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Non-small Cell Lung CancerPhase 2KICKSTARTNCT04622007

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

A Phase 2 study testing Tomivosertib, Pembrolizumab and Pemetrexed in people with Non-small Cell Lung Cancer, run by Effector Therapeutics at 144 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Tomivosertib combined with pembrolizumab in Subjects with PD-L1 positive NSCLC Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Tomivosertib, Pembrolizumab and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
144 sitesin 3 countries
Study dates
2 Jun 2021to 9 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 22Show fewer
  • The 2 most recent scans (including 1 demonstrating Progressive Disease) are available to be reviewed
  • 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
  • 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

Who cannot join

  • Have NSCLC with epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations
  • 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
  • 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

Trial locations and contacts

144 sites in 3 countries.

144 sites in 3 countries

United States131 sites

  • Texas Oncology - West Texas (Antilley Rd)

    Abilene, Texas, 79606-5208

  • Virginia Cancer Specialists, PC (Kenmore Ave)

    Alexandria, Virginia, 22304

  • University of California, Los Angeles (UCLA) - Alhambra

    Alhambra, California, 91801

  • Luminus Health Research Institute, Inc.

    Annapolis, Maryland, 21401

  • Virginia Cancer Specialists, PC (N George Mason Dr)

    Arlington, Virginia, 22205

  • Messino Cancer Center

    Asheville, North Carolina, 28806

  • Rocky Mountain Cancer Centers (South Potomac St)

    Aurora, Colorado, 80012

  • Texas Oncology-Austin Midtown (W. 38th St)

    Austin, Texas, 78705

  • Texas Oncology-Austin Central (Balcones Dr.)

    Austin, Texas, 78731

  • Texas Oncology - South Austin

    Austin, Texas, 78745

  • Comprehensive Blood And Cancer Center

    Bakersfield, California, 93309

  • Texas Oncology Gulf Coast - Beaumont (College St)

    Beaumont, Texas, 77701

  • Texas Oncology Gulf Coast - Beaumont Mamie McFaddin Ward Cancer Center

    Beaumont, Texas, 77702

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • Maryland Oncology Hematology, P.A. (Rockledge Dr)

    Bethesda, Maryland, 20817

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Broome Oncology

    Binghamton, New York, 13905

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Rocky Mountain Cancer Centers (Arapahoe Ave)

    Boulder, Colorado, 80303

  • Maryland Oncology Hematology, P.A. (Matapeake Business Dr)

    Brandywine, Maryland, 20613

  • ASCLEPES Research Centers

    Brooksville, Florida, 34613

  • Mercy Hematology and Oncology Associates

    Canton, Ohio, 44708

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Texas Oncology-Carrollton (N Josey Lane)

    Carlton, Texas, 75010

  • Rocky Mountain Cancer Centers (E Arapahoe Rd)

    Centennial, Colorado, 80112

  • TOI Clincal Research

    Cerritos, California, 90703

  • Maryland Oncology Hematology, P.A. (Woodyard Rd)

    Clinton, Maryland, 20735

  • Rocky Mountain Cancer Centers

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers, Colorado Springs CO (Peregrine)

    Colorado Springs, Colorado, 80923

  • Maryland Oncology Hematology, P.A

    Columbia, Maryland, 21044

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Southern Cancer Center

    Daphne, Alabama, 36526

  • VA Medical Center- Dayton

    Dayton, Ohio, 45428

  • Texas Oncology - Denton

    Denton, Texas, 76201

  • Rocky Mountain Cancer Centers (Williams St)

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers (E. Hale Parkway)

    Denver, Colorado, 80220

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Tri-County Hematology & Oncology Associates

    Dover, Ohio, 44622

  • Texas Oncology - West Texas (Grandview Ave)

    El Paso, Texas, 79902

  • Texas Oncology - West Texas

    El Paso, Texas, 79902

  • Texas Oncology - West Texas (Gateway Blvd E)

    El Paso, Texas, 79915

  • Texas Oncology - West Texas (Joe Battle Dr)

    El Paso, Texas, 79938

  • California Cancer Associates for Research & Excellence (San Diego Pacific Oncology and Hematology Associates) - Encinitas

    Encinitas, California, 92024

  • Willamette Valley Cancer Institute and Research Ctr

    Eugene, Oregon, 97401

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Texas Oncology - Flower Mound - Carrollton

    Flower Mound, Texas, 75028

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Maryland Oncology Hematology, P.A. (Thomas Johnson Dr)

    Frederick, Maryland, 21702

  • Virginia Cancer Specialists, PC (Lake Manassas Dr)

    Gainesville, Virginia, 20155

  • Arizona Oncology Associates, PC - HAL (W Bell Rd)

    Glendale, Arizona, 85308

  • Arizona Oncology Associates, PC - NAHOA (W. McDowell)

