NCT04622007

Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART)

A Randomized, Double-Blind, Placebo-Controlled Trial of Tomivosertib in Combination With Anti-PD-(L)1 Therapy in Subjects With NSCLC as First Line Therapy or When Progressing on Single-Agent First-Line Anti PD (L)1 Therapy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Effector Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tomivosertib combined with pembrolizumab in Subjects with PD-L1 positive NSCLC

Detailed description

A Randomized, Double-Blind, Placebo-Controlled Trial of Tomivosertib in Combination With Anti-PD-(L)1 Therapy in Subjects With Non-Small Cell Lung Cancer as First Line Therapy or When Progressing on Single-Agent First-Line Anti PD (L)1 Therapy

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tomivosertib	Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals
BIOLOGICAL	Pembrolizumab	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.
DRUG	Pemetrexed	Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks.

Timeline

• Start date: 2021-06-02
• Primary completion: 2024-10-14
• Completion: 2024-12-09
• First posted: 2020-11-09
• Last updated: 2024-04-30

Locations

144 sites across 3 countries: United States, Australia, Georgia

Regulatory

• FDA-regulated drug study