Study With Various Immunotherapy Treatments in Participants With Lung Cancer

Last updated: September 29, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

Quemliclustat

Docetaxel

Platinum-Based Doublet

Clinical Study ID

NCT05676931
EDGE-Lung
2022-502916-35-00
2022-502916-35-01
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Underlying medical conditions that, in the Investigator's or Sponsor's opinion, willmake the administration of Investigational Product(s) (IPs) hazardous

  • Use of any live vaccines against infectious diseases within 28 days of first dose ofIP(s).

  • Use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone orequivalent) or immunosuppressive medications ≤ 14 days before the initiation ofstudy treatment (absorbable topical corticosteroids are not excluded).

  • Has known psychiatric or substance abuse disorders that would interfere withcooperation with the requirements of the trial.

  • Any active autoimmune disease or a documented history of autoimmune disease orsyndrome that required systemic treatment in the past 2 years (ie, with use ofdisease-modifying agents, corticosteroids, or immunosuppressive drugs), except forvitiligo or resolved childhood asthma/atopy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 400
Treatment Group(s): 5
Primary Treatment: Quemliclustat
Phase: 2
Study Start date:
February 21, 2023
Estimated Completion Date:
December 31, 2027

Study Description

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

Connect with a study center

  • The Border Cancer Hospital

    Albury, New South Wales
    Australia

    Site Not Available

  • Coffs Harbour Health Campus

    Coffs Harbour, New South Wales 2450
    Australia

    Site Not Available

  • The Border Cancer Hospital

    Albury 2178174, New South Wales 2155400
    Australia

    Site Not Available

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Site Not Available

  • Pindara Private Hospital

    Benowa 2176127, Queensland 2152274 4217
    Australia

    Site Not Available

  • Cancer Research SA Pty Ltd

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Cancer Research SA Pty Ltd

    Adelaide 2078025, South Australia 2061327 5000
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Sir Charles Gairdner Hospital

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Cancer Research SA

    Adelaide,
    Australia

    Site Not Available

  • Border Cancer Hospital

    Albury,
    Australia

    Site Not Available

  • CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque

    Bordeaux, 33604
    France

    Site Not Available

  • CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque

    Bordeaux 3031582, 33604
    France

    Site Not Available

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Lyon, 69495
    France

    Site Not Available

  • Hospices Civils de Lyon Centre Hospitalier Lyon Sud

    Lyon 2996944, 69495
    France

    Site Not Available

  • Institut De Cancerologie Strasbourg Europe ICANS

    Strasboug, 67033
    France

    Site Not Available

  • Hopital FOCH

    Suresnes,
    France

    Site Not Available

  • Hospital FOCH

    Suresnes,
    France

    Site Not Available

  • Hopital FOCH

    Suresnes 2973675,
    France

    Site Not Available

  • LTD High Technology Hospital Medcenter

    Batumi,
    Georgia

    Site Not Available

  • LTD High Technology Hospital Medcenter

    Batumi 615532,
    Georgia

    Site Not Available

  • Caucasus Medical Center

    Tbilisi,
    Georgia

    Active - Recruiting

  • Israel Georgian Medical Research Clinic Healthycore

    Tbilisi,
    Georgia

    Site Not Available

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

    Tbilisi,
    Georgia

    Active - Recruiting

  • Ltd Pineo Medical Ecosystem

    Tbilisi,
    Georgia

    Active - Recruiting

  • Caucasus Medical Center

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Israel Georgian Medical Research Clinic Healthycore

    Tbilisi 611717,
    Georgia

    Site Not Available

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

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Ltd Pineo Medical Ecosystem

    Tbilisi 611717,
    Georgia

    Site Not Available

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

    Meldola,
    Italy

    Site Not Available

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

    Meldola 3173635,
    Italy

    Site Not Available

  • stituto Nazionale per lo Studio e la Cura dei Tumori

    Milan,
    Italy

    Site Not Available

  • stituto Nazionale per lo Studio e la Cura dei Tumori

    Milan 3173435,
    Italy

    Site Not Available

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128
    Italy

    Site Not Available

  • Istituto Oncologico Veneto IRCCS

    Padua 3171728, 35128
    Italy

    Site Not Available

  • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)

    Pesaro,
    Italy

    Site Not Available

  • Azienda Sanitaria Territoriale Pesaro Urbino (AST PU)

    Pesaro 3171173,
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei tumori di Milano

    Rome,
    Italy

    Site Not Available

  • Fondazione IRCCS Istituto Nazionale dei tumori di Milano

    Rome 3169070,
    Italy

    Site Not Available

  • Samsung Changwon Hospital

    Changwon,
    Korea, Republic of

    Site Not Available

  • Samsung Changwon Hospital

    Changwon-Si,
    Korea, Republic of

    Active - Recruiting

  • Chungbuk National University Hospital

    Cheongju, 28644
    Korea, Republic of

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si,
    Korea, Republic of

    Site Not Available

  • Chonam National University Hwasun Hospital

    Hwasun-gun, 58128
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Kwangju,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Active - Recruiting

  • Szpitale Pomorskie sp. z o.o

    Gdynia,
    Poland

    Site Not Available

  • Szpitale Pomorskie sp. z o.o

    Gdynia 3099424,
    Poland

    Site Not Available

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

    Katowice,
    Poland

    Site Not Available

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

    Katowice 3096472,
    Poland

    Site Not Available

  • Medpolonia Sp. Z.o.o.

    Poznan,
    Poland

    Site Not Available

  • Medpolonia Sp. Z.o.o.

