NCT05746481

Tiragolumab and Atezolizumab in Patients With Non-squamous Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases

A Phase II Clinical Trial of Tiragolumab in Combination With Atezolizumab in Patients With Non-small Cell Lung Cancer (NSCLC) and Untreated Brain Metastases.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Liza Villaruz, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is aimed at the evaluation of the safety and clinical activity of tiragolumab in combination with atezolizumab with or without chemotherapy in the first line treatment of metastatic non-squamous NSCLC patients with asymptomatic untreated brain metastases.

Detailed description

This is a phase II clinical trial aimed at the evaluation of the safety and clinical activity of tiragolumab in combination with atezolizumab with or without chemotherapy in the first line treatment of metastatic non-squamous NSCLC patients with asymptomatic untreated brain metastases. Patients with at least one untreated evaluable brain metastasis of 5 mm or more will be enrolled. Lesions previously treated with SRS may not be used as target lesions. Patients will be required to undergo an on-treatment brain MRI at three weeks for safety purposes. Additional restaging will occur at nine-week intervals. PD-L1 tumor proportion score (TPS) will be determined utilizing an FDA-approved test by local testing.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Tiragolumab	Tiragolumab (an investigational novel immune checkpoint inhibitor): 600 mg IV for induction treatment administered on Day 1 of each 21-day cycle for 4 cycles. Maintenance therapy will continue with tiragolumab on Day 1 of each 21-day cycle.
DRUG	Atezolizumab	Atezolizumab (monoclonal antibody): 1200 mg IV administered on Day 1 of each 21-day cycle.
DRUG	Pemetrexed	Pemetrexed (antifolate antineoplastic agent chemotherapy): 500 mg/m2 administered IV on Day 1 of each 21-day cycle.
DRUG	Carboplatin	Carboplatin AUC 5 (alkylating agent chemotherapy): injection administered on Day 1 of each 21-day cycle.

Timeline

• Start date: 2023-08-10
• Primary completion: 2024-08-19
• Completion: 2025-11-08
• First posted: 2023-02-27
• Last updated: 2026-01-22
• Results posted: 2026-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study