Study on Tomivosertib and Pembrolizumab for Patients with PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Effector Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04622007

Provider View

This clinical trial is testing a combination of the drugs Tomivosertib and Pembrolizumab to see if they can effectively treat patients with PD-L1 positive Non-Small Cell Lung Cancer (NSCLC).

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness of combining Tomivosertib with Pembrolizumab in treating patients with PD-L1 positive Non-Small Cell Lung Cancer (NSCLC). It is designed for patients who are either starting their first treatment or whose cancer has progressed after initial treatment with Pembrolizumab alone.

Description

This trial is a randomized, double-blind, placebo-controlled study. It investigates the use of Tomivosertib in combination with Pembrolizumab, an anti-PD-(L)1 therapy, for patients with Non-Small Cell Lung Cancer (NSCLC). The study is for patients who are either receiving their first treatment or whose cancer has progressed after initial treatment with Pembrolizumab alone. The goal is to determine if this combination can improve treatment outcomes.

Eligibility Criteria

Inclusion Criteria

  • For Cohort A:

    • Started first-line treatment for NSCLC with Pembrolizumab.
    • Tumor shows PD-L1 levels of 1% or higher.
    • Tolerating Pembrolizumab well.
    • Been on Pembrolizumab for at least 3 months.
    • Recent scans show cancer progression.
    • Previous scans showed stable disease or improvement.

  • For Cohort B:

    • Eligible for Pembrolizumab alone for advanced/metastatic NSCLC.
    • Tumor shows PD-L1 levels of 50% or higher.
    • Not previously treated with platinum-based chemotherapy for advanced/metastatic cancer.

  • For Cohort C:

    • Completed initial chemotherapy with Pembrolizumab.
    • Eligible for maintenance therapy with Pembrolizumab, with or without Pemetrexed.
    • Tumor shows PD-L1 levels of 1% or higher.
    • Last chemotherapy dose within 8 weeks of starting the study drug.

  • For All Cohorts:

    • Confirmed diagnosis of inoperable, advanced, or metastatic NSCLC.
    • Tumor sample available for testing.
    • Provided written informed consent.
    • Aged 18 or older.
    • ECOG performance status of 0 or 1.

Exclusion Criteria

  • Have NSCLC with specific genetic changes (EGFR or ALK mutations).
  • Have gastrointestinal issues that could affect drug absorption or cause side effects.
  • Have symptomatic brain metastases requiring high doses of steroids. Patients with treated brain metastases may be eligible if stable and not requiring high steroid doses.

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