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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    55
  • sponsor
    MedPacto, Inc.
Updated on 29 January 2021

Summary

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.

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).

Details
Condition Non-Small Cell Lung Cancer
Treatment Vactosertib 300 mg BID and pembrolizumab 200 mg IV
Clinical Study IdentifierNCT04515979
SponsorMedPacto, Inc.
Last Modified on29 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 19 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Non-Small Cell Lung Cancer??
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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