    Poznan 3088171,
    Poland

    Site Not Available

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

    Warsaw,
    Poland

    Site Not Available

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

    Warsaw 756135,
    Poland

    Site Not Available

  • Samsung Changwon Hospital

    Changwon-Si,
    South Korea

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si 1845604, 28644
    South Korea

    Site Not Available

  • Chonam National University Hwasun Hospital

    Hwasun-gun, 58128
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul 1835848, 138-736
    South Korea

    Site Not Available

  • Korea University Guro Hospital

    Seoul 1835848, 08308
    South Korea

    Site Not Available

  • Hospital Universitari Mutua Terrassa

    Barcelona, 8221
    Spain

    Site Not Available

  • Hospital Universitario MútuaTerrassa (HUMT)

    Barcelona,
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041
    Spain

    Site Not Available

  • UOMI Cancer Centre

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitari Mutua Terrassa

    Barcelona 3128760, 8221
    Spain

    Site Not Available

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, 8041
    Spain

    Site Not Available

  • UOMI Cancer Centre

    Barcelona 3128760,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario Insular Materno Infantil De Gran Canaria

    Las Palmas De Gran Canaria, 35016
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    Las Palmas De Gran Canaria, 35016
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario Insular Materno Infantil De Gran Canaria

    Las Palmas de Gran Canaria 2515270, 35016
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo,
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti

    Lugo 3117814,
    Spain

    Site Not Available

  • Hospital Quirónsalud Málaga

    Malaga,
    Spain

    Site Not Available

  • Hospital Quirónsalud Málaga

    Málaga 2514256,
    Spain

    Site Not Available

  • Hospital Universitario De La Virgen De Valme

    Sevilla, 41001
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Hospital Virgen Macarena / HUVM

    Sevilla,
    Spain

    Site Not Available

  • Hospital Universitario De La Virgen De Valme

    Seville 2510911, 41001
    Spain

    Site Not Available

  • Hospital Universitario Virgen Macarena

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Hospital 9 de Octubre Vithas Valencia

    Valencia, 46015
    Spain

    Site Not Available

  • Hospital Universitario y Politécnico la Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Vithas Valencia 9 de Octubre

    Valencia, 46015
    Spain

    Active - Recruiting

  • Hospital 9 de Octubre Vithas Valencia

    Valencia 2509954, 46015
    Spain

    Site Not Available

  • Hospital Universitario y Politécnico la Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Hualien Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

    Hualien, 970
    Taiwan

    Site Not Available

  • Hualien Tzu Chi Hospital

    Hualien City,
    Taiwan

    Site Not Available

  • E-Da Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • E-DA Healthcare Group E-DA Hospital

    Kaoshiung, 970
    Taiwan

    Site Not Available

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

    New Taipei, 23561
    Taiwan

    Site Not Available

  • Taipai Medical University - Shuang Ho Hospital

    New Taipei City,
    Taiwan

    Site Not Available

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

    New Taipei City 12908892, 23561
    Taiwan

    Site Not Available

  • Mackay Memorial Hospital Taipei

    Taipei,
    Taiwan

    Site Not Available

  • Mackey Memorial Hospital

    Taipei, 104
    Taiwan

    Site Not Available

  • Mackey Memorial Hospital

    Taipei 1668341, 104
    Taiwan

    Site Not Available

  • National Taiwan University Hospital Yumlin Branch

    Yunlin County,
    Taiwan

    Site Not Available

  • Barts Health NHS Trust St Bartholomew's Hospital

    London, W1G 6AF
    United Kingdom

    Site Not Available

  • St. Bartholomew's Hospital

    London,
    United Kingdom

    Site Not Available

  • Barts Health NHS Trust St Bartholomew's Hospital

    London 2643743, W1G 6AF
    United Kingdom

    Site Not Available

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Alabama at Birmingham (UAB)

    Birmingham 4049979, Alabama 4829764 35294
    United States

    Site Not Available

  • University of California San Diego (UCSD)

    La Jolla, California 92093
    United States

    Site Not Available

  • University of California San Diego (UCSD)

    La Jolla 5363943, California 5332921 92093
    United States

    Site Not Available

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Memorial Healthcare Institute

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Hematology Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida 34952
    United States

    Site Not Available

  • Florida Cancer Specialists (Administration and Drug Shipment)

    Sarasota, Florida 34232
    United States

    Site Not Available

  • SCRI - Florida Cancer Specialists South

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Florida Cancer Specialists

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • SCRI - Florida Cancer Specialists Panhandle

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Florida Cancer Specialists (Administration and Drug Shipment)

    The Villages, Florida 32163
    United States

    Site Not Available

  • SCRI - Florida Cancer Specialists North

    The Villages, Florida 33021
    United States

    Site Not Available

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood 4158928, Florida 4155751 33021
    United States

    Site Not Available

  • Hematology Oncology Associates Of The Treasure Coast

    Port Saint Lucie 4169171, Florida 4155751 34952
    United States

    Site Not Available

  • Florida Cancer Specialists (Administration and Drug Shipment)

    The Villages 4175179, Florida 4155751 32163
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60208
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    Jefferson, Louisiana 70121
    United States

    Site Not Available

  • Ochsner Clinic Foundation

    Jefferson 4328973, Louisiana 4331987 70121
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Kettering Health Cancer Center

    Kettering, Ohio 45429
    United States

    Site Not Available

  • Kettering Medical Center

    Kettering, Ohio 45429
    United States

    Site Not Available

  • SCRI - Tennessee Oncology - Chattanooga - Memorial Plaza

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Next Oncology Dallas

    Irving, Texas 75039
    United States

    Site Not Available

  • Virginia Cancer Specialists

    Fairfax, Virginia 08613
    United States

    Site Not Available

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Site Not Available

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

    Spokane, Washington 99208
    United States

    Site Not Available

  • Medical Oncology Associates

    Spokane, Washington 99208
    United States

    Site Not Available

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

    Spokane 5811696, Washington 5815135 99208
    United States

    Site Not Available

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