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NCT05676931 | RECRUITING | Advanced Non-Small Cell Lung Cancer

Study With Various Immunotherapy Treatments in Participants With Lung Cancer
Sponsor:

Gilead Sciences

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.

Condition or disease

Advanced Non-Small Cell Lung Cancer

Intervention/treatment

Domvanalimab

Quemliclustat

Zimberelimab

Docetaxel

Platinum-Based Doublet

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase II, Open-label, Platform Study, to Evaluate Immunotherapy-based Combinations in Participants With Advanced Non-Small Cell Lung Cancer
Actual Study Start Date : 2023-02-21
Estimated Primary Completion Date : 2027-12
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 With Various Immunotherapy Treatments in Participants With Lung Cancer

Location Details

NCT05676931

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham (UAB)

Birmingham, Albama, United States, 35294

RECRUITING

United States, California

University of California San Diego (UCSD)

THE JOLLA, California, United States, 92093

RECRUITING

United States, Florida

Memorial Cancer Institute at Memorial Regional Hospital

Hollywood, Florida, United States, 33021

RECRUITING

United States, Florida

Hematology Oncology Associates Of The Treasure Coast

Port Saint Lucie, Florida, United States, 34952

WITHDRAWN

United States, Florida

Florida Cancer Specialists (Administration and Drug Shipment)

Sarasota, Florida, United States, 34232

WITHDRAWN

United States, Florida

Florida Cancer Specialists

Tallahassee, Florida, United States, 32308

RECRUITING

United States, Florida

Florida Cancer Specialists (Administration and Drug Shipment)

The Villages, Florida, United States, 32163

RECRUITING

United States, Illinois

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

RECRUITING

United States, Louisiana

Ochsner Clinic Foundation

Jefferson, Louisiana, United States, 70121

RECRUITING

United States, Road cancer

Henry Ford Hospital

Detroit, Road cancer, United States, 48202

WITHDRAWN

United States, Ohio

Kettering Health Cancer Center

Kettering, Ohio, United States, 45429

WITHDRAWN

United States, Tennessee

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Virginia

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States, 22031

RECRUITING

United States, Washington

Medical Oncology Associated, PS (dba Summit Cancer Centers)

Spocane, Washington, United States, 99208

RECRUITING

Australia, New South Wales

The Border Cancer Hospital

Albury, New South Wales, Australia,

WITHDRAWN

Australia, New South Wales

Coffs Harbour Health Campus

Coffs Harbour, New South Wales, Australia, 2450

RECRUITING

Australia, Queensland

Pindara Private Hospital

Benowa, Queensland, Australia, 4217

RECRUITING

Australia, South Australia

Cancer Research SA Pty Ltd

Adelaide, South Australia, Australia, 5000

RECRUITING

Australia, Western Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia, 6009

RECRUITING

France,

CHU Bordeaux Center Francois Magendie High Lévèque Hospital Hospital

Bordeaux, France, 33604

RECRUITING

France,

Lyon South Lyon Hospital Hospices in Lyon Center

Lyon, France, 69495

RECRUITING

France,

Strasbourg Europe Icans Cancerology Institute

Strasboug, France, 67033

RECRUITING

France,

Foch hospital

Suresnes, France,

RECRUITING

Georgia,

LTD High Technology Hospital Medcenter

Batumi, Georgia,

RECRUITING

Georgia,

Caucasus Medical Center

Tbilisi, Georgia,

RECRUITING

Georgia,

Israel Georgian Medical Research Clinic Healthycore

Tbilisi, Georgia,

RECRUITING

Georgia,

JSC K. Eristavi National Center of Experimental and Clinical Surgery

Tbilisi, Georgia,

RECRUITING

Georgia,

Ltd Pineo Medical Ecosystem

Tbilisi, Georgia,

RECRUITING

Italy,

Romagna Institute for the study of tumors -ino Amadori - Irst

Meldola, Italy,

NOT YET RECRUITING

Italy,

National Institute for the Study and Care of Tumors

Milan, Italy,

RECRUITING

Italy,

Veneto IRCCS Oncological Institute

Padova, Italy, 35128

RECRUITING

Italy,

Pesaro Urbino Territorial Health Authority (AST PU)

Pesaro, Italy,

RECRUITING

Italy,

IRCCS Foundation National Cancer Institute of Milan

Rome, Italy,

RECRUITING

Korea, Republic of,

Samsung Changwon Hospital

Changwon-Si, Korea, Republic of,

RECRUITING

Korea, Republic of,

Chungbuk National University Hospital

Cheongju, Korea, Republic of, 28644

RECRUITING

Korea, Republic of,

Chonam National University Hwasun Hospital

Hwasun-gun, Korea, Republic of, 58128

RECRUITING

Korea, Republic of,

Korea University Teacher Hospital

Seoul, Korea, Republic of, 08308

RECRUITING

Korea, Republic of,

Asan Medical Center

Seoul, Korea, Republic of, 138-736

RECRUITING

Poland,

Hospitals Pomorskie sp.z o.o

Gdynia, Poland,

RECRUITING

Poland,

University Clinical Center, prof. K. Gibiński

Katowice, Poland,

RECRUITING

Poland,

Medpolonia Sp. Z.o.o.

Poznan, Poland,

RECRUITING

Poland,

Oncology Center - Institute Maria Skłodowska-Curie

Warsaw, Poland,

RECRUITING

Spain,

Hospital of the Holy Cross and Sant Pau

Barcelona, Spain, 8041

RECRUITING

Spain,

Mutua Terrassa University Hospital

Barcelona, Spain, 8221

RECRUITING

Spain,

Uomi Cancer Center

Barcelona, Spain,

RECRUITING

Spain,

Maternal Children's Insular University Hospital Complex of Gran Canaria

Las Palmas de Gran Canaria, Spain, 35016

RECRUITING

Spain,

Lucus Augusti University Hospital

Lugo, Spain,

RECRUITING

Spain,

Quirónsalud Malaga Hospital

Malaga, Spain,

RECRUITING

Spain,

University Hospital of the Virgen de Valme

Sevilla, Spain, 41001

RECRUITING

Spain,

Virgen Macarena University Hospital

Sevilla, Spain, 41009

RECRUITING

Spain,

October 9 Hospital Vithas Valencia

Valencia, Spain, 46015

RECRUITING

Spain,

La Fe University and Polytechnic Hospital

Valencia, Spain, 46026

RECRUITING

Taiwan,

Hualien Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

hu alien, Taiwan, 970

RECRUITING

Taiwan,

E-Da Healthcare Group E-Da Hospital

Which one is K Aoshi U, Taiwan, 970

RECRUITING

Taiwan,

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

New Taipei, Taiwan, 23561

RECRUITING

Taiwan,

Mackey Memorial Hospital

Taipei, Taiwan, 104

RECRUITING

Taiwan,

National Taiwan University Hospital Yumlin Branch

Y UN forest county, Taiwan,

RECRUITING

United Kingdom,

Barts Health NHS Trust St Bartholomew's Hospital

London, United Kingdom, W1G 6AF