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EF-36/Keynote B36: A pilot, randomized, open-label study of Tumor Treating Fields (TTFields, 150 kHz) concomitant with pembrolizumab for first line treatment of advanced or metastatic non-small cell lung cancer

Primary Outcome Measures : Objective Response Rate (ORR) [ Time Frame: 24 months ] ORR will be measured from the date of enrollment to date of progression (in months) based on RECIST 1.1 criteria. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent as a Secondary Outcome Secondary Outcome Measures : Overall survival (OS) [ Time Frame: 24 months ] Survival will be measured from date of enrollment until date of death. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent Progression Free Survival (PFS) [ Time Frame: 24 months ] The analysis will be estimated proportions of patients who are progression-free based on the RECIST 1.1 criteria following the time of enrollment. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent Progression Free Survival at 6 months (PFS6) [ Time Frame: 6 months ] The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RECIST 1.1 criteria following the time of enrollment 1-year survival rates [ Time Frame: 12 months ] The analyses will be performed based on estimated proportions of patients who are alive at one year following enrollment Duration of response (DOR) [ Time Frame: 24 months ] The analysis will be defined as the time from response to progression/death (P/D) based on RECIST 1.1 criteria Disease control rate (DCR) [ Time Frame: 24 months ] Will be defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response (CR), partial response (PR), and stable disease (SD) by RECIST 1.1 Safety and Tolerability: adverse events (AEs) [ Time Frame: 24 months ] Will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with TTFields concomitant with pembrolizumab, as well as their association with study treatments

Primary Outcome Measures : Objective Response Rate (ORR) [ Time Frame: 24 months ] ORR will be measured from the date of enrollment to date of progression (in months) based on RECIST 1.1 criteria. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent as a Secondary Outcome Secondary Outcome Measures : Overall survival (OS) [ Time Frame: 24 months ] Survival will be measured from date of enrollment until date of death. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent Progression Free Survival (PFS) [ Time Frame: 24 months ] The analysis will be estimated proportions of patients who are progression-free based on the RECIST 1.1 criteria following the time of enrollment. The analysis will include patients with PD-L1 expression TPS≥1-49 percent and TPS≥50 percent Progression Free Survival at 6 months (PFS6) [ Time Frame: 6 months ] The analysis will be estimated proportions of patients who are progression-free at 6 months based on the RECIST 1.1 criteria following the time of enrollment 1-year survival rates [ Time Frame: 12 months ] The analyses will be performed based on estimated proportions of patients who are alive at one year following enrollment Duration of response (DOR) [ Time Frame: 24 months ] The analysis will be defined as the time from response to progression/death (P/D) based on RECIST 1.1 criteria Disease control rate (DCR) [ Time Frame: 24 months ] Will be defined as the percentage of patients with advanced or metastatic cancer who have achieved complete response (CR), partial response (PR), and stable disease (SD) by RECIST 1.1 Safety and Tolerability: adverse events (AEs) [ Time Frame: 24 months ] Will be defined as the incidence, frequency and severity of adverse events (AEs) noted in patients treated with TTFields concomitant with pembrolizumab, as well as their association with study treatments