Lung Cancer Clinical Trial

A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Summary

This study will evaluate the safety and efficacy of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in chemotherapy-naive patients with locally advanced unresectable or metastatic PD-L1-selected non-small cell lung cancer (NSCLC), excluding patients with a sensitizing EGFR mutation or ALK translocation.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

ECOG Performance Status of 0 or 1
Histologically or cytologically documented locally advanced unresectable NSCLC, recurrent, or metastatic NSCLC of either squamous or non-squamous histology
No prior systemic treatment for locally advanced unresectable or metastatic NSCLC
Tumor PD-L1 expression
Measurable disease, as defined by RECIST v1.1
Life expectancy >=12 weeks
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating eggs
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion Criteria:

Cancer-Specific Exclusions:

Patients with NSCLC known to have a sensitizing mutation in the EGFR gene or an ALK fusion oncogene
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
Spinal cord compression not definitively treated with surgery and/or radiation, and/or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks prior to screening
History of leptomeningeal disease
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Uncontrolled tumor-related pain
Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome

General Medical Exclusions:

Pregnant and lactating women
Significant cardiovascular disease
Severe infections within 4 weeks prior to randomization
Major surgical procedure other than for diagnosis within 4 weeks prior to randomization

Treatment-Specific Exclusions:

History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
History of autoimmune disease
Prior allogeneic bone marrow transplantation or solid organ transplantation
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or active tuberculosis
Administration of a live, attenuated vaccine within 4 weeks prior to randomization

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

135

Study ID:

NCT03563716

Recruitment Status:

Active, not recruiting

Sponsor:

Genentech, Inc.

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There are 40 Locations for this study

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Arizona Oncology Associates, PC - HAL
Tempe Arizona, 85284, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
SCRI Florida Cancer Specialists North; Research Office North Region.
Saint Petersburg Florida, 33705, United States
Illinois Cancer Specialists
Arlington Heights Illinois, 60005, United States
Illinois Cancer Care
Peoria Illinois, 61615, United States
University of Kansas Medical Center
Westwood Kansas, 66205, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
HCA Midwest Health
Kansas City Missouri, 64132, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Virginia Cancer Specialists, PC
Fairfax Virginia, 22031, United States
Northwest Cancer Specialists - Vancouver
Vancouver Washington, 98684, United States
ICO Paul Papin; Oncologie Medicale.
Angers , 49055, France
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
Bordeaux , 33076, France
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
Dijon , 21000, France
Hopital Nord AP-HM; Service Clinique des bronches allergies et sommeil
Marseille , 13015, France
Institut De Cancerologie De L'Ouest; Medical Oncology
Saint Herblain , 44115, France
Chungbuk National University Hospital
Cheongju-si , 28644, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Kangbuk Samsung Hospital
Seoul , 03181, Korea, Republic of
Severance Hospital, Yonsei University Health System
Seoul , 03722, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Clinical Center of Serbia
Belgrade , 11000, Serbia
Clinical Hospital Center Bezanijska Kosa; Physical Medicine and Rehabilitation
Belgrade , 11070, Serbia
Institute of Lung Diseases Vojvodina
Sremska Kamenica , 21204, Serbia
Hospital Univ Germans Trias i Pujol
Badalona Barcelona, 8916, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria LAS Palmas, 35016, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda Madrid, 28220, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia
Pamplona Navarra, 31008, Spain
Hospital General Universitario de Alicante
Alicante , 03010, Spain
Hospital Universitari Vall d'Hebron; Oncology
Barcelona , 08035, Spain
Clinica Universitaria Navarra (Madrid)
Madrid , 28036, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia
Malaga , 29010, Spain
Centro Medico Quironsalud Sagrado Corazon
Sevilla , 41013, Spain
Hospital Universitario Virgen del Rocio
Sevilla , 41013, Spain
Taipei Medical University -Shuang Ho Hospital
New Taipei City , 23561, Taiwan
National Cheng Kung University Hospital; Internal Medicine
North Dist. , 70403, Taiwan
Taipei Veterans General Hospital
Taipei City , 112, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

135

Study ID:

NCT03563716

Recruitment Status:

Active, not recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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