CClinicalTrials.gg
Active, not recruitingNCT05676931EDGE-LungUpdated Jun 1, 2026

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

A Phase 2 interventional study of Domvanalimab and Quemliclustat in Advanced Non-Small Cell Lung Cancer, sponsored by Gilead Sciences. Active, not recruiting at 53 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Advanced Non-Small Cell Lung Cancer

Keywords

  • Advanced Non-Small Cell Lung Cancer
  • Domvanalimab
  • Zimberelimab
  • Quemliclustat
  • Anti-TIGIT antibody
  • Anti-PD-1 antibody
03

In context

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    A1: Domvanalimab + Zimberelimab

    Domvanalimab and Zimberelimab, both administered by IV infusion

    Drug: Domvanalimab · Drug: Zimberelimab

  • Experimental
    A2: Domvanalimab + Zimberelimab

    Domvanalimab and Zimberelimab, both administered by IV infusion

    Drug: Domvanalimab · Drug: Zimberelimab

  • Experimental
    A3: Quemliclustat + Zimberelimab

    Quemliclustat and Zimberelimab, both administered by IV infusion

    Drug: Quemliclustat · Drug: Zimberelimab

  • Experimental
    B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy

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

    Drug: Quemliclustat · Drug: Zimberelimab · Drug: Platinum-Based Doublet

  • Experimental
    B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy

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

    Drug: Domvanalimab · Drug: Zimberelimab · Drug: Platinum-Based Doublet

  • Experimental
    B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy

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

    Drug: Domvanalimab · Drug: Quemliclustat · Drug: Zimberelimab · Drug: Platinum-Based Doublet

  • Experimental
    B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy

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

    Drug: Domvanalimab · Drug: Zimberelimab · Drug: Platinum-Based Doublet

  • Experimental
    B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy

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

    Drug: Domvanalimab · Drug: Zimberelimab · Drug: Platinum-Based Doublet

  • Experimental
    C1: Quemliclustat + Zimberelimab + Docetaxel

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

    Drug: Quemliclustat · Drug: Zimberelimab · Drug: Docetaxel

  • Experimental
    C2: Domvanalimab + Zimberelimab + Docetaxel

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

    Drug: Domvanalimab · Drug: Zimberelimab · Drug: Docetaxel

Interventions

  • DrugDomvanalimab

    Administered as specified in the treatment arm

  • DrugQuemliclustat

    Administered as specified in the treatment arm

  • DrugZimberelimab

    Administered as specified in the treatment arm

  • DrugDocetaxel

    Administered as specified in the treatment arm

  • DrugPlatinum-Based Doublet

    Administered as specified in the treatment arm

06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Time frame: Up to 58 months

  2. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Up to 58 months

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From date of first dose until the date of death due to any cause (approximately 58 months)

