NCT04832854

A Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Participants With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the surgical safety and feasibility of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment for participants with previously untreated locally advanced non-small cell lung cancer (NSCLC). The study will also evaluate the efficacy, pharmacokinetics, immunogenicity, and safety of atezolizumab plus tiragolumab alone or in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by adjuvant atezolizumab plus tiragolumab or adjuvant platinum-based chemotherapy.

Conditions

• Non-Small Cell Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Atezolizumab	Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.
DRUG	Tiragolumab	Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
DRUG	Carboplatin	Carboplatin at initial target area under the concentration curve (AUC) of 5 or 6 mg/mL/min will be administered by IV infusion on Day 1 of each 21-day cycle.
DRUG	Cisplatin	Cisplatin at 75 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
DRUG	Pemetrexed	Pemetrexed at 500 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
DRUG	Gemcitabine	Gemcitabine at 1000 or 1250 mg/m\^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.
DRUG	Paclitaxel	Paclitaxel at 175 or 200 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Timeline

• Start date: 2021-04-23
• Primary completion: 2025-03-05
• Completion: 2025-03-05
• First posted: 2021-04-06
• Last updated: 2026-03-11
• Results posted: 2026-03-11

Locations

21 sites across 5 countries: United States, Australia, South Korea, Spain, Switzerland

Regulatory

• FDA-regulated drug study