Back to resultsA Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Primary Purpose
Non-small Cell Lung Cancer
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Tiragolumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
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
Sites / Locations
- Arizona Oncology Associates, PC - HAL
- SCRI Florida Cancer Specialists South
- SCRI Florida Cancer Specialists North; Research Office North Region.
- Illinois Cancer Specialists
- Illinois Cancer Care
- University of Kansas Medical Center
- Karmanos Cancer Institute
- HCA Midwest Health
- Sarah Cannon Research Institute
- Virginia Cancer Specialists, PC
- Northwest Cancer Specialists - Vancouver
- ICO Paul Papin; Oncologie Medicale.
- Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
- Centre Georges François Leclerc; Service Pharmacie, Bp 77980
- Hopital Nord AP-HM; Service Clinique des bronches allergies et sommeil
- Institut De Cancerologie De L'Ouest; Medical Oncology
- Chungbuk National University Hospital
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Kangbuk Samsung Hospital
- Severance Hospital, Yonsei University Health System
- Asan Medical Center
- Clinical Center of Serbia
- Clinical Hospital Center Bezanijska Kosa; Physical Medicine and Rehabilitation
- Institute of Lung Diseases Vojvodina
- Hospital Univ Germans Trias i Pujol
- Complejo Hospitalario Universitario Insular?Materno Infantil
- Hospital Universitario Puerta de Hierro - Majadahonda
- Clinica Universitaria de Navarra; Servicio de Oncologia
- Hospital General Universitario de Alicante
- Hospital Universitari Vall d'Hebron; Oncology
- Clinica Universitaria Navarra (Madrid)
- Hospital Universitario 12 de Octubre
- Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
- Centro Medico Quironsalud Sagrado Corazon
- Hospital Universitario Virgen del Rocio
- Taipei Medical University ?Shuang Ho Hospital
- National Cheng Kung University Hospital; Internal Medicine
- Taipei Veterans General Hospital
- National Taiwan University Hospital
- Chang Gung Memorial Hospital - Linkou
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo + Atezolizumab
Tiragolumab + Atezolizumab
Arm Description
Participants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Participants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
ORR, defined as a complete response (CR) or partial response (PR) on two consecutive occasions >/=4 weeks apart, as determined by the investigator according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Progression Free Survival (PFS)
PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
Secondary Outcome Measures
Duration of Objective Response (DOR)
DOR, defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
Overall Survival (OS)
OS, defined as the time from randomization to death from any cause.
Percentage of Participants With Adverse Events
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Serum Concentrations of Tiragolumab
Serum Concentrations of Atezolizumab
Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03563716
Brief Title
A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Official Title
A Phase II, Randomized, Blinded, Placebo-Controlled Study of Tiragolumab, An Anti-TIGIT Antibody, In Combination With Atezolizumab In Chemotherapy-Naïve Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo + Atezolizumab
Arm Type
Placebo Comparator
Arm Description
Participants will receive atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle and placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Arm Title
Tiragolumab + Atezolizumab
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab at a fixed dose of 1200 mg administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle and tiragolumab at a dose of 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq
Intervention Description
Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Tiragolumab
Other Intervention Name(s)
MTIG7192A
Intervention Description
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR, defined as a complete response (CR) or partial response (PR) on two consecutive occasions >/=4 weeks apart, as determined by the investigator according to RECIST v1.1. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR.
Time Frame
From baseline until a total of 80 progression free survival (PFS) events have occurred (up to approximately 11 months)
Title
Progression Free Survival (PFS)
Description
PFS, defined as the time from randomization to the first occurrence of disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
Time Frame
From baseline until a total of 80 PFS events have occurred (up to approximately 11 months)
Secondary Outcome Measure Information:
Title
Duration of Objective Response (DOR)
Description
DOR, defined as the time from the first occurrence of a documented objective response (CR or PR) to disease progression (PD), as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters at prior timepoints (including baseline).
Time Frame
Up to 5 years
Title
Overall Survival (OS)
Description
OS, defined as the time from randomization to death from any cause.
Time Frame
Up to 5 years
Title
Percentage of Participants With Adverse Events
Description
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame
Up to 5 years
Title
Serum Concentrations of Tiragolumab
Time Frame
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years).
Title
Serum Concentrations of Atezolizumab
Time Frame
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years).
Title
Percentage of Participants With Treatment-Emergent Anti-Drug Antibodies (ADAs)
Time Frame
Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 12 Day 1 (each cycle is 21 days), at treatment discontinuation visit (up to 5 years).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Oncology Associates, PC - HAL
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
SCRI Florida Cancer Specialists North; Research Office North Region.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Illinois Cancer Care
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
University of Kansas Medical Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
HCA Midwest Health
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Virginia Cancer Specialists, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Northwest Cancer Specialists - Vancouver
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
ICO Paul Papin; Oncologie Medicale.
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
Institut Bergonié Centre Régional de Lutte Contre Le Cancer de Bordeaux Et Sud Ouest
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Georges François Leclerc; Service Pharmacie, Bp 77980
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Hopital Nord AP-HM; Service Clinique des bronches allergies et sommeil
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Institut De Cancerologie De L'Ouest; Medical Oncology
City
Saint Herblain
ZIP/Postal Code
44115
Country
France
Facility Name
Chungbuk National University Hospital
City
Cheongju-si
ZIP/Postal Code
28644
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Bezanijska Kosa; Physical Medicine and Rehabilitation
City
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Institute of Lung Diseases Vojvodina
City
Sremska Kamenica
ZIP/Postal Code
21204
Country
Serbia
Facility Name
Hospital Univ Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Complejo Hospitalario Universitario Insular?Materno Infantil
City
Las Palmas de Gran Canaria
State/Province
LAS Palmas
ZIP/Postal Code
35016
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro - Majadahonda
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Clinica Universitaria Navarra (Madrid)
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Centro Medico Quironsalud Sagrado Corazon
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Taipei Medical University ?Shuang Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
National Cheng Kung University Hospital; Internal Medicine
City
North Dist.
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei City
ZIP/Postal Code
112
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
35576957
Citation
Cho BC, Abreu DR, Hussein M, Cobo M, Patel AJ, Secen N, Lee KH, Massuti B, Hiret S, Yang JCH, Barlesi F, Lee DH, Ares LP, Hsieh RW, Patil NS, Twomey P, Yang X, Meng R, Johnson ML. Tiragolumab plus atezolizumab versus placebo plus atezolizumab as a first-line treatment for PD-L1-selected non-small-cell lung cancer (CITYSCAPE): primary and follow-up analyses of a randomised, double-blind, phase 2 study. Lancet Oncol. 2022 Jun;23(6):781-792. doi: 10.1016/S1470-2045(22)00226-1. Epub 2022 May 13.
Results Reference
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A Study of Tiragolumab in Combination With Atezolizumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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