  2. Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 58 months

  3. Disease Control Rate (DCR)

    Time frame: Up to 58 months

  4. Duration of response (DoR) as determined by the Investigator according to RECIST v1.1

    Time frame: Up to 58 months

  5. Investigational study treatments peak plasma or serum concentration (Cmax)

    Time frame: Up to 58 months

  6. Investigational study treatments time of peak concentration (Tmax)

    Time frame: Up to 58 months

  7. Investigational study treatments area under the plasma or serum concentration versus time curve (AUC)

    Time frame: Up to 58 months

  8. Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants

    Time frame: Up to 58 months

07

Study locations

53 sites
  • University of Alabama at Birmingham (UAB)
    Birmingham, Alabama 35294, United States
  • University of California San Diego (UCSD)
    La Jolla, California 92093, United States
  • Memorial Cancer Institute at Memorial Regional Hospital
    Hollywood, Florida 33021, United States
  • Hematology Oncology Associates Of The Treasure Coast
    Port Saint Lucie, Florida 34952, United States
  • Florida Cancer Specialists (Administration and Drug Shipment)
    The Villages, Florida 32163, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • Ochsner Clinic Foundation
    Jefferson, Louisiana 70121, United States
  • Henry Ford Hospital
    Detroit, Michigan 48202, United States
  • Virginia Cancer Specialists, PC
    Fairfax, Virginia 22031, United States
  • Medical Oncology Associated, PS (dba Summit Cancer Centers)
    Spokane, Washington 99208, United States
  • The Border Cancer Hospital
    Albury, New South Wales, Australia
  • Pindara Private Hospital
    Benowa, Queensland 4217, Australia
  • Cancer Research SA Pty Ltd
    Adelaide, South Australia 5000, Australia
  • Sir Charles Gairdner Hospital
    Nedlands, Western Australia 6009, Australia
  • CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque
    Bordeaux, 33604, France
  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
    Lyon, 69495, France
  • Institut De Cancerologie Strasbourg Europe ICANS
    Strasboug, 67033, France
  • Hopital FOCH
    Suresnes, France
  • LTD High Technology Hospital Medcenter
    Batumi, Georgia
  • Caucasus Medical Center
    Tbilisi, Georgia
  • Israel Georgian Medical Research Clinic Healthycore
    Tbilisi, Georgia
  • JSC K. Eristavi National Center of Experimental and Clinical Surgery
    Tbilisi, Georgia
  • Ltd Pineo Medical Ecosystem
    Tbilisi, Georgia
  • Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST
    Meldola, Italy
  • stituto Nazionale per lo Studio e la Cura dei Tumori
    Milan, Italy
  • Istituto Oncologico Veneto IRCCS
    Padova, 35128, Italy
  • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)
    Pesaro, Italy
  • Fondazione IRCCS Istituto Nazionale dei tumori di Milano
    Rome, Italy
  • Szpitale Pomorskie sp. z o.o
    Gdynia, Poland
  • Uniwersyteckie Centrum Kliniczne, im. prof. K. Gibińskiego
    Katowice, Poland
  • Medpolonia Sp. Z.o.o.
    Poznan, Poland
  • Centrum Onkologii - Instytut im. Marii Sk?odowskiej-Curie
    Warsaw, Poland
  • Samsung Changwon Hospital
    Changwon-Si, South Korea
  • Chungbuk National University Hospital
    Cheongju-si, 28644, South Korea
  • Chonam National University Hwasun Hospital
    Hwasun-gun, 58128, South Korea
  • Korea University Guro Hospital
    Seoul, 08308, South Korea
  • Asan Medical Center
    Seoul, 138-736, South Korea
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, 8041, Spain
  • Hospital Universitari Mutua Terrassa
    Barcelona, 8221, Spain
  • UOMI Cancer Centre
    Barcelona, Spain
  • Complejo Hospitalario Universitario Insular Materno Infantil De Gran Canaria
    Las Palmas de Gran Canaria, 35016, Spain
  • Hospital Universitario Lucus Augusti
    Lugo, Spain
  • Hospital Quirónsalud Málaga
    Málaga, Spain
  • Hospital Universitario De La Virgen De Valme
    Seville, 41001, Spain
  • Hospital Universitario Virgen Macarena
    Seville, 41009, Spain
  • Hospital 9 de Octubre Vithas Valencia
    Valencia, 46015, Spain
  • Hospital Universitario y Politécnico la Fe
    Valencia, 46026, Spain
  • Hualien Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation
    Hualien City, 970, Taiwan
  • E-DA Healthcare Group E-DA Hospital
    Kaoshiung, 970, Taiwan
  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
    New Taipei City, 23561, Taiwan
  • Mackey Memorial Hospital
    Taipei, 104, Taiwan
  • National Taiwan University Hospital Yumlin Branch
    Yunlin County, Taiwan
  • Barts Health NHS Trust St Bartholomew's Hospital
    London, W1G 6AF, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05676931
Lead sponsor
Gilead Sciences
Collaborators
Arcus Biosciences, Inc.
Responsible party
Sponsor
First posted
Jan 9, 2023
Start date
Feb 21, 2023
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 1, 2026

Study contacts

Gilead Study Director
study director · Gilead Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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