Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-01-01 @ 12:13 PM
Study NCT ID:
NCT03977467
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2019-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atezolizumab and Tiragolumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor
Sponsor:
SCRI Development Innovations, LLC
Organization:
Study Overview
Official Title:
A Phase II Study of Atezolizumab and Tiragolumab in Patients With NSCLC or Advanced Solid Tumors Who Have Had Prior Treatment With a PD-1 Inhibitor
Status:
COMPLETED
Status Verified Date:
2025-08
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 a Phase II, two part trial (A and B), open label study of Atezolizumab and tiragolumab, or atezolizumab combined with SOC chemotherapy in patients with NSCLC or advanced solid tumors that have had prior treatment with a PD-1 inhibitor (e.g. nivolumab or pembrolizumab).
Detailed Description:
Arm A consists of approximately 20 patients with advanced NSCLC who received first-line anti-PD-1 therapy, who have subsequent disease progression. Arm B consists of approximately 15 patients per disease type (renal cell carcinoma \[RCC\] progressing on prior anti-PD-1 therapy, triple negative breast cancer \[TNBC\] progressing on prior anti-PD-1 therapy, NSCLC progressing on check-point inhibitors plus chemotherapy in the first-line setting; and microsatellite instability-high \[MSI-high\] solid tumors \[as determined by local testing for MSI/mismatch repair (MMR)\] progressing on prior anti-PD-1 therapy).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: