Clinical Trials /

Vactosertib in Combination With Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects

NCT04515979

Description:

This is Phase 2, open label, multi-center study to assess safety and efficacy of vactosertib in combination with pembrolizumab as 1st line treatment for subjects with advanced or metastatic, PD-L1 positive, non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom EGFR, ALK, BRAF, ROS1-directed therapy is not indicated.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Vactosertib in Combination With Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects
  • Official Title: A Phase 2, Open-label, Multicenter Study to Assess the Efficacy and Safety of Vactosertib in Combination With Pembrolizumab as a First-line Treatment for Subjects With PD-L1 Positive Advanced Non-Small Cell Lung Cancer

Clinical Trial IDs

  • ORG STUDY ID: MP-VAC-205
  • SECONDARY ID: MK3475 B37
  • NCT ID: NCT04515979

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DrugSynonymsArms
Vactosertib 300 mg BID and pembrolizumab 200 mg IVvactosertib+Pembrolizumab

Purpose

This is Phase 2, open label, multi-center study to assess safety and efficacy of vactosertib in combination with pembrolizumab as 1st line treatment for subjects with advanced or metastatic, PD-L1 positive, non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom EGFR, ALK, BRAF, ROS1-directed therapy is not indicated.

Detailed Description

      Approximately 55 NSCLC subjects with PD-L1 tumor proportion score (TPS) ≥ 1% are expected to
      be enrolled in this study. Subjects' TPS will be determined by PD-L1 IHC 22C3 pharmDx assay
      performed according to local laboratory regulations prior to study enrollment.

      Subjects who received adjuvant or neoadjuvant therapy are permitted onto the study if the
      therapy was completed at least 12 months prior to the development of metastatic disease.

      Eligible subjects will receive:

      • Vactosertib 300 mg orally (PO) BID for 5 days with 2 days off period (5 days on/2days off)
      and pembrolizumab 200 mg IV on Day 1 of every 3-week cycle (Q3W).
    

Trial Arms

NameTypeDescriptionInterventions
vactosertib+PembrolizumabExperimentalVactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks
  • Vactosertib 300 mg BID and pembrolizumab 200 mg IV

Eligibility Criteria

        Inclusion Criteria:

          -  Have a histologically- or cytologically-documented NSCLC advanced or stage IV lung
             cancer

          -  Have confirmation that EGFR, ALK, BRAF, ROS1-directed therapy is not indicated

          -  Have measurable disease based on RECIST 1.1

          -  PD-L1 expression is ≥1% as determined by the PD-L1 IHC 22C3 pharmDx assay

          -  Have a life expectancy of at least 3 months.

          -  ECOG 0 or 1

          -  Subjects must be able to swallow tablets and absorb vactosertib.

          -  Have adequate organ function as indicated by the following laboratory values in

        Exclusion Criteria:

          -  Is currently participating in a study of an investigational agent

          -  Has received prior systemic cytotoxic chemotherapy for metastatic disease/
             antineoplastic biological therapy /Had major surgery / radiation therapy to the lung

          -  Has received a live vaccine within 30 days prior to the first dose of study drug.

          -  Is taking prohibited medications

          -  Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

          -  Has known active central nervous system (CNS) metastases and/or carcinomatous
             meningitis.

          -  Had a severe hypersensitivity reaction to treatment with another mAb previously.

          -  Has severe hypersensitivity to vactosertib and/or any of its excipients
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:ORR per RECIST 1.1
Time Frame:From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
Safety Issue:
Description:ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:MedPacto, Inc.

Last Updated

August 13, 2020