Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART)
NCT ID: NCT04622007
Last Updated: 2024-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
68 participants
INTERVENTIONAL
2021-06-02
2024-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Tomivosertib
Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals
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.
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.
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.
B1 Tomi + Pembro
Subjects will initiate pembrolizumab as first-line therapy and receive tomivosertib.
Tomivosertib
Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals
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.
Pbo + Pembro
Subjects will initiate pembrolizumab as first-line therapy and receive matching placebo.
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.
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.
Tomivosertib
Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals
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.
Pemetrexed
Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks.
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.
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.
Pemetrexed
Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks.
Interventions
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Tomivosertib
Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals
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.
Pemetrexed
Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
ALL
No
Sponsors
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Medpace, Inc.
INDUSTRY
ICON plc
INDUSTRY
Effector Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Douglas Warner, MD
Role: STUDY_DIRECTOR
EFFECTOR Therapeutics, Inc.
Locations
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Southern Cancer Center
Daphne, Alabama, United States
Southern Cancer Center, PC (Mobile Infirmary Circle)
Mobile, Alabama, United States
Southern Cancer Center, PC (Airport Blvd)
Mobile, Alabama, United States
Southern Cancer Center, PC (Dauphin St)
Mobile, Alabama, United States
Arizona Oncology Associates, PC - HAL (W Bell Rd)
Glendale, Arizona, United States
Arizona Oncology Associates, PC - NAHOA (W. McDowell)
Goodyear, Arizona, United States
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States
Arizona Oncology Associates, PC-NAHOA (N. Windsong)
Prescott Valley, Arizona, United States
Arizona Oncology Associates (N. Pima Rd)
Scottsdale, Arizona, United States
Arizona Oncology Associates, PC - HAL
Scottsdale, Arizona, United States
Arizona Oncology Associates, PC - HAL
Tempe, Arizona, United States
Arizona Oncology Associates, PC - HOPE (W. Orange Grove)
Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPE (W. Rudasill Rd)
Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPE (West St.)
Tucson, Arizona, United States
University of California, Los Angeles (UCLA) - Alhambra
Alhambra, California, United States
Comprehensive Blood And Cancer Center
Bakersfield, California, United States
TOI Clincal Research
Cerritos, California, United States
California Cancer Associates for Research & Excellence (San Diego Pacific Oncology and Hematology Associates) - Encinitas
Encinitas, California, United States
City of Hope - Long Beach Elm
Long Beach, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Mercy Cancer Center
Merced, California, United States
Mercy UC Davis Center Center
Merced, California, United States
Keck Medicine of USC Norris Oncology/Hematology
Newport Beach, California, United States
University of California - Irvine Medical Center
Orange, California, United States
University of California, Los Angeles (UCLA) - Porter Ranch
Porter Ranch, California, United States
St. Mary's Medical Center - San Francisco
San Francisco, California, United States
Dignity Health- SLO Oncology and Hematology
San Luis Obispo, California, United States
University of California, Los Angeles (UCLA) - San Luis Obispo
San Luis Obispo, California, United States
California Cancer Associates for Research & Excellence (San Diego Pacific Oncology and Hematology Associates) - San Marcos Cancer Center
San Marcos, California, United States
Mission Hope Cancer Center
Santa Maria, California, United States
Dignity Health St. Joseph's Medical Center Stockton
Stockton, California, United States
Stockton Hematology Oncology Medical Group (Stockton)
Stockton, California, United States
Santa Clarita - UCLA
Valencia, California, United States
Ventura - UCLA
Ventura, California, United States
PIH Health Hospital - Whittier
Whittier, California, United States
Rocky Mountain Cancer Centers (South Potomac St)
Aurora, Colorado, United States
Rocky Mountain Cancer Centers (Arapahoe Ave)
Boulder, Colorado, United States
Rocky Mountain Cancer Centers (E Arapahoe Rd)
Centennial, Colorado, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers, Colorado Springs CO (Peregrine)
Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers (Williams St)
Denver, Colorado, United States
Rocky Mountain Cancer Centers (E. Hale Parkway)
Denver, Colorado, United States
Rocky Mountain Cancer Centers (West 2nd Place)
Lakewood, Colorado, United States
Rocky Mountain Cancer Centers (W Dry Creek Circle)
Littleton, Colorado, United States
Rocky Mountain Cancer Centers (Ridge Gate Parkway)
Lone Tree, Colorado, United States
Rocky Mountain Cancer Centers (E. Ken Pratt Blvd)
Longmont, Colorado, United States
Rocky Mountain Cancer Centers (Ridge Gate Parkway)
Pueblo, Colorado, United States
Rocky Mountain Cancer Centers (Huron St)
Thornton, Colorado, United States
ASCLEPES Research Centers
Brooksville, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
Cancer Care Centers of Brevard (Melbourne)
Melbourne, Florida, United States
University of Florida (UF) Health Cancer Center - Orlando Health
Orlando, Florida, United States
Cancer Care Centers of Brevard
Palm Bay, Florida, United States
Memorial Cancer Institute at Memorial West Hospital
Pembroke Pines, Florida, United States
Woodlands Medical Specialists, PA
Pensacola, Florida, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Baptist Health - Lexington
Lexington, Kentucky, United States
Baptist Health - Louisville
Louisville, Kentucky, United States
Luminus Health Research Institute, Inc.
