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 NSCLC as First Line Therapy or When Progressing on Single-Agent First-Line Anti PD (L)1 Therapy

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

Study Overview

• Status: Active, not recruiting
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Tomivosertib; Biological: Pembrolizumab; Drug: Pemetrexed

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

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Mark Densel; Phone Number: 858-925-8215; Email: clinicaltrials@effector.com

Study Locations

• Australia
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Gold Coast Cancer Care - Pindara
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Victoria
    • Ballarat, Victoria, Australia, 3350
      • Ballarat Regional Integrated Cancer Center
• Georgia
  • Kutaisi, Georgia, 4600
    • JSC Vian - Kutaisi Referral Hospital
  • Tbilisi, Georgia, 0112
    • Israel-Georgia Medical Research Clinic Healthycore LLC
  • Tbilisi, Georgia, 0112
    • Todua Clinic LLC
  • Tbilisi, Georgia, 0144
    • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
  • Tbilisi, Georgia, 0177
    • Oncology Scientific Research Center LLC
  • Tbilisi, Georgia, 0186
    • Multiprofile Clinic Consilium Medulla Llc
  • Tbilisi, Georgia, 159
    • JSC Viani
  • Tbilisi, Georgia, 186
    • Caucasus Medical Centre Llc
  • Adjara
    • Batumi, Adjara, Georgia, 6000
      • High Technology Hospital MedCenter Ltd
  • Tbilisa
    • Tbilisi, Tbilisa, Georgia, 0160
      • TIM - Tbilisi Institute of Medicine LLC
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • Southern Cancer Center
    • Mobile, Alabama, United States, 36607
      • Southern Cancer Center, PC (Mobile Infirmary Circle)
    • Mobile, Alabama, United States, 36608
      • Southern Cancer Center, PC (Airport Blvd)
    • Mobile, Alabama, United States, 36608
      • Southern Cancer Center, PC (Dauphin St)
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Arizona Oncology Associates, PC - HAL (W Bell Rd)
    • Goodyear, Arizona, United States, 85395
      • Arizona Oncology Associates, PC - NAHOA (W. McDowell)
    • Phoenix, Arizona, United States, 85016
      • Arizona Oncology Associates, PC - HAL
    • Prescott Valley, Arizona, United States, 86314
      • Arizona Oncology Associates, PC-NAHOA (N. Windsong)
    • Scottsdale, Arizona, United States, 85258
      • Arizona Oncology Associates, PC - HAL
    • Scottsdale, Arizona, United States, 85258
      • Arizona Oncology Associates (N. Pima Rd)
    • Tempe, Arizona, United States, 85284
      • Arizona Oncology Associates, PC - HAL
    • Tucson, Arizona, United States, 85711
      • Arizona Oncology Associates, PC - HOPE
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates, PC - HOPE (W. Orange Grove)
    • Tucson, Arizona, United States, 85704
      • Arizona Oncology Associates, PC - HOPE (W. Rudasill Rd)
    • Tucson, Arizona, United States, 85745
      • Arizona Oncology Associates, PC - HOPE (West St.)
  • California
    • Alhambra, California, United States, 91801
      • University of California, Los Angeles (UCLA) - Alhambra
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood And Cancer Center
    • Cerritos, California, United States, 90703
      • TOI Clincal Research
    • Encinitas, California, United States, 92024
      • California Cancer Associates for Research & Excellence (San Diego Pacific Oncology and Hematology Associates) - Encinitas
    • Long Beach, California, United States, 90813
      • City of Hope - Long Beach Elm
    • Los Alamitos, California, United States, 90720
      • Cancer and Blood Specialty Clinic
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center
    • Los Angeles, California, United States, 90025
      • University of California, Los Angeles (UCLA)
    • Merced, California, United States, 95340
      • Mercy Cancer Center
    • Merced, California, United States, 95340
      • Mercy UC Davis Center Center
    • Newport Beach, California, United States, 92663
      • Keck Medicine of USC Norris Oncology/Hematology
    • Orange, California, United States, 92868
      • University of California - Irvine Medical Center
    • Porter Ranch, California, United States, 91326
      • University of California, Los Angeles (UCLA) - Porter Ranch
    • San Francisco, California, United States, 94117
      • St. Mary's Medical Center - San Francisco
    • San Luis Obispo, California, United States, 93401
