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Clinical Trials in the USA / NCT05676931
Active, not recruiting Phase 2

Study With Various Immunotherapy Treatments in Participants With Lung Cancer

NCT05676931 · tracked via the Priya Life Science USA tracker
Sponsor
Gilead Sciences
Phase
Phase 2
Started
2023-02-21
Last updated
2026-06-01

Condition(s) studied

Advanced Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

DomvanalimabQuemliclustatZimberelimabDocetaxelPlatinum-Based Doublet

Domvanalimab: Administered as specified in the treatment arm

Quemliclustat: Administered as specified in the treatment arm

Zimberelimab: Administered as specified in the treatment arm

Docetaxel: Administered as specified in the treatment arm

Platinum-Based Doublet: Administered as specified in the treatment arm

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

Sex
ALL
Min age
18 Years
Max age
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: * 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.

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
University of Alabama at Birmingham (UAB) Birmingham Alabama
University of California San Diego (UCSD) La Jolla California
Memorial Cancer Institute at Memorial Regional Hospital Hollywood Florida
Hematology Oncology Associates Of The Treasure Coast Port Saint Lucie Florida
Florida Cancer Specialists (Administration and Drug Shipment) The Villages Florida
Northwestern Memorial Hospital Chicago Illinois
Ochsner Clinic Foundation Jefferson Louisiana
Henry Ford Hospital Detroit Michigan
Virginia Cancer Specialists, PC Fairfax Virginia
Medical Oncology Associated, PS (dba Summit Cancer Centers) Spokane Washington
The Border Cancer Hospital Albury New South Wales
Pindara Private Hospital Benowa Queensland
Cancer Research SA Pty Ltd Adelaide South Australia
Sir Charles Gairdner Hospital Nedlands Western Australia
CHU Bordeaux Centre Francois Magendie Hôpital du Haut Lévèque Bordeaux France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud Lyon France
Institut De Cancerologie Strasbourg Europe ICANS Strasboug 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 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 South Korea
Chonam National University Hwasun Hospital Hwasun-gun South Korea
Korea University Guro Hospital Seoul South Korea
Asan Medical Center Seoul South Korea
Hospital de la Santa Creu i Sant Pau Barcelona Spain
Hospital Universitari Mutua Terrassa Barcelona Spain
UOMI Cancer Centre Barcelona Spain

+ 13 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05676931 on ClinicalTrials.gov ↗ ← All trials in the USA