What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), such as Pembrolizumab (a PD-1 inhibitor), are associated with immune-related adverse effects including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Severe adverse effects can include severe pneumonitis and colitis. When combined with chemotherapy, additional side effects like nausea, vomiting, fatigue, neutropenia, and increased infection risk are common. Combining these treatments can increase the incidence of adverse effects, requiring careful monitoring and management.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has received FDA approval for the treatment of advanced NSCLC, particularly in patients with high PD-L1 expression (≥50%). It is often used in combination with chemotherapy for better efficacy. Other PD-1 inhibitors like nivolumab and cemiplimab have also been approved for similar indications. Nivolumab is approved for use with ipilimumab, a CTLA-4 inhibitor, in first-line treatment for metastatic NSCLC. Atezolizumab, another PD-1 inhibitor, is approved for use in patients with high PD-L1 expression and in combination with chemotherapy for broader patient populations.

What other types of research exist?

Promising alternatives include: 1) Aumolertinib for patients with EGFR-sensitive mutations after osimertinib failure. 2) Combination of BRAF inhibitors with immunotherapy or ERK inhibitors for BRAF-mutant NSCLC. 3) HKI-272 combined with rapamycin for EGFR T790M mutations. 4) Selumetinib for KRAS mutant NSCLC. 5) Entrectinib for ALK-rearranged NSCLC.

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Tomivosertib for Non Small Cell Lung Cancer (KICKSTART Trial)

Verified Trial

Phase 2

Waitlist Available

Research Sponsored by Effector Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Timeline

Screening 28 weeks

Treatment 21 months

Follow Up 0 days

Summary

This trial tests a combination of two drugs, Tomivosertib and pembrolizumab, in patients with a specific type of lung cancer. Pembrolizumab is a targeted therapy that has been approved for treating this type of cancer. The trial aims to enhance the immune system's ability to fight cancer, especially in those who haven't been treated yet or whose cancer has worsened despite previous treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Tomivosertib 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

Timeline

Screening ~ 28 weeks3 visits

Treatment ~ 21 months24 visits

Follow Up ~ 0 days0 visits

Screening ~ 28 weeks

Treatment ~ 21 months

Follow Up ~0 days

This trial's timeline: 28 weeks for screening, 21 months for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 first line therapy.

To characterize the progression-free survival (PFS) of tomivosertib when added to pembrolizumab as a first-line treatment;

Secondary study objectives

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 as a first-line treatment in subjects with NSCLC

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: C1 Tomi + Pembro + Pemetrexed (Non-sqamous) or Tomi + Pembro (Squamous)Experimental Treatment3 Interventions

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.

Group II: B1 Tomi + PembroExperimental Treatment2 Interventions

Subjects will initiate pembrolizumab as first-line therapy and receive tomivosertib.

Group III: A1 Tomi + Current PembroExperimental Treatment2 Interventions

Subjects who have initiated pembrolizumab as a single agent and in accordance with the package insert will receive tomivosertib in addition to pembrolizumab.

Group IV: Pbo + PembroPlacebo Group1 Intervention

Subjects will initiate pembrolizumab as first-line therapy and receive matching placebo.

Group V: Pbo + Current PembroPlacebo Group1 Intervention

Subjects who have initiated pembrolizumab as a single agent and in accordance with the package insert, will receive matching placebo in addition to pembrolizumab.

Group VI: Pbo + Pembro + Pemetrexed (Non-sqamous) or Pbo + Pembro (Squamous)Placebo Group2 Interventions

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Pemetrexed

2014

Completed Phase 3

~5550

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors like Pembrolizumab and kinase inhibitors such as Tomivosertib. Pembrolizumab blocks the PD-1 pathway, reactivating T-cells to attack cancer cells, while Tomivosertib inhibits MNK1/2 kinases, which are involved in cancer cell survival and proliferation. Combining these treatments enhances the immune response and inhibits cancer cell growth, offering a comprehensive strategy that may improve outcomes and survival rates for NSCLC patients.

New targeted treatments in lung cancer--overview of clinical trials.