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Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (ARC-7)

Primary Purpose

Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Domvanalimab
Etrumadenant
Zimberelimab
Sponsored by
Arcus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring Non Small Cell Lung Cancer, Lung Cancer, NSCLC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female participants; age ≥ 18 years
  • Histologically confirmed, treatment naïve, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Must have at least 1 measurable lesion per RECIST v1.1
  • Adequate organ and marrow function

Exclusion Criteria:

  • Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)
  • Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)
  • History of trauma or major surgery within 28 days prior to the first dose of IMP
  • Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications
  • Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening
  • Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
  • Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer

Sites / Locations

  • University of Alabama at Birmingham
  • Pacific Cancer Medical Center, Inc
  • Innovative Clinical Research Institute (ICRI)
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists
  • Florida Cancer Specialists - Panhandle
  • Florida Cancer Specialists - East
  • Baptist Health Lexington
  • Norton Cancer Institute
  • Baptist Hospital East
  • Ochsner Clinic Foundation
  • American Oncology Partners of Maryland, PA
  • Detroit Clinical Research Center, PC
  • Hattiesburg Clinic
  • Comprehensive Cancer Centers Of Nevada
  • The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
  • Clinical Research Alliance
  • Northwell Health Cancer Institute
  • Wake Forest Baptist Health
  • Allegheny General Hospital (AGH)-Alleghney Singer Research Institute
  • Prisma Health-Upstate
  • Sarah Cannon Research Institute
  • The Center For Cancer And Blood Disorders (Texas Cancer Care)
  • Dr.John R Waldron, MD Off of
  • Joe Arrington Cancer Research and Treatment Center
  • Tyler Hematology-Oncology, P.A.
  • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
  • Virginia Cancer Specialists
  • Border Medical Oncology
  • Coffs Harbour Health Campus
  • Shoalhaven Cancer Care Centre
  • Tweed Hospital
  • Adelaide Cancer Centre
  • Brampton Civic Hospital (Bch), William Osler Health Centre
  • McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH)
  • Centre Integre de Sante et de Services Sociaux des Laurentides Hopital regional de Saint-Jerome
  • Hong Kong United Oncology Centre
  • Humanity and Health Research Center
  • Princess Margaret Hospital
  • Queen Elizabeth Hospital (Hong Kong)
  • Kosin University Gospel Hospital
  • Chonnam University Hospital
  • Gachon University Gil Medical Center
  • Chonbuk National University Hospital
  • Seoul National University Bundang Hospital
  • Korea University Anam Hospital
  • Kangbuk Samsung Hospital
  • Korea University Anam Hospital
  • Asan Medical Center
  • St Vincent Hospital of the Catholic University of Korea
  • Catholic University of Korea, Uijeongbu St. Mary's Hospital
  • Raffles Hospital
  • Oncocare Cancer Centre
  • Curie Oncology
  • Chang Gung Memorial Hospital, Kaohsiung Branch
  • Chang Gung Memorial Hospital
  • Taipei Medical University - Shuang Ho Hospital
  • Chung Shan Medical University Hospital
  • Chi Mei Hospital
  • National Cheng Kung University Hospital
  • Tri-Service General Hospital
  • National Taiwan University Hospital
  • Taipei Medical University Hospital
  • Chang Gung Memorial Hospital at Linkou

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1 (zimberelimab monotherapy)

Arm 2 (domvanalimab and zimberelimab combination therapy)

Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)

Arm Description

Participants will receive zimberelimab as an intravenous (IV) infusion.

Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.

Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion

Outcomes

Primary Outcome Measures

Objective response rate (ORR)
ORR as assessed by RECIST v1.1
Progression-free survival (PFS)
PFS as assessed by RECIST v1.1

Secondary Outcome Measures

Duration of response (DoR)
DoR as assessed by RECIST v1.1
Disease control rate (DCR)
DCR as assessed by RECIST v1.1
Overall Survival (OS)
OS as assessed at the time of PFS
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
The number and percentage of participants that experience TEAE
Pharmacokinetics of zimberelimab
Serum concentration of zimberelimab as determined by validated assays
Pharmacokinetics of domvanalimab
Serum concentration of domvanalimab as determined by validated assays
Pharmacokinetics of etrumadenant
Serum concentration of etrumadenant as determined by validated assays
Immunogenicity of zimberelimab
Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab
Immunogenicity of domvanalimab
Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab

