Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04515979
Status:
RECRUITING
Last Update Posted:
2021-09-24
First Post:
2020-08-11
Brief Title:
Vactosertib in Combination With Pembrolizumab for PD-L1 Positive Non-small Cell Lung Cancer NSCLC Subjects
Sponsor:
MedPacto Inc
Organization:
MedPacto Inc
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 on2days off and pembrolizumab 200 mg IV on Day 1 of every 3-week cycle Q3W
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 on2days off and pembrolizumab 200 mg IV on Day 1 of every 3-week cycle Q3W
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MK3475 B37 | OTHER | Merck | None |