Back to resultsVactosertib in Combination With Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects
Primary Purpose
Carcinoma, Non-Small-Cell Lung
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vactosertib 300 mg BID and pembrolizumab 200 mg IV
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung
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
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vactosertib+Pembrolizumab
Arm Description
Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks
Outcomes
Primary Outcome Measures
ORR per RECIST 1.1
ORR in PD-L1≥1% and PD-L1≥50% population per RECIST 1.1 by investigators
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04515979
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedPacto, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-Small-Cell Lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vactosertib+Pembrolizumab
Arm Type
Experimental
Arm Description
Vactosertib (5days on and 2days off) Pembrolizumab 200mg Q3Weeks
Intervention Type
Drug
Intervention Name(s)
Vactosertib 300 mg BID and pembrolizumab 200 mg IV
Intervention Description
Vactosertib 300 mg orally (PO) BID(5 days on/2days off) and pembrolizumab 200 mg IV (Q3W).
Primary Outcome Measure Information:
Title
ORR per RECIST 1.1
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
kyounghee kim
Phone
82-2-6938-0235
Email
kyounghee.kim@medpacto.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bitna Oh, MD
Organizational Affiliation
MedPacto, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sㄷ-hoon Lee, Phd
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vactosertib in Combination With Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer (NSCLC) Subjects
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