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TerminatedNCT04515979Updated Dec 9, 2024

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

A Phase 2 interventional study of Vactosertib 300 mg BID and pembrolizumab 200 mg IV in Carcinoma, Non-Small-Cell Lung, sponsored by MedPacto, Inc.. Terminated at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by MedPacto, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
This is because Medpacto decided to modify its development strategy as the business and development environment changed.
Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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).
02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 11 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

MedPacto, Inc. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Experimental
    vactosertib+Pembrolizumab

    Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks

    Drug: Vactosertib 300 mg BID and pembrolizumab 200 mg IV

Interventions

  • DrugVactosertib 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).

    Also known as: Vactosertib 300 mg BID and keytruda 200 mg IV

06

What researchers measure

Primary outcomes

  1. ORR per RECIST 1.1

    ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators

    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

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 06351, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04515979
Lead sponsor
MedPacto, Inc.
Responsible party
Sponsor
First posted
Aug 17, 2020
Start date
Dec 17, 2020
Primary completion
Aug 5, 2024
Completion
Aug 5, 2024
Last update
Dec 9, 2024

Study contacts

Minkyu Heo
study director · MedPacto, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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