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Advanced Non-Small Cell Lung CancerPhase 2EDGE-LungNCT05676931

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

A Phase 2 study testing Domvanalimab, Quemliclustat and Zimberelimab in people with Advanced Non-Small Cell Lung Cancer, run by Gilead Sciences at 53 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Non-Small Cell Lung Cancer
What is being tested?
Domvanalimab, Quemliclustat and Zimberelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
53 sitesin 10 countries
Study dates
21 Feb 2023to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

53 sites in 10 countries.

53 sites in 10 countries

United States10 sites

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35294

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia, 22031

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Ochsner Clinic Foundation

    Jefferson, Louisiana, 70121

  • University of California San Diego (UCSD)

    La Jolla, California, 92093

  • Hematology Oncology Associates Of The Treasure Coast

    Port Saint Lucie, Florida, 34952

  • Medical Oncology Associated, PS (dba Summit Cancer Centers)

    Spokane, Washington, 99208

  • Florida Cancer Specialists (Administration and Drug Shipment)

    The Villages, Florida, 32163

Other trials in United States

Spain10 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitari Mutua Terrassa

    Barcelona, 8221

  • UOMI Cancer Centre

    Barcelona

  • Complejo Hospitalario Universitario Insular Materno Infantil De Gran Canaria

    Las Palmas de Gran Canaria, 35016

  • Hospital Universitario Lucus Augusti

    Lugo

  • Hospital Quirónsalud Málaga

    Málaga

  • Hospital Universitario De La Virgen De Valme

    Seville, 41001

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital 9 de Octubre Vithas Valencia

    Valencia, 46015

  • Hospital Universitario y Politécnico la Fe

    Valencia, 46026

Other trials in Spain

Georgia5 sites

  • LTD High Technology Hospital Medcenter

    Batumi

  • Caucasus Medical Center

    Tbilisi

  • Israel Georgian Medical Research Clinic Healthycore

    Tbilisi

  • JSC K. Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi

  • Ltd Pineo Medical Ecosystem

    Tbilisi

Other trials in Georgia

Italy5 sites

  • Istituto Romagnolo per lo Studio dei Tumori-Dino Amadori - IRST

    Meldola

  • stituto Nazionale per lo Studio e la Cura dei Tumori

    Milan

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)

    Pesaro

  • Fondazione IRCCS Istituto Nazionale dei tumori di Milano

    Rome

Other trials in Italy

South Korea5 sites

  • Samsung Changwon Hospital

    Changwon-Si

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Chonam National University Hwasun Hospital

    Hwasun-gun, 58128

  • Korea University Guro Hospital

    Seoul, 08308

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Taiwan5 sites

  • Hualien Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

    Hualien City, 970

  • E-DA Healthcare Group E-DA Hospital

    Kaoshiung, 970

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, 23561

  • Mackey Memorial Hospital

    Taipei, 104

  • National Taiwan University Hospital Yumlin Branch

    Yunlin County

Other trials in Taiwan

Australia4 sites

  • Cancer Research SA Pty Ltd

    Adelaide, South Australia, 5000

  • The Border Cancer Hospital

    Albury, New South Wales

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

Other trials in Australia

France4 sites

  • CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque

    Bordeaux, 33604

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Lyon, 69495

  • Institut De Cancerologie Strasbourg Europe ICANS

    Strasboug, 67033

  • Hopital FOCH

    Suresnes

Other trials in France

Poland4 sites

  • Szpitale Pomorskie sp. z o.o

    Gdynia

  • Uniwersyteckie Centrum Kliniczne, im. prof. K. Gibińskiego

    Katowice

  • Medpolonia Sp. Z.o.o.

    Poznan

  • Centrum Onkologii - Instytut im. Marii Sk?odowskiej-Curie

    Warsaw

Other trials in Poland

United Kingdom1 site

  • Barts Health NHS Trust St Bartholomew's Hospital

    London, W1G 6AF

Other trials in United Kingdom

About this study

Official title: 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.

Read the detailed description

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

Being tested
Domvanalimab, Quemliclustat, Zimberelimab, Docetaxel, Platinum-Based Doublet
Keywords
Advanced Non-Small Cell Lung Cancer, Domvanalimab, Zimberelimab, Quemliclustat, Anti-TIGIT antibody, Anti-PD-1 antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DomvanalimabDrug

    Administered as specified in the treatment arm

  • QuemliclustatDrug

    Administered as specified in the treatment arm

  • ZimberelimabDrug

    Administered as specified in the treatment arm

  • DocetaxelDrug

    Administered as specified in the treatment arm

  • Platinum-Based DoubletDrug

    Administered as specified in the treatment arm

Study groups in NCT05676931
Study groupRoleWhat they receive
A1: Domvanalimab + ZimberelimabExperimentalDomvanalimab and Zimberelimab, both administered by IV infusion
Receives: Drug: Domvanalimab; Drug: Zimberelimab
A2: Domvanalimab + ZimberelimabExperimentalDomvanalimab and Zimberelimab, both administered by IV infusion
Receives: Drug: Domvanalimab; Drug: Zimberelimab
A3: Quemliclustat + ZimberelimabExperimentalQuemliclustat and Zimberelimab, both administered by IV infusion
Receives: Drug: Quemliclustat; Drug: Zimberelimab
B1: Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyExperimentalQuemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Receives: Drug: Quemliclustat; Drug: Zimberelimab; Drug: Platinum-Based Doublet
B2: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyExperimentalDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Receives: Drug: Domvanalimab; Drug: Zimberelimab; Drug: Platinum-Based Doublet
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyExperimentalDomvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Receives: Drug: Domvanalimab; Drug: Quemliclustat; Drug: Zimberelimab; Drug: Platinum-Based Doublet
B4: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyExperimentalDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Receives: Drug: Domvanalimab; Drug: Zimberelimab; Drug: Platinum-Based Doublet
B5: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyExperimentalDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
Receives: Drug: Domvanalimab; Drug: Zimberelimab; Drug: Platinum-Based Doublet
C1: Quemliclustat + Zimberelimab + DocetaxelExperimentalQuemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
Receives: Drug: Quemliclustat; Drug: Zimberelimab; Drug: Docetaxel
C2: Domvanalimab + Zimberelimab + DocetaxelExperimentalDomvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
Receives: Drug: Domvanalimab; Drug: Zimberelimab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 58 months

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

    Measured: Up to 58 months

Secondary outcomes (8)

  1. Overall Survival (OS)

    Measured: 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

    Measured: Up to 58 months

  3. Disease Control Rate (DCR)

    Measured: Up to 58 months

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

    Measured: Up to 58 months

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

    Measured: Up to 58 months

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

    Measured: Up to 58 months

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

    Measured: Up to 58 months

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

    Measured: Up to 58 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start21 Feb 2023
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05676931
Sponsor's protocol ID
EDGE-Lung
Other IDs
2022-502916-35-01
Acronym
EDGE-Lung
Status last verified
May 2026
First submitted
9 Dec 2022
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Domvanalimab, Quemliclustat and Zimberelimab in people with Advanced Non-Small Cell Lung Cancer, run by Gilead Sciences at 53 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Spain, Georgia, Italy, South Korea and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (time frame: Up to 58 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05676931.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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