Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04622007
Registration number
NCT04622007
Ethics application status
Date submitted
3/11/2020
Date registered
9/11/2020
Date last updated
30/04/2024
Titles & IDs
Public title
Tomivosertib Combined With Pembrolizumab in Subjects With PD-L1 Positive NSCLC (KICKSTART)
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
eFT508-0011
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
KICKSTART
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lung - Non small cell
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Tomivosertib
Other interventions - Pembrolizumab
Treatment: Drugs - Pemetrexed
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.
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.
Experimental: B1 Tomi + Pembro - Subjects will initiate pembrolizumab as first-line therapy and receive tomivosertib.
Placebo Comparator: Pbo + Pembro - Subjects will initiate pembrolizumab as first-line therapy and receive matching placebo.
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.
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.
Treatment: Drugs: Tomivosertib
Tomivosertib (eFT508) will be taken at 100 mg twice daily (bid) with meals
Other interventions: 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.
Treatment: Drugs: Pemetrexed
Subjects will initiate pemetrexed at 500 mg/m2 intravenously (IV) at a frequency of every 3 weeks.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
To characterize the progression-free survival (PFS) of tomivosertib when added to pembrolizumab as a first-line treatment; and
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
2 years
Query!
Primary outcome [2]
0
0
To characterize the PFS of tomivosertib when added to pembrolizumab as first line therapy.
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
2 years
Query!
Primary outcome [3]
0
0
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.
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
2 years
Query!
Secondary outcome [1]
0
0
To characterize the PFS of tomivosertib when added to pembrolizumab in Cohorts A, B, and B C individually and combined
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
2 years
Query!
Secondary outcome [2]
0
0
To characterize the PFS of tomivosertib when added to pembrolizumab as a first-line treatment in subjects with NSCLC
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
2 years
Query!
Secondary outcome [3]
0
0
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.
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
2 years
Query!
Secondary outcome [4]
0
0
To characterize the PFS of tomivosertib when added to pembrolizumab after first radiographic progression on pembrolizumab monotherapy
Query!
Assessment method [4]
0
0
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
Query!
Timepoint [4]
0
0
2 years
Query!
Eligibility
Key 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/06/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
9/12/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
68
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Gold Coast Cancer Care - Pindara - Benowa
Query!
Recruitment hospital [2]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [3]
0
0
Ballarat Regional Integrated Cancer Center - Ballarat
Query!
Recruitment postcode(s) [1]
0
0
4217 - Benowa
Query!
Recruitment postcode(s) [2]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [3]
0
0
3350 - Ballarat
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Indiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Kentucky
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Montana
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oregon
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
South Carolina
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
South Dakota
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Texas
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Virginia
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Washington
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
West Virginia
Query!
Country [25]
0
0
Georgia
Query!
State/province [25]
0
0
Adjara
Query!
Country [26]
0
0
Georgia
Query!
State/province [26]
0
0
Tbilisa
Query!
Country [27]
0
0
Georgia
Query!
State/province [27]
0
0
Kutaisi
Query!
Country [28]
0
0
Georgia
Query!
State/province [28]
0
0
Tbilisi
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Effector Therapeutics
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Medpace, Inc.
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Other collaborator category [2]
0
0
Commercial sector/Industry
Query!
Name [2]
0
0
ICON plc
Query!
Address [2]
0
0
Query!
Country [2]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Tomivosertib combined with pembrolizumab in Subjects with PD-L1 positive NSCLC
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04622007
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Douglas Warner, MD
Query!
Address
0
0
EFFECTOR Therapeutics, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04622007
Download to PDF