Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04622007 | Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART) | PHASE2 | ACTIVE NOT_RECRUITING | 68 | — | — | Jun 2, 2021 | Dec 9, 2024 | Apr 30, 2024 | 144 | United States, Australia +1 |
Defined as the time from randomization to the first occurrence of disease progression as assessed by the Investigator using RECIST 1.1 or death from any cause, whichever occurs earlier.
Defined as the time from randomization to the first occurrence of disease progression as assessed by the Investigator using RECIST 1.1 or death from any cause, whichever occurs earlier.
Defined as the time from randomization to the first occurrence of disease progression as assessed by the Investigator using RECIST 1.1 or death from any cause, whichever occurs earlier.
| Arm | Type | Description |
|---|---|---|
| A1 Tomi + Current Pembro | EXPERIMENTAL | Subjects who have initiated pembrolizumab as a single agent and in accordance with the package insert will receive tomivosertib in addition to pembrolizumab. |
| Pbo + Current Pembro | PLACEBO_COMPARATOR | Subjects who have initiated pembrolizumab as a single agent and in accordance with the package insert, will receive matching placebo in addition to pembrolizumab. |
| B1 Tomi + Pembro | EXPERIMENTAL | Subjects will initiate pembrolizumab as first-line therapy and receive tomivosertib. |
| Pbo + Pembro | PLACEBO_COMPARATOR | Subjects will initiate pembrolizumab as first-line therapy and receive matching placebo. |
| C1 Tomi + Pembro + Pemetrexed (Non-sqamous) or Tomi + Pembro (Squamous) | EXPERIMENTAL | Subjects who have completed 4 to 6 cycles of platinum-based chemotherapy doublet will receive tomi plus pembrolizumab and pemetrexed (non-squamous NSCLC) or tomi plus pembro as a single agent (squamous) in accordance with the package insert. |
| Pbo + Pembro + Pemetrexed (Non-sqamous) or Pbo + Pembro (Squamous) | PLACEBO_COMPARATOR | Subjects who have completed 4 to 6 cycles of platinum-based chemotherapy doublet will receive placebo plus pembrolizumab and pemetrexed (non-squamous NSCLC) or placebo plus pembro as a single agent (squamous) in accordance with the package insert. |
| Name | Type | Description |
|---|---|---|
| Tomivosertib | DRUG | Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals |
| Pembrolizumab | BIOLOGICAL | Subjects will initiate or continue to receive pembrolizumab at either 200 mg intravenously (IV) at a frequency of every 3 weeks or 400 mg IV at a frequency of every 6 weeks. |
| Pemetrexed | DRUG | Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks. |
Inclusion Criteria: Inclusion Criteria for Cohort A: Subjects who meet all of the following criteria will be eligible to participate in Cohort A of the study: 1\. Have initiated first-line therapy for NSCLC with pembrolizumab and satisfy the following: * Have tumor PD-L1 ≥1% by 22C3 IHC; * Are ju...