Study With Various Immunotherapy Treatments in Participants With 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: Active, not recruiting
• Conditions: Advanced Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Zimberelimab; Drug: Domvanalimab; Drug: Quemliclustat; Drug: Platinum-Based Doublet

Detailed Description

The study includes multiple substudy arms (Substudy A, B, C), which will evaluate immunotherapy-based combinations.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Albury, New South Wales, Australia
      • The Border Cancer Hospital
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • Pindara Private Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Cancer Research SA Pty Ltd
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• France
  • Bordeaux, France, 33604
    • CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque
  • Lyon, France, 69495
    • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Strasboug, France, 67033
    • Institut de Cancerologie Strasbourg Europe ICANS
  • Suresnes, France
    • Hopital Foch
• Georgia
  • Batumi, Georgia
    • LTD High Technology Hospital Medcenter
  • Tbilisi, Georgia
    • JSC K. Eristavi National Center of Experimental and Clinical Surgery
  • Tbilisi, Georgia
    • Caucasus Medical Center
  • Tbilisi, Georgia
    • Israel Georgian Medical Research Clinic Healthycore
  • Tbilisi, Georgia
    • LTD Pineo Medical Ecosystem
• Italy
  • Meldola, Italy
    • Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
  • Milan, Italy
    • stituto Nazionale per lo Studio e la Cura dei Tumori
  • Padova, Italy, 35128
    • Istituto Oncologico Veneto IRCCS
  • Pesaro, Italy
    • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
  • Rome, Italy
    • Fondazione IRCCS Istituto Nazionale dei tumori di Milano
• Poland
  • Gdynia, Poland
    • Szpitale Pomorskie sp. z o.o
  • Katowice, Poland
    • Uniwersyteckie Centrum Kliniczne, im. prof. K. Gibińskiego
  • Poznan, Poland
    • Medpolonia Sp. Z.o.o.
  • Warsaw, Poland
    • Centrum Onkologii - Instytut im. Marii Sk?odowskiej-Curie
• South Korea
  • Changwon-Si, South Korea
    • Samsung Changwon Hospital
  • Cheongju-si, South Korea, 28644
    • Chungbuk National University Hospital
  • Hwasun-gun, South Korea, 58128
    • Chonam National University Hwasun Hospital
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 138-736
    • Asan Medical Center
• Spain
  • Barcelona, Spain, 8041
    • Hospital De La Santa Creu I Sant Pau
  • Barcelona, Spain, 8221
    • Hospital Universitari Mutua Terrassa
  • Barcelona, Spain
    • UOMI Cancer Centre
  • Las Palmas de Gran Canaria, Spain, 35016
    • Complejo Hospitalario Universitario Insular Materno Infantil De Gran Canaria
  • Lugo, Spain
    • Hospital Universitario Lucus Augusti
  • Málaga, Spain
    • Hospital Quironsalud Malaga
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Seville, Spain, 41001
    • Hospital Universitario De La Virgen De Valme
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La Fe
  • Valencia, Spain, 46015
    • Hospital 9 de Octubre Vithas Valencia
• Taiwan
  • Hualien City, Taiwan, 970
    • Hualien Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation
  • Kaoshiung, Taiwan, 970
    • E-DA Healthcare Group E-DA Hospital
  • New Taipei City, Taiwan, 23561
    • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
  • Taipei, Taiwan, 104
    • Mackey Memorial Hospital
  • Yunlin County, Taiwan
    • National Taiwan University Hospital Yumlin Branch
• United Kingdom
  • London, United Kingdom, W1G 6AF
    • Barts Health NHS Trust St Bartholomew's Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham (UAB)
  • California
    • La Jolla, California, United States, 92093
      • University of California San Diego (UCSD)
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute at Memorial Regional Hospital
    • Port Saint Lucie, Florida, United States, 34952
      • Hematology Oncology Associates of the Treasure Coast
    • The Villages, Florida, United States, 32163
      • Florida Cancer Specialists (Administration and Drug Shipment)
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Louisiana
    • Jefferson, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists, PC
  • Washington
    • Spokane, Washington, United States, 99208
      • Medical Oncology Associated, PS (dba Summit Cancer Centers)

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Histologically or cytologically documented 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 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).
• Use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications ≤ 14 days before the initiation of study treatment (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

10

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: Zimberelimab; Administered as specified in the treatment arm; Drug: Domvanalimab; 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
Experimental: B4: 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: B5: 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

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

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

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): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

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: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; zimberelimab; quemliclustat
• Other Study ID Numbers: EDGE-Lung; 2022-502916-35-01 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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