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ACTIVE NOT RECRUITING

NCT04622007

PHASE2

Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART)

Sponsor: Effector Therapeutics

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-06-02

Completion Date

2024-12-09

Last Updated

2024-04-30

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer

Interventions

DRUG

Tomivosertib

Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals

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.

DRUG

Pemetrexed

Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks.

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

Locations (144)

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

Clinical Research Directory

Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (144)