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Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer (EDGE-Lung)

Primary Purpose

Advanced Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Domvanalimab
Quemliclustat
Zimberelimab
Docetaxel
Platinum-Based Doublet
Sponsored by
Arcus Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-Small Cell Lung Cancer focused on measuring Advanced Non-Small Cell Lung Cancer, Domvanalimab, Zimberelimab, Quemliclustat, Anti-TIGIT antibody, Anti-PD-1 antibody

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed, documented diagnosis of Stage IV metastatic, NSCLC Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 At least one measurable target lesion per RECIST v1.1. Adequate organ and marrow function Participants must be willing to provide adequate tumor tissue Exclusion Criteria: Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s). Concurrent chronic medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded). Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 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 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • SCRI - Tennessee Oncology - Chattanooga - Memorial PlazaRecruiting
  • Medical Oncology AssociatesRecruiting
  • Cancer Research SARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

A1: Domvanalimab + Zimberelimab

A2: Domvanalimab + Zimberelimab

A3: Quemliclustat + Zimberelimab

B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy

B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy

B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy

C1: Quemliclustat + Zimberelimab + Docetaxel

C2: Domvanalimab + Zimberelimab + Docetaxel

Arm Description

Domvanalimab and Zimberelimab, both administered by IV infusion

Domvanalimab and Zimberelimab, both administered by IV infusion

Quemliclustat and Zimberelimab, both administered by IV infusion

Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion

Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion

Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion

Outcomes

Primary Outcome Measures

Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Secondary Outcome Measures

Overall Survival (OS)
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Disease Control Rate (DCR)
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Investigational study treatments peak plasma or serum concentration (Cmax)
Investigational study treatments time of peak concentration (Tmax)
Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)
Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants

Full Information

First Posted
December 9, 2022
Last Updated
August 30, 2023
Sponsor
Arcus Biosciences, Inc.
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05676931
Brief Title
Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer
Acronym
EDGE-Lung
Official Title
A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Non-Small Cell Lung Cancer
Keywords
Advanced Non-Small Cell Lung Cancer, Domvanalimab, Zimberelimab, Quemliclustat, Anti-TIGIT antibody, Anti-PD-1 antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A1: Domvanalimab + Zimberelimab
Arm Type
Experimental
Arm Description
Domvanalimab and Zimberelimab, both administered by IV infusion
Arm Title
A2: Domvanalimab + Zimberelimab
Arm Type
Experimental
Arm Description
Domvanalimab and Zimberelimab, both administered by IV infusion
Arm Title
A3: Quemliclustat + Zimberelimab
Arm Type
Experimental
Arm Description
Quemliclustat and Zimberelimab, both administered by IV infusion
Arm Title
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Arm Type
Experimental
Arm Description
Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Arm Title
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
Arm Type
Experimental
Arm Description
Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Arm Title
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
Arm Type
Experimental
Arm Description
Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Arm Title
C1: Quemliclustat + Zimberelimab + Docetaxel
Arm Type
Experimental
Arm Description
Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
Arm Title
C2: Domvanalimab + Zimberelimab + Docetaxel
Arm Type
Experimental
Arm Description
Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
Intervention Type
Drug
Intervention Name(s)
Domvanalimab
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Quemliclustat
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Zimberelimab
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Administered as specified in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Platinum-Based Doublet
Intervention Description
Administered as specified in the treatment arm
Primary Outcome Measure Information:
Title
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Time Frame
Up to 58 months
Title
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Up to 58 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
From date of first dose until the date of death due to any cause (approximately 58 months)
Title
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Time Frame
Up to 58 months
Title
Disease Control Rate (DCR)
Time Frame
Up to 58 months
Title
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1
Time Frame
Up to 58 months
Title
Investigational study treatments peak plasma or serum concentration (Cmax)
Time Frame
Up to 58 months
Title
Investigational study treatments time of peak concentration (Tmax)
Time Frame
Up to 58 months
Title
Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)
Time Frame
Up to 58 months
Title
Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants
Time Frame
Up to 58 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed, documented diagnosis of Stage IV metastatic, NSCLC Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 At least one measurable target lesion per RECIST v1.1. Adequate organ and marrow function Participants must be willing to provide adequate tumor tissue Exclusion Criteria: Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s). Concurrent chronic medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded). Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 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 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arcus Biosciences
Phone
+1-510-462-3330
Email
ClinicalTrials@arcusbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Arcus Biosciences
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naik Gurudatta
Email
alkanand@uab.edu
First Name & Middle Initial & Last Name & Degree
Aparna Hegde, MD
Facility Name
SCRI - Tennessee Oncology - Chattanooga - Memorial Plaza
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Oncology Associates
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Research SA
City
Adelaide
Country
Australia
Individual Site Status
Recruiting

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 With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer

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