      • Dignity Health- SLO Oncology and Hematology
    • San Luis Obispo, California, United States, 93401
      • University of California, Los Angeles (UCLA) - San Luis Obispo
    • San Marcos, California, United States, 92069
      • California Cancer Associates for Research & Excellence (San Diego Pacific Oncology and Hematology Associates) - San Marcos Cancer Center
    • Santa Maria, California, United States, 93454
      • Mission Hope Cancer Center
    • Stockton, California, United States, 95204
      • Dignity Health St. Joseph's Medical Center Stockton
    • Stockton, California, United States, 95204
      • Stockton Hematology Oncology Medical Group (Stockton)
    • Valencia, California, United States, 91355
      • Santa Clarita - UCLA
    • Ventura, California, United States, 93003
      • Ventura - UCLA
    • Whittier, California, United States, 90602
      • PIH Health Hospital - Whittier
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers (South Potomac St)
    • Boulder, Colorado, United States, 80303
      • Rocky Mountain Cancer Centers (Arapahoe Ave)
    • Centennial, Colorado, United States, 80112
      • Rocky Mountain Cancer Centers (E Arapahoe Rd)
    • Colorado Springs, Colorado, United States, 80907
      • Rocky Mountain Cancer Centers
    • Colorado Springs, Colorado, United States, 80923
      • Rocky Mountain Cancer Centers, Colorado Springs CO (Peregrine)
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers (Williams St)
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Centers (E. Hale Parkway)
    • Lakewood, Colorado, United States, 80228
      • Rocky Mountain Cancer Centers (West 2nd Place)
    • Littleton, Colorado, United States, 80120-4413
      • Rocky Mountain Cancer Centers (W Dry Creek Circle)
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Centers (Ridge Gate Parkway)
    • Longmont, Colorado, United States, 80504
      • Rocky Mountain Cancer Centers (E. Ken Pratt Blvd)
    • Pueblo, Colorado, United States, 81008
      • Rocky Mountain Cancer Centers (Ridge Gate Parkway)
    • Thornton, Colorado, United States, 80260
      • Rocky Mountain Cancer Centers (Huron St)
  • Florida
    • Brooksville, Florida, United States, 34613
      • ASCLEPES Research Centers
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
    • Melbourne, Florida, United States, 32935
      • Cancer Care Centers of Brevard (Melbourne)
    • Orlando, Florida, United States, 32806
      • University of Florida (UF) Health Cancer Center - Orlando Health
    • Palm Bay, Florida, United States, 32901
      • Cancer Care Centers of Brevard
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Cancer Institute at Memorial West Hospital
    • Pensacola, Florida, United States, 32503
      • Woodlands Medical Specialists, PA
  • Georgia
    • Columbus, Georgia, United States, 31904
      • John B. Amos Cancer Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology and Hematology
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health - Lexington
    • Louisville, Kentucky, United States, 40207
      • Baptist Health - Louisville
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Luminus Health Research Institute, Inc.
    • Bethesda, Maryland, United States, 20817
      • Maryland Oncology Hematology, P.A. (Rockledge Dr)
    • Brandywine, Maryland, United States, 20613
      • Maryland Oncology Hematology, P.A. (Matapeake Business Dr)
    • Clinton, Maryland, United States, 20735
      • Maryland Oncology Hematology, P.A. (Woodyard Rd)
    • Columbia, Maryland, United States, 21044
      • Maryland Oncology Hematology, P.A
    • Frederick, Maryland, United States, 21702
      • Maryland Oncology Hematology, P.A. (Thomas Johnson Dr)
    • Lanham, Maryland, United States, 20706
      • Maryland Oncology Hematology, P.A. (Good Luck Rd)
    • Rockville, Maryland, United States, 20850
      • Maryland Oncology Hematology, P.A. (Medical Center Drive)
    • Silver Spring, Maryland, United States, 20904
      • Maryland Oncology Hematology, P.A. (Healing Way)
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro Minnesota CCOP
  • Missouri
    • Joplin, Missouri, United States, 64804
      • Mercy Cancer Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Montana
    • Billings, Montana, United States, 59102
      • St. Vincent Frontier Cancer Center
  • New York
    • Binghamton, New York, United States, 13905
      • Broome Oncology
