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

NCT ID: NCT04832854

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-23
• Study Completion Date: 2025-03-05

Brief 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)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort A (PD-L1 High)

Participants with high programmed death-ligand 1 (PD-L1) expression level will be enrolled in Cohort A and receive neoadjuvant atezolizumab plus tiragolumab for 4 cycles, followed by surgical resection and either adjuvant atezolizumab plus tiragolumab for 16 cycles or adjuvant chemotherapy for 4 cycles at the discretion of the investigator.

Chemotherapy may include:

• cisplatin/carboplatin + pemetrexed (for non-squamous only)
• carboplatin + gemcitabine (for squamous only)
• carboplatin + paclitaxel

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Tiragolumab

Intervention Type: DRUG

Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.

Carboplatin

Intervention Type: DRUG

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.

Cisplatin

Intervention Type: DRUG

Cisplatin at 75 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Pemetrexed

Intervention Type: DRUG

Pemetrexed at 500 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Gemcitabine

Intervention Type: DRUG

Gemcitabine at 1000 or 1250 mg/m\^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.

Paclitaxel

Intervention Type: DRUG

Paclitaxel at 175 or 200 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Cohort B (PD-L1 All Comers)

All comers, which are participants with any PD-L1 expression level, will be enrolled in Cohort B and receive neoadjuvant atezolizumab plus tiragolumab plus chemotherapy for 4 cycles, followed by surgical resection and adjuvant atezolizumab plus tiragolumab for 16 cycles.

Chemotherapy may include:

• cisplatin/carboplatin + pemetrexed (for non-squamous only)
• carboplatin + gemcitabine (for squamous only)
• carboplatin + paclitaxel

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Tiragolumab

Intervention Type: DRUG

Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.

Carboplatin

Intervention Type: DRUG

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.

Cisplatin

Intervention Type: DRUG

Cisplatin at 75 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Pemetrexed

Intervention Type: DRUG

Pemetrexed at 500 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Gemcitabine

Intervention Type: DRUG

Gemcitabine at 1000 or 1250 mg/m\^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.

Paclitaxel

Intervention Type: DRUG

Paclitaxel at 175 or 200 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Interventions

Atezolizumab

Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Intervention Type: DRUG

Tiragolumab

Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.

Intervention Type: 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.

Intervention Type: DRUG

Cisplatin

Cisplatin at 75 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Intervention Type: DRUG

Pemetrexed

Pemetrexed at 500 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Intervention Type: 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.

Intervention Type: DRUG

Paclitaxel

Paclitaxel at 175 or 200 mg/m\^2 will be administered by IV infusion on Day 1 of each 21-day cycle.

Intervention Type: DRUG

Other Intervention Names

Tecentriq; MTIG7192A

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed Stage II, IIIA, or select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology
• Eligible for R0 resection with curative intent at the time of screening
• Adequate pulmonary function to be eligible for surgical resection with curative intent
• Eligible to receive a platinum-based chemotherapy regimen
• Measurable disease, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Availability of a representative tumor specimen that is suitable for determination of PD-L1 status
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Normal life expectancy, excluding lung cancer mortality risk
• Adequate hematologic and end-organ function
• Negative human immunodeficiency virus (HIV) test at screening
• Negative serology for active hepatitis B virus (HBV) and active hepatitis C virus (HCV) at screening

Exclusion Criteria

• NSCLC with histology of large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or NSCLC not otherwise specified
• Small cell lung cancer (SCLC) histology or NSCLC with any component of SCLC
• Any prior therapy for lung cancer
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Active tuberculosis
• Significant cardiovascular disease
• NSCLC with an activating EGFR mutation or ALK fusion oncogene
• Known c-ros oncogene 1 (ROS1) rearrangement
• History of malignancy other than NSCLC within 5 years prior to screening, with the exception of malignancies with negligible risk of metastasis or death
• Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
• Prior treatment with CD127 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-TIGIT, and anti-PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents
• Treatment with systemic immunosuppressive medication
• Pregnancy or breastfeeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

City of Hope Cancer Center

Duarte, California, United States

City of Hope at Irvine Lennar

Irvine, California, United States

University of Southern California

Los Angeles, California, United States

Washington University School of Medicine

St Louis, Missouri, United States

Winthrop Univ Hospital

Mineola, New York, United States

NYU Cancer Center

New York, New York, United States

Columbia University

New York, New York, United States

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Peter Maccallum Cancer Institute

Melbourne, Victoria, Australia

St. Vincent's Hospital

Gyeonggi-do, , South Korea

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

ICO L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, , Spain

Vall d?Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Kantonsspital Baden

Baden, , Switzerland

Kantonsspital Graubünden Medizin Onkologie

Chur, , Switzerland

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

UniversitätsSpital Zürich

Zurich, , Switzerland

Countries

United States; Australia; South Korea; Spain; Switzerland

Other Identifiers

2020-002853-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO42501

Identifier Type: -

Identifier Source: org_study_id