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
2 other identifiers
interventional
400
10 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2023
Longer than P75 for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
January 9, 2023
CompletedStudy Start
First participant enrolled
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
October 2, 2025
September 1, 2025
4.8 years
December 9, 2022
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (10)
A1: Domvanalimab + Zimberelimab
EXPERIMENTALDomvanalimab and Zimberelimab, both administered by IV infusion
A2: Domvanalimab + Zimberelimab
EXPERIMENTALDomvanalimab and Zimberelimab, both administered by IV infusion
A3: Quemliclustat + Zimberelimab
EXPERIMENTALQuemliclustat and Zimberelimab, both administered by IV infusion
B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
EXPERIMENTALQuemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
EXPERIMENTALDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy
EXPERIMENTALDomvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
EXPERIMENTALDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy
EXPERIMENTALDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
C1: Quemliclustat + Zimberelimab + Docetaxel
EXPERIMENTALQuemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
C2: Domvanalimab + Zimberelimab + Docetaxel
EXPERIMENTALDomvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion
Interventions
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Administered as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Arcus Biosciences, Inc.collaborator
Study Sites (51)
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
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
Padua, 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
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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2022
First Posted
January 9, 2023
Study Start
February 21, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share