Lung Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Key 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

Key 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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT04832854

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 28 Locations for this study

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City of Hope Cancer Center; Division of Medical Oncology & Experimental Therapeutics
Duarte California, 91010, United States
City of Hope at Irvine Lennar
Irvine California, 92618, United States
University of Southern California
Los Angeles California, 90033, United States
Cedars Sinai Medical Center
Los Angeles California, 90048, United States
Georgetown U; Lombardi Comp Can
Washington District of Columbia, 20016, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Washington University School of Medicine; Medical Oncology
Saint Louis Missouri, 63110, United States
Winthrop Univ Hospital
Mineola New York, 11501, United States
NYU Cancer Center
New York New York, 10016, United States
Columbia University
New York New York, 10032, United States
Mays Cancer Center
San Antonio Texas, 78229, United States
Cabrini Hospital Malvern
Malvern Victoria, 3144, Australia
Kosin University Gospel Hospital
Busan , 49267, Korea, Republic of
St. Vincent's Hospital
Gyeonggi-do , 16247, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
Sabadell Barcelona, 8208, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña LA Coruña, 15006, Spain
Hospital Universitario Puerta de Hierro; Servicio de Oncologia
Majadahonda Madrid, 28222, Spain
Vall d´Hebron Institute of Oncology (VHIO), Barcelona
Barcelona , 08035, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Kantonsspital Baden; Medizinische Klinik, Onkologie
Baden , 5404, Switzerland
Universitaetsspital Basel; Onkologie
Basel , 4031, Switzerland
Inselspital Bern; Universitätsklinik für medizinische Onkologie
Bern , 3010, Switzerland
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
Chur , 7000, Switzerland
Kantonsspital St. Gallen; Onkologie/Hämatologie
St. Gallen , 9007, Switzerland
Kantonsspital Winterthur; Medizinische Onkologie
Winterthur , 8401, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich , 8091, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

82

Study ID:

NCT04832854

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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