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

A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Zimberelimab; Drug: Domvanalimab; Drug: Quemliclustat; Drug: Platinum-Based Doublet

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arcus Biosciences; Phone Number: +1-510-462-3330; Email: ClinicalTrials@arcusbio.com

Study Locations

• Australia
  • Adelaide, Australia
    • Recruiting
    • Cancer Research SA
  • Coffs Harbour, Australia
    • Recruiting
    • Coffs Harbour Health Campus
• Korea, Republic of
  • Kwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hwasun Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Naik Gurudatta; Email: alkanand@uab.edu
      • Principal Investigator: Aparna Hegde, MD
  • Florida
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Memorial Healthcare Institute
    • Port Saint Lucie, Florida, United States, 34952
      • Recruiting
      • Hematology Oncology Associates of the Treasure Coast
    • Sarasota, Florida, United States, 34232
      • Recruiting
      • SCRI - Florida Cancer Specialists South
    • Tallahassee, Florida, United States, 32308
      • Recruiting
      • SCRI - Florida Cancer Specialists Panhandle
    • The Villages, Florida, United States, 33021
      • Recruiting
      • SCRI - Florida Cancer Specialists North
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology
  • Texas
    • Irving, Texas, United States, 75039
      • Recruiting
      • Next Oncology Dallas
  • Washington
    • Spokane, Washington, United States, 99208
      • Recruiting
      • Medical Oncology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A1: Domvanalimab + Zimberelimab; Domvanalimab and Zimberelimab, both administered by IV infusion	Drug: Zimberelimab; Administered as specified in the treatment arm; Drug: Domvanalimab; Administered as specified in the treatment arm
Experimental: A2: Domvanalimab + Zimberelimab; Domvanalimab and Zimberelimab, both administered by IV infusion	Drug: Zimberelimab; Administered as specified in the treatment arm; Drug: Domvanalimab; Administered as specified in the treatment arm
Experimental: A3: Quemliclustat + Zimberelimab; Quemliclustat and Zimberelimab, both administered by IV infusion	Drug: Zimberelimab; Administered as specified in the treatment arm; Drug: Quemliclustat; Administered as specified in the treatment arm
Experimental: B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy; Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion	Drug: Zimberelimab; Administered as specified in the treatment arm; Drug: Domvanalimab; Administered as specified in the treatment arm; Drug: Platinum-Based Doublet; Administered as specified in the treatment arm
Experimental: B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy; Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion	Drug: Zimberelimab; Administered as specified in the treatment arm; Drug: Domvanalimab; Administered as specified in the treatment arm; Drug: Quemliclustat; Administered as specified in the treatment arm; Drug: Platinum-Based Doublet; Administered as specified in the treatment arm
Experimental: C1: Quemliclustat + Zimberelimab + Docetaxel; Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion	Drug: Docetaxel; Administered as specified in the treatment arm; Drug: Zimberelimab; Administered as specified in the treatment arm; Drug: Quemliclustat; Administered as specified in the treatment arm
Experimental: C2: Domvanalimab + Zimberelimab + Docetaxel; Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion	Drug: Docetaxel; Administered as specified in the treatment arm; Drug: Domvanalimab; Administered as specified in the treatment arm; Drug: Quemliclustat; Administered as specified in the treatment arm
Experimental: B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy; Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion	Drug: Zimberelimab; Administered as specified in the treatment arm; Drug: Quemliclustat; Administered as specified in the treatment arm; Drug: Platinum-Based Doublet; Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)	Up to 58 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)	Up to 58 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	From date of first dose until the date of death due to any cause (approximately 58 months)
Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1	Up to 58 months
Disease Control Rate (DCR)	Up to 58 months
Duration of response (DoR) as determined by the Investigator according to RECIST v1.1	Up to 58 months
Investigational study treatments peak plasma or serum concentration (Cmax)	Up to 58 months
Investigational study treatments time of peak concentration (Tmax)	Up to 58 months
Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)	Up to 58 months
Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants	Up to 58 months

Collaborators and Investigators

• Sponsor: Arcus Biosciences, Inc.
• Collaborators: Gilead Sciences
• Investigators: Study Director: Medical Director, Arcus Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Anti-PD-1 antibody; Zimberelimab; Domvanalimab; Advanced Non-Small Cell Lung Cancer; Anti-TIGIT antibody; Quemliclustat
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Docetaxel; Quemliclustat
• Other Study ID Numbers: EDGE-Lung; 2022-502916-35-00 (Other Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No