Annapolis, Maryland, United States
Maryland Oncology Hematology, P.A. (Rockledge Dr)
Bethesda, Maryland, United States
Maryland Oncology Hematology, P.A. (Matapeake Business Dr)
Brandywine, Maryland, United States
Maryland Oncology Hematology, P.A. (Woodyard Rd)
Clinton, Maryland, United States
Maryland Oncology Hematology, P.A
Columbia, Maryland, United States
Maryland Oncology Hematology, P.A. (Thomas Johnson Dr)
Frederick, Maryland, United States
Maryland Oncology Hematology, P.A. (Good Luck Rd)
Lanham, Maryland, United States
Maryland Oncology Hematology, P.A. (Medical Center Drive)
Rockville, Maryland, United States
Maryland Oncology Hematology, P.A. (Healing Way)
Silver Spring, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Metro Minnesota CCOP
Saint Louis Park, Minnesota, United States
Mercy Cancer Center
Joplin, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
St. Vincent Frontier Cancer Center
Billings, Montana, United States
Broome Oncology
Binghamton, New York, United States
Broome Oncology, LLC (Harrison St)
Johnson City, New York, United States
Columbia University Medical Center
New York, New York, United States
Columbia University
New York, New York, United States
Messino Cancer Center
Asheville, North Carolina, United States
Mercy Hematology and Oncology Associates
Canton, Ohio, United States
Gabrail Cancer Center
Canton, Ohio, United States
VA Medical Center- Dayton
Dayton, Ohio, United States
Tri-County Hematology & Oncology Associates
Dover, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Tri-County Hematology & Oncology Associates - Massillon
Massillon, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Willamette Valley Cancer Institute and Research Ctr
Eugene, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Prisma Health Cancer Institute
Greenville, South Carolina, United States
Prairie Lakes Cancer Center
Watertown, South Dakota, United States
Texas Oncology - West Texas (Antilley Rd)
Abilene, Texas, United States
Texas Oncology-Austin Midtown (W. 38th St)
Austin, Texas, United States
Texas Oncology-Austin Central (Balcones Dr.)
Austin, Texas, United States
Texas Oncology - South Austin
Austin, Texas, United States
Texas Oncology Gulf Coast - Beaumont (College St)
Beaumont, Texas, United States
Texas Oncology Gulf Coast - Beaumont Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology - Bedford
Bedford, Texas, United States
Texas Oncology-Carrollton (N Josey Lane)
Carlton, Texas, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
Texas Oncology - Denton
Denton, Texas, United States
Texas Oncology - West Texas (Grandview Ave)
El Paso, Texas, United States
Texas Oncology - West Texas
El Paso, Texas, United States
Texas Oncology - West Texas (Gateway Blvd E)
El Paso, Texas, United States
Texas Oncology - West Texas (Joe Battle Dr)
El Paso, Texas, United States
Texas Oncology - Flower Mound - Carrollton
Flower Mound, Texas, United States
Texas Oncology - Fort Worth Cancer Center
Fort Worth, Texas, United States
Texas Oncology-Grapevine
Grapevine, Texas, United States
Valley Cancer Associates
Harlingen, Texas, United States
Texas Oncology - Memorial City
Houston, Texas, United States
Oncology Consultants
Houston, Texas, United States
Texas Oncology Gulf Coast (Willowbrook)
Houston, Texas, United States
Texas Oncology - Longview Cancer Center
Longview, Texas, United States
Texas Oncology - West Texas (Odessa)
Odessa, Texas, United States
Texas Oncology - Palestine
Palestine, Texas, United States
Texas Oncology - Paris
Paris, Texas, United States
Texas Oncology - Plano East
Plano, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Texas Oncology - Waco
Waco, Texas, United States
Texas Oncology Golf Coast - Deke Slayton Cancer Center
Webster, Texas, United States
Virginia Cancer Specialists, PC (Kenmore Ave)
Alexandria, Virginia, United States
Virginia Cancer Specialists, PC (N George Mason Dr)
Arlington, Virginia, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Virginia Cancer Specialists, PC (Lake Manassas Dr)
Gainesville, Virginia, United States
Virginia Cancer Specialists, PC (Riverside Pkwy)
Leesburg, Virginia, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
MultiCare Regional Cancer Center
Spokane, Washington, United States
West Virginia University Cancer Institute
Morgantown, West Virginia, United States
Gold Coast Cancer Care - Pindara
Benowa, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Ballarat Regional Integrated Cancer Center
Ballarat, Victoria, Australia
High Technology Hospital MedCenter Ltd
Batumi, Adjara, Georgia
TIM - Tbilisi Institute of Medicine LLC
Tbilisi, Tbilisa, Georgia
JSC Vian - Kutaisi Referral Hospital
Kutaisi, , Georgia
Israel-Georgia Medical Research Clinic Healthycore LLC
Tbilisi, , Georgia
Todua Clinic LLC
Tbilisi, , Georgia
Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
Tbilisi, , Georgia
Oncology Scientific Research Center LLC
Tbilisi, , Georgia
Multiprofile Clinic Consilium Medulla LLC
Tbilisi, , Georgia
JSC Viani
Tbilisi, , Georgia
Caucasus Medical Centre LLC
Tbilisi, , Georgia
Countries
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References
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Luo H, Huang S. Inhibition of MNK pathway sensitizes nasopharyngeal carcinoma to radiotherapy. Anticancer Drugs. 2024 Feb 1;35(2):155-162. doi: 10.1097/CAD.0000000000001542. Epub 2023 Sep 11.
Other Identifiers
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eFT508-0011
Identifier Type: -
Identifier Source: org_study_id
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