    • Johnson City, New York, United States, 13790
      • Broome Oncology, LLC (Harrison St)
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10032
      • Columbia University
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Messino Cancer Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
    • Canton, Ohio, United States, 44708
      • Mercy Hematology and Oncology Associates
    • Dayton, Ohio, United States, 45428
      • VA Medical Center- Dayton
    • Dover, Ohio, United States, 44622
      • Tri-County Hematology & Oncology Associates
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
    • Massillon, Ohio, United States, 44646
      • Tri-County Hematology & Oncology Associates - Massillon
    • Toledo, Ohio, United States, 43614
      • University of Toledo
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Willamette Valley Cancer Institute and Research Ctr
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Cancer Institute
  • South Dakota
    • Watertown, South Dakota, United States, 57201
      • Prairie Lakes Cancer Center
  • Texas
    • Abilene, Texas, United States, 79606-5208
      • Texas Oncology - West Texas (Antilley Rd)
    • Austin, Texas, United States, 78745
      • Texas Oncology - South Austin
    • Austin, Texas, United States, 78705
      • Texas Oncology-Austin Midtown (W. 38th St)
    • Austin, Texas, United States, 78731
      • Texas Oncology-Austin Central (Balcones Dr.)
    • Beaumont, Texas, United States, 77701
      • Texas Oncology Gulf Coast - Beaumont (College St)
    • Beaumont, Texas, United States, 77702
      • Texas Oncology Gulf Coast - Beaumont Mamie McFaddin Ward Cancer Center
    • Bedford, Texas, United States, 76022
      • Texas Oncology - Bedford
    • Carlton, Texas, United States, 75010
      • Texas Oncology-Carrollton (N Josey Lane)
    • Dallas, Texas, United States, 75231
      • Texas Oncology - Dallas Presbyterian Hospital
    • Dallas, Texas, United States, 75246
      • Texas Oncology-Baylor Charles A. Sammons Cancer Center
    • Denton, Texas, United States, 76201
      • Texas Oncology - Denton
    • El Paso, Texas, United States, 79902
      • Texas Oncology - West Texas (Grandview Ave)
    • El Paso, Texas, United States, 79902
      • Texas Oncology - West Texas
    • El Paso, Texas, United States, 79915
      • Texas Oncology - West Texas (Gateway Blvd E)
    • El Paso, Texas, United States, 79938
      • Texas Oncology - West Texas (Joe Battle Dr)
    • Flower Mound, Texas, United States, 75028
      • Texas Oncology - Flower Mound - Carrollton
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - Fort Worth Cancer Center
    • Grapevine, Texas, United States, 76051
      • Texas Oncology-Grapevine
    • Harlingen, Texas, United States, 78550
      • Valley Cancer Associates
    • Houston, Texas, United States, 77030
      • Oncology Consultants
    • Houston, Texas, United States, 77024
      • Texas Oncology - Memorial City
    • Houston, Texas, United States, 77070
      • Texas Oncology Gulf Coast (Willowbrook)
    • Longview, Texas, United States, 75601
      • Texas Oncology - Longview Cancer Center
    • Odessa, Texas, United States, 79761
      • Texas Oncology - West Texas (Odessa)
    • Palestine, Texas, United States, 75801
      • Texas Oncology - Palestine
    • Paris, Texas, United States, 75460
      • Texas Oncology - Paris
    • Plano, Texas, United States, 75075
      • Texas Oncology - Plano East
    • Tyler, Texas, United States, 75702
      • Texas Oncology - Tyler
    • Waco, Texas, United States, 76712
      • Texas Oncology - Waco
    • Webster, Texas, United States, 77598
      • Texas Oncology Golf Coast - Deke Slayton Cancer Center
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Virginia Cancer Specialists, PC (Kenmore Ave)
    • Arlington, Virginia, United States, 22205
      • Virginia Cancer Specialists, PC (N George Mason Dr)
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
    • Gainesville, Virginia, United States, 20155
      • Virginia Cancer Specialists, PC (Lake Manassas Dr)
    • Leesburg, Virginia, United States, 20176
      • Virginia Cancer Specialists, PC (Riverside Pkwy)
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Regional Cancer Partnership
    • Spokane, Washington, United States, 99204
      • MultiCare Regional Cancer Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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.

