Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART) (KICKSTART)
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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Clinical Trial Information
Trial Contact: Casillas, Bridey L; Ribacchi, Stephanie; Durand, Jennifer
Trial Phone: 321.841.8284 ; 321-841-1077 ; 321.843.2026
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IRB No: 20202928
Protocol Abbrev: TRIO KICKSTART
Principal Investigator: Jennifer E. Tseng, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: eFT508-0011
Treatment: -Experimental: A1 Tomi + Current Pembro Placebo Comparator: Pbo + Current Pembro -Experimental: B1 Tomi + Pembro Placebo Comparator: Pbo + Pembro -Experimental: C1 Tomi + Pembro + Pemetrexed (Non-sqamous) or Tomi + Pembro (Squamous) Placebo Comparator: Pbo + Pembro + Pemetrexed (Non-sqamous) or Pbo + Pembro (Squamous)
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04622007
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Objective
Tomivosertib combined with pembrolizumab in Subjects with PD-L1 positive NSCLC.
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Key Eligibility
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 judged by the Principal Investigator as tolerating pembrolizumab monotherapy; and
Have been on pembrolizumab for at least 3 months (measured from actual first dose date to first dose date of the current study) and the most recent scans are the first scans to objectively demonstrate Progressive Disease per RECIST 1.1
The first scan conducted a minimum of 21 days after first dose of anti-PD-(L)1 therapy must have shown either SD, PR, or CR (ie, not Progressive Disease) per RECIST 1.1; and
The 2 most recent scans (including 1 demonstrating Progressive Disease) are available to be reviewed
Inclusion Criterion for Cohort B
Subjects who meet the following criterion will be eligible to participate in Cohort B of the study:
1. Are eligible for single-agent pembrolizumab for advanced/metastatic NSCLC in accordance with the package insert and have tumor PD-L1 ≥50% by 22C3 IHC
• 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.
Subjects who meet the following criterion will be eligible to participate in Cohort C of the study:
1. Have initiated IL therapy for NSCLC and completed all planned (eg, 4 to 6 cycles) platinum-based chemotherapy with at least 2 cycles in combination with pembrolizumab; must not have had progressive disease on tumor staging imaging scans following completion of all planned platinum chemotherapy
Are eligible for maintenance therapy with pembrolizumab ± pemetrexed in accordance with the package insert
Have tumor PD-L1 ≥1%
The last dose of platinum-based chemotherapy must be within 8 weeks of the first dose of the study drug in this study
Inclusion Criterion for All Cohorts
Subjects must also meet all of the following criteria to be eligible to participate in the study:
Have histologically confirmed NSCLC that is inoperable, locally advanced or metastatic (Stage IIIb/IV)
Have available at the site a representative formalin-fixed, paraffin-embedded tumor specimen that enabled diagnosis of NSCLC in a tissue block (preferred) or 10 unstained, serial slides, accompanied by an associated pathology report. Note: If the archival tissue is neither sufficient nor available, the subject may still be eligible, upon discussion with the Medical Monitor
Have provided written informed consent and any authorizations required by local law
Are ≥18 years of age
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
