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Tomivosertib for Non Small Cell Lung Cancer (KICKSTART Trial)
KICKSTART Trial Summary
This trial will test a new combination treatment for lung cancer.
- Non-Small Cell Lung Cancer
KICKSTART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTomivosertib Efficacy
Tumors treated with both Tomivosertib and a Keytruda-equivalent halt all growth in mammal testing.
No treatment
Keytruda-equivalent
Tomivosertib
Keytruda-eq + Tomivosertib
Tumor Volume (mm³)
Drug dosage
Tomivosertib Efficacy
Mice with non-small cell lung cancer live far longer when treated with Tomivosertib.
No treatment
Tomivosertib
Percent Survival %
Days post treatment
KICKSTART Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.KICKSTART Trial Design
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Who is running the clinical trial?
Media Library
- You have advanced or metastatic non-small cell lung cancer and your tumor tests positive for PD-L1 with a score of 50 or more. You also meet the requirements for treatment with pembrolizumab.Answer YES if you have not been treated with platinum-based chemotherapy (e.g., cisplatin, carboplatin, and oxaliplatin)Can you move around easily and do light work during the day? Answer YES or NO.The doctors need to review the two most recent scans, which show that your condition is getting worse.Do you have a tumor PD-L1 that is at least 50%? PD-L1 protein prevents immune cells from attacking harmless cells. Check your biomarker test results for PD-L1 level.Have you ever received platinum-based chemotherapy before? If your answer is no, then you are eligible.The first scan taken at least 21 days after you received anti-PD-(L)1 therapy must show that your disease has not gotten worse (no Progressive Disease) according to the RECIST 1.1 criteria.Answer YES if you do not have Non Small Cell Lung Cancer with ALK or EGFR mutationsAnswer YES if you are mobile and able to carry out light work throughout your dayHave you been diagnosed with metastatic Non Small Cell Lung Cancer (Stage 3b/4)?You do not have a specific type of lung cancer called Non Small Cell Lung Cancer with ALK or EGFR mutations.You are eligible to participate in Cohort B.Have you never received platinum-based chemotherapy like cisplatin, carboplatin, or oxaliplatin? If yes, answer YES.Your tumor must have a certain level of the protein PD-L1 (at least 50%). A test called biomarker testing can determine if you meet this requirement.You have non-small cell lung cancer and have received a certain type of treatment called IL therapy with platinum-based chemotherapy and pembrolizumab. You must have completed the planned chemotherapy without any signs of the cancer getting worse.You have been taking pembrolizumab for at least 3 months and your most recent scans show that your disease has started to get worse according to specific criteria called RECIST 1.1.Your tumor must have a PD-L1 level of at least 50%.The lead doctor has determined that you can handle treatment with only pembrolizumab.You can receive pembrolizumab with or without pemetrexed as part of your ongoing treatment plan.You do not have Non Small Cell Lung Cancer with certain genetic mutations called ALK or EGFR.
- Group 1: B1 Tomi + Pembro
- Group 2: A1 Tomi + Current Pembro
- Group 3: Pbo + Pembro
- Group 4: C1 Tomi + Pembro + Pemetrexed (Non-sqamous) or Tomi + Pembro (Squamous)
- Group 5: Pbo + Current Pembro
- Group 6: Pbo + Pembro + Pemetrexed (Non-sqamous) or Pbo + Pembro (Squamous)
- Screening: It may take up to 28 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 21 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Months after you stop receiving the treatment.
Frequently Asked Questions
How many centers are providing access to this clinical experiment?
"This clinical trial is currently enrolling participants at 84 centres, which includes Abilene, Brooksville and Morgantown as well as 81 other sites. To reduce the burden of travel expenses, it may be beneficial to select a location nearest you when considering participation."
How many participants is this experiment enrolling in total?
"To complete this medical trial, 180 volunteers who meet the pre-determined criteria must be enrolled. Potential participants can find a clinical site in Abilene, Texas or Brooksville, West virginia that offers participation opportunities at Texas Oncology - West Texas and ASCLEPES Research Centers respectively."
Are enrollment slots still available for this experiment?
"Affirmative. The clinicaltrials.gov database indicates that this medical research effort, first listed on June 2nd 2021, is presently recruiting patients. A total of 180 individuals must be gathered from 83 sites in order to complete the study's requirements."
To what maladies is Tomivosertib commonly prescribed?
"Tomivosertib is prescribed for the treatment of malignant neoplasms and can be used to battle conditions like unresectable melanoma, microsatellite instability high, or chemotherapy-resistant progression."
What is the aim of this clinical research?
"This two-year long medical trial aims to measure the progression-free survival (PFS) of tomivosertib when taken in conjunction with pembrolizumab as first line treatment. Secondary objectives include evaluating PFS in combination with pemetrexed and/or pembrolizumab, depending on if a patient has non-squamous or squamous NSCLC, respectively; likewise these results will be measured by assessing RECIST 1.1 response data collected by the BIRC. Additionally, each cohort (A,B & C) which are receiving different treatments involving tomivosertib plus p"
Has Tomivosertib been evaluated in other research studies?
"Tomivosertib commenced research at City of Hope a decade ago, with 381 studies completed to date. Currently there are 961 ongoing projects, the majority of which take place in Abilene, Texas."
To what extent are individuals safeguarded when taking Tomivosertib?
"Tomivosertib has been evaluated with regards to safety, and is estimated as a score of 2 on the scale. This rating indicates that while it may not be proven efficacious yet, there is data indicating its level of security."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Henry Ford Hospital: < 24 hours
- Columbia University: < 24 hours
- Providence Portland Medical Center: < 24 hours
Average response time
- < 2 Days
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