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:

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:

  1. Have histologically confirmed NSCLC that is inoperable, locally advanced or metastatic (Stage IIIb/IV)
  2. 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
  3. Have provided written informed consent and any authorizations required by local law
  4. Are ≥18 years of age
  5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

1. Have NSCLC with epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations
2. Have gastrointestinal (GI) disease (eg, gastric or intestinal bypass surgery, pancreatic enzyme insufficiency, malabsorption syndrome, symptomatic inflammatory bowel disease, chronic diarrheal illness, and/or bowel obstruction) that may interfere with drug absorption or with interpretation of GI AEs
3. Have known symptomatic brain metastases requiring >10 mg/day of prednisone (or its equivalent). Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to randomization, fulfill the steroid requirement for these metastases, the 2 most recent serial magnetic resonance imaging (MRI) scans conducted >28 days apart show no central nervous system progression, and are neurologically stable and asymptomatic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1 Tomi + Current Pembro; Subjects who have initiated pembrolizumab as a single agent and in accordance with the package insert will receive tomivosertib in addition to pembrolizumab.	Drug: Tomivosertib; Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals; Other Names: eFT508; 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.; Other Names: Keytruda®
Placebo Comparator: Pbo + Current Pembro; Subjects who have initiated pembrolizumab as a single agent and in accordance with the package insert, will receive matching placebo in addition to pembrolizumab.	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.; Other Names: Keytruda®
Experimental: B1 Tomi + Pembro; Subjects will initiate pembrolizumab as first-line therapy and receive tomivosertib.	Drug: Tomivosertib; Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals; Other Names: eFT508; 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.; Other Names: Keytruda®
Placebo Comparator: Pbo + Pembro; Subjects will initiate pembrolizumab as first-line therapy and receive matching placebo.	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.; Other Names: Keytruda®
Experimental: C1 Tomi + Pembro + Pemetrexed (Non-sqamous) or Tomi + Pembro (Squamous); 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.	Drug: Tomivosertib; Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals; Other Names: eFT508; 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.; Other Names: Keytruda®; Drug: Pemetrexed; Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks.; Other Names: Alimta®
Placebo Comparator: Pbo + Pembro + Pemetrexed (Non-sqamous) or Pbo + Pembro (Squamous); 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.	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.; Other Names: Keytruda®; Drug: Pemetrexed; Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks.; Other Names: Alimta®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize the progression-free survival (PFS) of tomivosertib when added to pembrolizumab as a first-line treatment; and	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.	2 years
To characterize the PFS of tomivosertib when added to pembrolizumab as first line therapy.	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.	2 years
To characterize the PFS of tomivosertib when added to pembrolizumab and pemetrexed in non-squamous NSCLC, and pembrolizumab in squamous NSCLC as first line maintenance therapy.	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To characterize the PFS of tomivosertib when added to pembrolizumab in Cohorts A, B, and B C individually and combined	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.	2 years
To characterize the PFS of tomivosertib when added to pembrolizumab as a first-line treatment in subjects with NSCLC	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. Objective response per RECIST 1.1, as assessed by the BIRC.	2 years
To characterize the PFS of tomivosertib when added to pembrolizumab and pemetrexed in non-squamous NSCLC, and pembrolizumab in squamous NSCLC as a first-line maintenance treatment in subjects with NSCLC.	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. Objective response per RECIST 1.1, as assessed by the BIRC.	2 years
To characterize the PFS of tomivosertib when added to pembrolizumab after first radiographic progression on pembrolizumab monotherapy	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. Objective response per RECIST 1.1, as assessed by the BIRC	2 years

Collaborators and Investigators

• Sponsor: Effector Therapeutics
• Collaborators: Medpace, Inc.; ICON plc
• Investigators: Study Director: Douglas Warner, MD, EFFECTOR Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Estimated): March 15, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 9, 2020

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Folic Acid Antagonists; Pembrolizumab; Pemetrexed
• Other Study ID Numbers: eFT508-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No