    Goodyear, Arizona, 85395

  • Texas Oncology-Grapevine

    Grapevine, Texas, 76051

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29615

  • Valley Cancer Associates

    Harlingen, Texas, 78550

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

  • Oncology Consultants

    Houston, Texas, 77030

  • Texas Oncology Gulf Coast (Willowbrook)

    Houston, Texas, 77070

  • Broome Oncology, LLC (Harrison St)

    Johnson City, New York, 13790

  • Mercy Cancer Center

    Joplin, Missouri, 64804

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Rocky Mountain Cancer Centers (West 2nd Place)

    Lakewood, Colorado, 80228

  • Maryland Oncology Hematology, P.A. (Good Luck Rd)

    Lanham, Maryland, 20706

  • Virginia Cancer Specialists, PC (Riverside Pkwy)

    Leesburg, Virginia, 20176

  • Baptist Health - Lexington

    Lexington, Kentucky, 40503

  • Rocky Mountain Cancer Centers (W Dry Creek Circle)

    Littleton, Colorado, 80120-4413

  • Rocky Mountain Cancer Centers (Ridge Gate Parkway)

    Lone Tree, Colorado, 80124

  • City of Hope - Long Beach Elm

    Long Beach, California, 90813

  • Rocky Mountain Cancer Centers (E. Ken Pratt Blvd)

    Longmont, Colorado, 80504

  • Texas Oncology - Longview Cancer Center

    Longview, Texas, 75601

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • University of California, Los Angeles (UCLA)

    Los Angeles, California, 90025

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Baptist Health - Louisville

    Louisville, Kentucky, 40207

  • Tri-County Hematology & Oncology Associates - Massillon

    Massillon, Ohio, 44646

  • Cancer Care Centers of Brevard (Melbourne)

    Melbourne, Florida, 32935

  • Mercy Cancer Center

    Merced, California, 95340

  • Mercy UC Davis Center Center

    Merced, California, 95340

  • Southern Cancer Center, PC (Mobile Infirmary Circle)

    Mobile, Alabama, 36607

  • Southern Cancer Center, PC (Airport Blvd)

    Mobile, Alabama, 36608

  • Southern Cancer Center, PC (Dauphin St)

    Mobile, Alabama, 36608

  • West Virginia University Cancer Institute

    Morgantown, West Virginia, 26506

  • Columbia University Medical Center

    New York, New York, 10032

  • Columbia University

    New York, New York, 10032

  • Keck Medicine of USC Norris Oncology/Hematology

    Newport Beach, California, 92663

  • Texas Oncology - West Texas (Odessa)

    Odessa, Texas, 79761

  • University of California - Irvine Medical Center

    Orange, California, 92868

  • University of Florida (UF) Health Cancer Center - Orlando Health

    Orlando, Florida, 32806

  • Texas Oncology - Palestine

    Palestine, Texas, 75801

  • Cancer Care Centers of Brevard

    Palm Bay, Florida, 32901

  • Texas Oncology - Paris

    Paris, Texas, 75460

  • Memorial Cancer Institute at Memorial West Hospital

    Pembroke Pines, Florida, 33028

  • Woodlands Medical Specialists, PA

    Pensacola, Florida, 32503

  • Arizona Oncology Associates, PC - HAL

    Phoenix, Arizona, 85016

  • Texas Oncology - Plano East

    Plano, Texas, 75075

  • University of California, Los Angeles (UCLA) - Porter Ranch

    Porter Ranch, California, 91326

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Arizona Oncology Associates, PC-NAHOA (N. Windsong)

    Prescott Valley, Arizona, 86314

  • Rocky Mountain Cancer Centers (Ridge Gate Parkway)

    Pueblo, Colorado, 81008

  • Maryland Oncology Hematology, P.A. (Medical Center Drive)

    Rockville, Maryland, 20850

  • Metro Minnesota CCOP

    Saint Louis Park, Minnesota, 55416

  • St. Mary's Medical Center - San Francisco

    San Francisco, California, 94117

  • Dignity Health- SLO Oncology and Hematology

    San Luis Obispo, California, 93401

  • University of California, Los Angeles (UCLA) - San Luis Obispo

    San Luis Obispo, California, 93401

  • California Cancer Associates for Research & Excellence (San Diego Pacific Oncology and Hematology Associates) - San Marcos Cancer Center

    San Marcos, California, 92069

  • Mission Hope Cancer Center

    Santa Maria, California, 93454

  • Arizona Oncology Associates (N. Pima Rd)

    Scottsdale, Arizona, 85258

  • Arizona Oncology Associates, PC - HAL

    Scottsdale, Arizona, 85258

  • Maryland Oncology Hematology, P.A. (Healing Way)

    Silver Spring, Maryland, 20904

  • MultiCare Regional Cancer Center

    Spokane, Washington, 99204

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Dignity Health St. Joseph's Medical Center Stockton

    Stockton, California, 95204

  • Stockton Hematology Oncology Medical Group (Stockton)

    Stockton, California, 95204

  • Arizona Oncology Associates, PC - HAL

    Tempe, Arizona, 85284

  • Rocky Mountain Cancer Centers (Huron St)

    Thornton, Colorado, 80260

  • University of Toledo

    Toledo, Ohio, 43614

  • Arizona Oncology Associates, PC - HOPE (W. Orange Grove)

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, PC - HOPE (W. Rudasill Rd)

    Tucson, Arizona, 85704

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

  • Arizona Oncology Associates, PC - HOPE (West St.)

