NCT03977467

Atezolizumab and Tiragolumab in Patients With NSCLC or Advanced Solid Tumors Having Had Prior Treatment With a PD-1 Inhibitor

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Non-Small Cell Lung Cancer
• Solid Tumor

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab at a flat dose of 1200 mg IV every 3 weeks
DRUG	Standard of Care Chemotherapy	Platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. It should be administered according to the directions in the approved labeling.
DRUG	Tiragolumab	Tiragolumab at a flat dose of 600 mg IV every 3 weeks

Timeline

• Start date: 2019-08-30
• Primary completion: 2024-08-09
• Completion: 2024-08-09
• First posted: 2019-06-06
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study