Full Information

First Posted
January 23, 2020
Last Updated
August 8, 2023
Sponsor
Arcus Biosciences, Inc.
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04262856
Brief Title
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
Acronym
ARC-7
Official Title
A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, 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
May 28, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arcus Biosciences, Inc.
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This randomized phase 2 open-label study will evaluate the safety and efficacy of zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1 positive, metastatic non-small cell lung cancer.
Detailed Description
This is an open-label phase 2 study in participants with non-small cell lung cancer which will assess the safety, efficacy and tolerability of zimberelimab as monotherapy and in combination with other immunotherapeutics across multiple treatment arms. Approximately 150 participants will be randomized to 1 of 3 treatment arms: 1) zimberelimab, 2) zimberelimab + domvanalimab (anti-TIGIT antibody), 3) zimberelimab + domvanalimab + etrumadenant (dual adenosine receptor antagonist). Participants that progress on the zimberelimab monotherapy arm may cross-over to receive the third arm combination of zimberelimab + domvanalimab + etrumadenant. The primary objective of this clinical study is to evaluate the efficacy of each combination therapy by assessing: 1) objective response rate (ORR) of participants with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and 2) progression free survival (PFS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Nonsquamous Non Small Cell Lung Cancer, Squamous Non Small Cell Lung Cancer, Lung Cancer
Keywords
Non Small Cell Lung Cancer, Lung Cancer, NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (zimberelimab monotherapy)
Arm Type
Experimental
Arm Description
Participants will receive zimberelimab as an intravenous (IV) infusion.
Arm Title
Arm 2 (domvanalimab and zimberelimab combination therapy)
Arm Type
Experimental
Arm Description
Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.
Arm Title
Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)
Arm Type
Experimental
Arm Description
Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion
Intervention Type
Drug
Intervention Name(s)
Domvanalimab
Other Intervention Name(s)
AB154
Intervention Description
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Intervention Type
Drug
Intervention Name(s)
Etrumadenant
Other Intervention Name(s)
AB928
Intervention Description
Etrumadenant is an A2aR and A2bR antagonist
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Other Intervention Name(s)
AB122
Intervention Description
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR as assessed by RECIST v1.1
Time Frame
From randomization until death from any cause (up to approximately 3-5 years)
Title
Progression-free survival (PFS)
Description
PFS as assessed by RECIST v1.1
Time Frame
From randomization until death from any cause (up to approximately 3-5 years)
Secondary Outcome Measure Information:
Title
Duration of response (DoR)
Description
DoR as assessed by RECIST v1.1
Time Frame
From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Title
Disease control rate (DCR)
Description
DCR as assessed by RECIST v1.1
Time Frame
From the date of first occurrence of a documented objective response to first documentation of disease progression on death from any cause, whichever occurs first (up to approximately 3-5 years)
Title
Overall Survival (OS)
Description
OS as assessed at the time of PFS
Time Frame
From randomization to death from any cause (up to approximately 5 years)
Title
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Description
The number and percentage of participants that experience TEAE
Time Frame
From Screening until up to 30 days after the last dose (approximately 5 years)
Title
Pharmacokinetics of zimberelimab
Description
Serum concentration of zimberelimab as determined by validated assays
Time Frame
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
Title
Pharmacokinetics of domvanalimab
Description
Serum concentration of domvanalimab as determined by validated assays
Time Frame
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
Title
Pharmacokinetics of etrumadenant
Description
Serum concentration of etrumadenant as determined by validated assays
Time Frame
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
Title
Immunogenicity of zimberelimab
Description
Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab
Time Frame
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).
Title
Immunogenicity of domvanalimab
Description
Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab
Time Frame
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female participants; age ≥ 18 years Histologically confirmed, treatment naïve, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 Must have at least 1 measurable lesion per RECIST v1.1 Adequate organ and marrow function Exclusion Criteria: Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs) Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption) History of trauma or major surgery within 28 days prior to the first dose of IMP Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy. Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Arcus Biosciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pacific Cancer Medical Center, Inc
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Innovative Clinical Research Institute (ICRI)
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Florida Cancer Specialists
City
Englewood
State/Province
Florida
ZIP/Postal Code
34223
Country
United States
Facility Name
Florida Cancer Specialists
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Florida Cancer Specialists
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Florida Cancer Specialists - Panhandle
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Cancer Specialists - East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Baptist Hospital East
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
American Oncology Partners of Maryland, PA
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Detroit Clinical Research Center, PC
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Comprehensive Cancer Centers Of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89196
Country
United States
Facility Name
The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Clinical Research Alliance
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Northwell Health Cancer Institute
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Allegheny General Hospital (AGH)-Alleghney Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Prisma Health-Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Center For Cancer And Blood Disorders (Texas Cancer Care)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Dr.John R Waldron, MD Off of
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
Tyler Hematology-Oncology, P.A.
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Border Medical Oncology
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Coffs Harbour Health Campus
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Shoalhaven Cancer Care Centre
City
Nowra
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
Adelaide Cancer Centre
City
Elizabeth Vale
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Brampton Civic Hospital (Bch), William Osler Health Centre
City
Brampton
ZIP/Postal Code
L6R 3J7
Country
Canada
Facility Name
McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH)
City
Montréal
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
Centre Integre de Sante et de Services Sociaux des Laurentides Hopital regional de Saint-Jerome
City
Saint Jerome
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
Hong Kong United Oncology Centre
City
Hong Kong
Country
Hong Kong
Facility Name
Humanity and Health Research Center
City
Hong Kong
Country
Hong Kong
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Elizabeth Hospital (Hong Kong)
City
Hong Kong
Country
Hong Kong
Facility Name
Kosin University Gospel Hospital
City
Busan
ZIP/Postal Code
49267
Country
Korea, Republic of
Facility Name
Chonnam University Hospital
City
Hwasun
ZIP/Postal Code
58128
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
2841
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
5505
Country
Korea, Republic of
Facility Name
St Vincent Hospital of the Catholic University of Korea
City
Suwon-si
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Catholic University of Korea, Uijeongbu St. Mary's Hospital
City
Uijeongbu
ZIP/Postal Code
11765
Country
Korea, Republic of
Facility Name
Raffles Hospital
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
Facility Name
Oncocare Cancer Centre
City
Singapore
ZIP/Postal Code
258499
Country
Singapore
Facility Name
Curie Oncology
City
Singapore
ZIP/Postal Code
329563
Country
Singapore
Facility Name
Chang Gung Memorial Hospital, Kaohsiung Branch
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Taipei Medical University - Shuang Ho Hospital
City
New Taipei
ZIP/Postal Code
23561
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Chi Mei Hospital
City
Tainan City
ZIP/Postal Code
736
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital at Linkou
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. For more information, please visit our website.
IPD Sharing URL
https://trials.arcusbio.com/our-transparency-policy

Learn more about this trial

Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer

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