    Tucson, Arizona, 85745

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Santa Clarita - UCLA

    Valencia, California, 91355

  • Ventura - UCLA

    Ventura, California, 93003

  • Texas Oncology - Waco

    Waco, Texas, 76712

  • Prairie Lakes Cancer Center

    Watertown, South Dakota, 57201

  • Texas Oncology Golf Coast - Deke Slayton Cancer Center

    Webster, Texas, 77598

  • PIH Health Hospital - Whittier

    Whittier, California, 90602

Other trials in United States

Georgia10 sites

  • High Technology Hospital MedCenter Ltd

    Batumi, Adjara, 6000

  • JSC Vian - Kutaisi Referral Hospital

    Kutaisi, 4600

  • TIM - Tbilisi Institute of Medicine LLC

    Tbilisi, Tbilisa, 0160

  • Israel-Georgia Medical Research Clinic Healthycore LLC

    Tbilisi, 0112

  • Todua Clinic LLC

    Tbilisi, 0112

  • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC

    Tbilisi, 0144

  • Oncology Scientific Research Center LLC

    Tbilisi, 0177

  • Multiprofile Clinic Consilium Medulla LLC

    Tbilisi, 0186

  • JSC Viani

    Tbilisi, 159

  • Caucasus Medical Centre LLC

    Tbilisi, 186

Other trials in Georgia

Australia3 sites

  • Ballarat Regional Integrated Cancer Center

    Ballarat, Victoria, 3350

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Gold Coast Cancer Care - Pindara

    Benowa, Queensland, 4217

Other trials in Australia

About this study

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

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

Read the 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

Being tested
Tomivosertib, Pembrolizumab, Pemetrexed
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TomivosertibDrug

    Also called eFT508

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

  • PembrolizumabBiological

    Also called Keytruda®

    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.

  • PemetrexedDrug

    Also called Alimta®

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

Study groups in NCT04622007
Study groupRoleWhat they receive
A1 Tomi + Current PembroExperimentalSubjects who have initiated pembrolizumab as a single agent and in accordance with the package insert will receive tomivosertib in addition to pembrolizumab.
Receives: Drug: Tomivosertib; Biological: Pembrolizumab
Pbo + Current PembroPlacebo comparatorSubjects who have initiated pembrolizumab as a single agent and in accordance with the package insert, will receive matching placebo in addition to pembrolizumab.
Receives: Biological: Pembrolizumab
B1 Tomi + PembroExperimentalSubjects will initiate pembrolizumab as first-line therapy and receive tomivosertib.
Receives: Drug: Tomivosertib; Biological: Pembrolizumab
Pbo + PembroPlacebo comparatorSubjects will initiate pembrolizumab as first-line therapy and receive matching placebo.
Receives: Biological: Pembrolizumab
C1 Tomi + Pembro + Pemetrexed (Non-sqamous) or Tomi + Pembro (Squamous)ExperimentalSubjects 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.
Receives: Drug: Tomivosertib; Biological: Pembrolizumab; Drug: Pemetrexed
Pbo + Pembro + Pemetrexed (Non-sqamous) or Pbo + Pembro (Squamous)Placebo comparatorSubjects 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.
Receives: Biological: Pembrolizumab; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

Secondary outcomes (4)

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

  4. 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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start2 Jun 2021
  3. Primary completion14 Oct 2024 (estimated)
  4. Study completion9 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
In each Cohort approximately 60 eligible Subjects were targeted to be randomized to receive tomivosertib or matching placebo in combination with pembrolizumab (and pemetrexed, Cohort C). Cohorts A and C were closed to enrollment early due to recruitment challenges. In Cohort B, 54 subjects received blinded IP (tomivosertib or matching placebo) in combination with pembrolizumab as first line therapy.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04622007
Sponsor's protocol ID
eFT508-0011
Acronym
KICKSTART
Status last verified
Apr 2024
First submitted
3 Nov 2020
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37694854

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tomivosertib, Pembrolizumab and Pemetrexed in people with Non-small Cell Lung Cancer, run by Effector Therapeutics at 144 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Georgia, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To characterize the progression-free survival (PFS) of tomivosertib when added to pembrolizumab as a first-line treatment; and (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04622007, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.

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KICKSTART Clinical Trial NCT04622007 | AzTrials