Status:
TERMINATED
Vactosertib in Combination with Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects
Lead Sponsor:
MedPacto, Inc.
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 pos...
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 accor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04515979
Start Date
December 17 2020
End Date
August 5 2024
Last Update
December 9 2024
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351