Tomivosertib With Pembrolizumab In Subjects with NSCLC (Kickstart)
1L metastatic NSCLC with PD-L1 ≥ 1%
Tomivosertib (eFT508) is a novel small-molecule inhibitor of MNK that delays T cell exhaustion/dysfunction and is being developed in combination with pembrolizumab in 1L NSCLC patients with PD-L1 ≥ 1%.
Kickstart is a double-blind, randomized, multi-center Phase 2b clinical trial. One cohort will enroll patients with PD-L1 ≥1% NSCLC who have initiated frontline therapy with pembrolizumab combined with platinum-based chemotherapy. Another cohort includes patients with PD-L1 ≥ 50% in the frontline metastatic NSCLC setting. Patients in both cohorts will be randomized 1:1 to standard-of-care maintenance therapy plus tomivosertib in the treatment group versus standard-of-care maintenance plus placebo in the control group. Standard-of-care maintenance therapy is defined as pembrolizumab plus pemetrexed in non-squamous NSCLC and pembrolizumab in squamous NSCLC. Progression free survival are primary endpoints in each cohort separately; key secondary endpoints include safety, objective response rate and overall survival.