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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04515979
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : September 24, 2021
Information provided by (Responsible Party):
MedPacto, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 17, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: vactosertib+Pembrolizumab
Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks
Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV
Vactosertib 300 mg orally (PO) BID(5 days on/2days off) and pembrolizumab 200 mg IV (Q3W).

Primary Outcome Measures :
  1. 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 ]
    ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04515979

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Contact: kyounghee kim 82-2-6938-0235

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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Sㄷ-hoon Lee, Phd         
Sponsors and Collaborators
MedPacto, Inc.
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Study Director: Bitna Oh, MD MedPacto, Inc.
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Responsible Party: MedPacto, Inc. Identifier: NCT04515979    
Other Study ID Numbers: MP-VAC-205
MK3475 B37 ( Other Identifier: Merck )
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents