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Tomivosertib for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Texas Oncology - West Texas, Abilene, TXVerifiedNon-Small Cell Lung CancerTomivosertib - Drug
Eligibility
18 - No maximum age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new combination treatment for lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Pemetrexed (Chemotherapy)
1
Binimetinib
1
Selpercatinib

Study Objectives

4 Primary · 7 Secondary · Reporting Duration: 2 years

2 years
To characterize the PFS of tomivosertib when added to pembrolizumab after first radiographic progression on pembrolizumab monotherapy
To characterize the PFS of tomivosertib when added to pembrolizumab after first radiographic progression on pembrolizumab monotherapy.
To characterize the PFS of tomivosertib when added to pembrolizumab after first radiographic progression on pembrolizumab monotherapy;
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.
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.
To characterize the PFS of tomivosertib when added to pembrolizumab as a first-line treatment in subjects with NSCLC
To characterize the PFS of tomivosertib when added to pembrolizumab as a first-line treatment in subjects with NSCLC;
Therapeutic procedure
To characterize the PFS of tomivosertib when added to pembrolizumab in Cohorts A and B combined;
To characterize the PFS of tomivosertib when added to pembrolizumab in Cohorts A, B, and B C individually and combined
To characterize the progression-free survival (PFS) of tomivosertib when added to pembrolizumab as a first-line treatment;

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Pemetrexed (Chemotherapy)
1
Binimetinib
2
Selpercatinib

Trial Design

7 Treatment Groups

Tomi + Current Pembro
1 of 7
A1 Tomi + Current Pembro
1 of 7
B1 Tomi + Pembro
1 of 7
C1 Tomi + Pembro + Pemetrexed (Non-sqamous) or Tomi + Pembro (Squamous)
1 of 7
Pbo + Current Pembro
1 of 7
Pbo + Pembro
1 of 7
Pbo + Pembro + Pemetrexed (Non-sqamous) or Pbo + Pembro (Squamous)
1 of 7

Experimental Treatment

Non-Treatment Group

180 Total Participants · 7 Treatment Groups

Primary Treatment: Tomivosertib · Has Placebo Group · Phase 2

Tomi + Current PembroExperimental Group · 2 Interventions: Tomivosertib, Pembrolizumab · Intervention Types: Drug, Biological
A1 Tomi + Current PembroExperimental Group · 2 Interventions: Tomivosertib, Pembrolizumab · Intervention Types: Drug, Biological
B1 Tomi + PembroExperimental Group · 2 Interventions: Tomivosertib, Pembrolizumab · Intervention Types: Drug, Biological
C1 Tomi + Pembro + Pemetrexed (Non-sqamous) or Tomi + Pembro (Squamous)Experimental Group · 3 Interventions: Tomivosertib, Pembrolizumab, Pemetrexed · Intervention Types: Drug, Biological, Drug
Pbo + Current Pembro
Biological
PlaceboComparator Group · 1 Intervention: Pembrolizumab · Intervention Types: Biological
Pbo + Pembro
Biological
PlaceboComparator Group · 1 Intervention: Pembrolizumab · Intervention Types: Biological
Pbo + Pembro + Pemetrexed (Non-sqamous) or Pbo + Pembro (Squamous)PlaceboComparator Group · 2 Interventions: Pembrolizumab, Pemetrexed · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Pemetrexed
2014
Completed Phase 3
~4270

Trial Logistics

Trial Timeline

Screening: 1 Weeks
Treatment: 24 Months
Reporting: 2 years

Who is running the clinical trial?

Effector TherapeuticsLead Sponsor
9 Previous Clinical Trials
491 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
89 Previous Clinical Trials
28,439 Total Patients Enrolled
Douglas Warner, MDStudy DirectoreFFECTOR Therapeutics, Inc.
2 Previous Clinical Trials
264 Total Patients Enrolled
Premal Patel, MD, Ph.D.Study DirectorEffector Therapeutics
Robert Sikorski, MD, Ph.D.Study DirectoreFFECTOR Therapeutics, Inc.

Eligibility Criteria

Age 18 - No maximum age · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Have you been diagnosed with metastatic Non Small Cell Lung Cancer (Stage 3b/4)?
Answer YES if you are mobile and able to carry out light work throughout your day
Answer YES if you do not have Non Small Cell Lung Cancer with ALK or EGFR mutations
Answer YES if you have not been treated with platinum-based chemotherapy (e.g., cisplatin, carboplatin, and oxaliplatin)
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.

Who else is applying?

What state do they live in?
Texas75.0%
Florida25.0%
How old are they?
65+66.7%
18 - 6533.3%
What site did they apply to?
Texas Oncology-Baylor Charles A. Sammons Cancer Center66.7%
Memorial Healthcare System33.3%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
050.0%
150.0%
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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