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Tomivosertib combined with pembrolizumab in Subjects with PD-L1 positive NSCLC
Full 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
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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:
Inclusion Criterion for Cohort B
Subjects who meet the following criterion will be eligible to participate in Cohort B of the study:
• Must not have been treated previously with platinum-based chemotherapy in the advanced/metastatic setting. Note: Subjects may have received chemotherapy and/or anti PD (L)1 therapy in the neo/adjuvant setting, provided the last dose of therapy was >9 months prior to randomization.
All cohorts require PD-L1 testing (TPS as determined by an FDA-approved test: subjects in Cohort B must specifically have PD-L1 testing using the PD-L1 IHC 22C3 pharmDx test kit). Subjects in Cohort B for whom PD-L1 testing was not performed with the required IHC 22C3 pharmDx test kit may be randomized if all other study criteria have been met, pending retest with the required IHC 22C3 pharmDx test kit.
Subjects who meet the following criterion will be eligible to participate in Cohort C of the study:
Inclusion Criterion for All Cohorts
Subjects must also meet all of the following criteria to be eligible to participate in the study:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
68 participants in 6 patient groups, including a placebo group
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Central trial contact
Mark Densel
Data sourced from clinicaltrials.gov
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