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
Tomivosertib With Anti-PD-(L)1 in Subjects With Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Effector Therapeutics
Enrolling: Male and Female Patients
IRB Number: AAAT5277
U.S. Govt. ID: NCT04622007
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of the study is to see whether tomivosertib in combination with pembrolizumab treatment slows down the growth of cancers. The study drug, tomivosertib, works by inhibiting the activity of proteins in a pathway that allows tumor cells to grow and go unnoticed by your immune system. This study will evaluate the safety and antitumor activity of tomivosertib versus placebo in subjects with Non-Small Cell Lung Cancer. There are two study arms for this study. Treatment arm A, in addition to taking study drug you will continue to receive pembrolizumab as either 200 mg by infusion at every 3 weeks or 400 mg by infusion every 6 weeks, and treatment arm B, in addition to taking study drug you will begin pembrolizumab as either 200 mg by infusion every 3 weeks or 400 mg by infusion every 6 weeks. This is a double-blind study, which means neither you nor the study doctor will know if you are receiving tomivosertib or placebo.
Investigator
Brian Henick, MD
Do You Qualify?
Are you age 18 or older? Yes No
Have you been diagnosed with non-small cell lung cancer? Yes No
Do you have a life expectancy of at least 3 months? Yes No
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For more information, please contact:
Research Nurse Navigator
cancerclinicaltrials@cumc.columbia.edu
212-342-5162