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

NCT04622007 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-04-30

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Tomivosertib

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

BIOLOGICAL

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.

DRUG

Pemetrexed

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

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • ICON plc

    collaborator INDUSTRY

  • Effector Therapeutics

    lead INDUSTRY

Principal Investigators

  • Douglas Warner, MD · EFFECTOR Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-02
Primary Completion
2024-10-14
Completion
2024-12-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Georgia

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04622007 on ClinicalTrials.gov