Tomivosertib With Pembrolizumab In Subjects with NSCLC, 1st Line Therapy or Progressing On 1st Line Pembrolizumab Therapy (Kickstart)

Trial Status:
Actively recruiting

Program (Target):
eFT508/tomivosertib (MNK)

Disease Indication:

1L metastatic NSCLC and 1L extension NSCLC with PD-L1 ≧ 50%

Disease Information:
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 and 1L extension metastatic NSCLC patients with PD-L1 ≧ 50%.  All eligible patients must not have received chemotherapy for metastatic NSCLC.

Clinical Trial Description:
This clinical trial is a randomized, placebo-controlled, multi-center Phase 2b enrolling approximately 120 patients.  Approximately 60 patients will be enrolled in the 1L metastatic NSCLC setting with PD-L1 ≧ 50% and randomized 1:1 to receive either tomivosertib plus pembrolizumab or placebo plus pembrolizumab.  An additional approximately 60 patients will be enrolled in 1L extension metastatic NSCLC (with PD-L1 ≧ 50%) setting, upon initial RECIST PD on pembrolizumab.  Patients will be randomized 1:1 to receive either tomivosertib plus pembrolizumab or placebo plus pembrolizumab.  Progression free survival in the 1L NSCLC and 1L extension NSCLC cohorts are co-primary endpoints; key secondary endpoints include objective response rate and overall survival.