects enrolled who are known to have a tumor of predominantly squamous histology, molecular testing for EGFR mutation, ALK translocation and ROS1 and/or RET gene rearrangements, and/or METex14 skipping mutation, and/or NTRK1/2 gene fusion will not be required as this is not standard of care and is not part of current diagnostic guidelines. 3. Has received systemic therapy for metastatic disease. 4. Had major surgery 30 Gy within 6 months of randomization. 6. Has received prior radiotherapy within 2 weeks of randomization. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<=2 weeks of radiotherapy) to non-CNS disease. 7. Is expected to require any other form of antineoplastic therapy while on study. 8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded. 9. Has untreated or symptomatic Central Nervous System (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they were treated before randomization and are clinically stable and without requirement of steroid treatment for at least 3 days prior to randomization. 10. 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. 11. 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 randomization. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study. 12. Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms in the 12 months prior to randomization. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD-L1, IL-2R, GITR. 13. Participation in another clinical study with an investigational agent or device during the 4 weeks prior to randomization. Note: Participants who have entered the follow-up phase of an inve
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Overall survival (OS), in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to OS of those treated with pembrolizumab and platinum-based chemotherapy alone. • Progression-Free Survival (PFS), per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed by Blinded Independent Central Review (BICR), in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy compared to PFS of those treated with pembrolizumab and platinum-based chemotherapy alone. | — |
Secondary
| Measure | Time frame |
|---|---|
| • PFS per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to histology. • OS in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to histology. • PFS per RECIST v1.1 as assessed by BICR, in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to PD-L1 Tumor Proportion Score (TPS). • OS in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone according to PD-L1 TPS. • PFS per RECIST v1.1 as assessed by BICR at 6 (PFS6), 12 (PFS12), 24 (PFS24), and 36 (PFS36) months in subjects treated with TTFields concomitant with pembrolizumab and platinum-based chemotherapy and of those treated with pembrolizumab and platinum-based chemotherapy alone. | — |
Countries
Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Israel, Japan, Mexico, Netherlands, Serbia, Singapore, Slovakia, South Korea, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactS Gumy
Novocure GmbH
Outcome results
None listed